Brief Summary
A Prospective, Multicenter, Randomized, Two-Arm, Single-blind Superiority Trial to Evaluate the Safety and Efficacy of the MagicTouch™ Sirolimus- Coated Balloon in the Treatment of Coronary Drug-Eluting Stent In-Stent Restenosis.
Subjects with prior DES implantation presenting with ISR lesions undergoing PCI will be randomized into two groups: treatment with the MagicTouch™ sirolimus-coated balloon or POBA on a 2:1 basis. Approximately 492 subjects will be enrolled in the randomized study in a maximum of 50 study sites located in the United States.
The goal is to establish the safety and efficacy of the MagicTouch™ sirolimus- coated balloon in treatment of coronary in-stent restenosis (ISR).
Subjects with prior DES implantation presenting with ISR lesions undergoing PCI will be randomized into two groups: treatment with the MagicTouch™ sirolimus-coated balloon or POBA on a 2:1 basis. Approximately 492 subjects will be enrolled in the randomized study in a maximum of 50 study sites located in the United States.
The goal is to establish the safety and efficacy of the MagicTouch™ sirolimus- coated balloon in treatment of coronary in-stent restenosis (ISR).
Brief Title
MagicTouch for Treatment of In-Stent Restenosis in Coronary Artery Lesions
Detailed Description
All subjects providing informed consent will have their medical history reviewed and will undergo a physical examination, laboratory screen, and a standardized 12-lead ECG within 7 days of procedure. Women of childbearing potential will have a pregnancy test within one week prior to the procedure. If subjects meet the inclusion and exclusion criteria of the study, they will be randomized to one of two treatment groups, and will then undergo treatment with MagicTouch™ sirolimus-coated balloon or POBA of the target ISR lesion, per trial protocol.
One pre-procedure and all post-procedure biomarker blood draws will be sent to a central core laboratory for analysis of troponin T. Evaluation of post-procedural biomarker blood draws in local laboratories are not mandated but may be performed as part of standard of care.
During the index hospitalization, patients will undergo a clinical assessment and 12-lead ECG; and they will have cardiac biomarkers drawn before the intervention to establish baseline biomarker level and confirmation that the biomarkers are falling. At least one post procedure biomarker (core lab) will be drawn at a minimum of 4 hours after PCI as part of the assessment of periprocedural myocardial infarction and significant periprocedural myocardial injury (at 6-8 hour intervals depending on whether the patient remains admitted). If no procedural complications have occurred and there are no signs of ischemia on post-procedure ECG or clinical assessment, the patient may be discharged per local practice and no additional biomarker levels need to be drawn (beyond the protocol-mandated core laboratory draw at a minimum of 4 hours). If the patient remains admitted cardiac biomarkers (core lab) should be drawn every 6-8 hours until at least 2 total post-procedural core laboratory biomarker draws have passed or clinical standard-based biomarker levels have peaked per local labs or the patient is discharged.
After hospital discharge, subjects will be followed at 30 days (+1 week), 6 months (+2 weeks), and 12 months (+1 month) and then 24, 36, 48 and 60 months (+1 month) post procedure. Yearly vital status information will be collected by telephone follow-up. At the 12-month visit, subjects will undergo 12-lead ECG, blood count, coagulation profile and blood chemistry tests. New and ongoing AEs and concomitant medications will also be assessed.
All elective angiograms performed on the target vessel during the 12-month follow-up period should be preceded by a physician evaluation, during which the physician will indicate whether the subject's clinical status warrants revascularization, i.e. the subject has clinical evidence of ischemia. All films, including unscheduled angiograms, are to be sent to the angiographic core laboratory for review. The angiographic core laboratory will be blinded.
One pre-procedure and all post-procedure biomarker blood draws will be sent to a central core laboratory for analysis of troponin T. Evaluation of post-procedural biomarker blood draws in local laboratories are not mandated but may be performed as part of standard of care.
During the index hospitalization, patients will undergo a clinical assessment and 12-lead ECG; and they will have cardiac biomarkers drawn before the intervention to establish baseline biomarker level and confirmation that the biomarkers are falling. At least one post procedure biomarker (core lab) will be drawn at a minimum of 4 hours after PCI as part of the assessment of periprocedural myocardial infarction and significant periprocedural myocardial injury (at 6-8 hour intervals depending on whether the patient remains admitted). If no procedural complications have occurred and there are no signs of ischemia on post-procedure ECG or clinical assessment, the patient may be discharged per local practice and no additional biomarker levels need to be drawn (beyond the protocol-mandated core laboratory draw at a minimum of 4 hours). If the patient remains admitted cardiac biomarkers (core lab) should be drawn every 6-8 hours until at least 2 total post-procedural core laboratory biomarker draws have passed or clinical standard-based biomarker levels have peaked per local labs or the patient is discharged.
After hospital discharge, subjects will be followed at 30 days (+1 week), 6 months (+2 weeks), and 12 months (+1 month) and then 24, 36, 48 and 60 months (+1 month) post procedure. Yearly vital status information will be collected by telephone follow-up. At the 12-month visit, subjects will undergo 12-lead ECG, blood count, coagulation profile and blood chemistry tests. New and ongoing AEs and concomitant medications will also be assessed.
All elective angiograms performed on the target vessel during the 12-month follow-up period should be preceded by a physician evaluation, during which the physician will indicate whether the subject's clinical status warrants revascularization, i.e. the subject has clinical evidence of ischemia. All films, including unscheduled angiograms, are to be sent to the angiographic core laboratory for review. The angiographic core laboratory will be blinded.
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
+393292467132
Central Contact Email
dario@conceptmedical.com
Central Contact Role
Contact
Central Contact Phone
+919725495366
Central Contact Email
farhana@conceptmedical.com
Completion Date
Completion Date Type
Estimated
Conditions
In-Stent Restenosis
Cardiovascular Diseases
Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria:
1. Subject is at least 18 years old
2. Subject (or legal guardian) understands the trial requirements and treatment procedures and provides written informed consent prior to any trial-specific tests or treatment
3. Patient with an indication for PCI due to suspected in-stent restenosis
4. Non-target lesion PCI are allowed in non-target vessels to be treated with approved interventional devices prior to randomization as follows:
Angiographic Inclusion Criteria:
1. In-stent restenosis after drug-eluting stent implantation(s) in the target lesion (i.e. single and multiple stent layer ISR cases are eligible)
2. Target lesion must have visually estimated stenosis ≥50% and less than 100% diameter stenosis in symptomatic patients; or a visually estimated target lesion diameter stenosis of ≥70%, or by evidence of ischemia by coronary physiology (fractional flow reserve \[FFR\] ≤0.80 or non-hyperemic pressure ratio \[NHPR\] ≤0.89) in absence of symptoms
3. Successful lesion preparation (residual stenosis \<30%), without complications (no or slow flow, flow-limiting dissection, perforation, distal embolization) and without plan for stenting
4. Target lesion in a native coronary artery
5. Thrombolysis In Myocardial Infartction (TIMI) grade flow ≥1 in target lesion
6. Target reference vessel diameter (visual estimation) \>2.0 and ≤4.0 mm
7. Target lesion length (including tandem lesions) ≤36.0 mm (visual estimation) and can be covered by only one balloon
8. One ISR target lesion (overlapping stents are allowed) to be treated per patient and in single major coronary artery or side branch (reference vessel diameter \>2.0 mm)
9. Other coronary lesions (ISR or non-ISR) in non-target vessel are allowed and may be treated by any approved interventional device, but must be treated successfully prior to randomization
Exclusion Criteria:
General Exclusion Criteria (all must be absent for the patient to be eligible):
1. STEMI within 72 hours of presentation to the first treating hospital, whether a transfer facility or the study hospital
2. NSTEACS in whom the biomarkers have not peaked
3. PCI within the 24 hours prior to the index procedure (not including PCI performed in non-target lesions during the index procedure)
4. Prior DCB treatment (coronary or off-label peripheral) of target lesion ISR
5. Cardiogenic shock (defined as persistent hypotension \[systolic blood pressure \<90 mm Hg\] or requiring vasoactive or hemodynamic support, including IABP)
6. Subject is intubated
7. Known left ventricular ejection fraction \<30%
8. Relative or absolute contraindication to DAPT for at least 1 month (e.g., planned surgeries that cannot be delayed)
9. Subject has an indication for chronic oral anticoagulation treatment and a contraindication for concomitant treatment with a P2Y12 inhibitor
10. If femoral access is planned, significant peripheral arterial disease which precludes safe insertion of a 6F sheath
11. Hemoglobin \<9 g/dL
12. Platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3
13. White blood cell count \<3,000 cells/mm3
14. Active infection undergoing treatment
15. Clinically significant liver disease
16. Renal insufficiency as defined by estimated glomerular filtration rate (eGFR) to be \<30ml/min by the MDRD formula
17. Active peptic ulcer or active bleeding from any site
18. Bleeding from any site requiring active medical attention within the prior 8 weeks
19. History of bleeding diathesis or coagulopathy or likely to refuse blood transfusions
20. Cerebrovascular accident (CVA) within 3 months or has any permanent neurological defect as a result of CVA
21. Known allergy to the study device components or protocol-required concomitant medications:
- sirolimus (as well as other limus drugs, analogues, or similar compounds), aspirin, clopidogrel and prasugrel and ticagrelor, heparin and bivalirudin, or iodinated contrast that cannot be adequately pre-medicated
22. Any co-morbid condition that may cause non-compliance with the protocol (e.g. dementia, substance abuse, etc.) or reduce life expectancy to \<24 months (e.g. cancer, heart failure, lung disease, severe valvular disease)
23. Patient is participating in or plans to participate in any other investigational drug or device trial that has not reached its primary endpoint
24. Women who are pregnant or breastfeeding (women of child-bearing potential must have a negative pregnancy test within one week before index procedure)
25. Women who intend to become pregnant within 12 months after the index procedure
26. Patient has received an organ transplant or is on a waiting list for an organ transplant
27. Patient has received chemotherapy within 30 days before the index procedure or scheduled to receive chemotherapy any time after the index procedure
28. Patient is receiving oral or intravenous immunosuppressive therapy or has known life-limiting immunosuppressive or autoimmune disease. Inhaled steroid and steroid use for contrast- allergy prophylaxis or treatment are allowed
Angiographic Exclusion Criteria (visual estimate) (all must be absent for the patient to be eligible):
1. More than 1 ISR lesion in the target vessel in segments that cannot be treated by a single 40mm length DCB (see Angiographic Inclusions #5 and #6 above)
2. ISR lesion in the target vessel in a segment that corresponds to a previously established/documented bare metal stent (BMS)
3. Unprotected left main lesions \>50% or left main intervention
4. Primary PCI for STEMI
5. Coronary artery disease judged more suitable for surgical revascularization per guidelines and local heart team discussion
6. Another lesion in either the target vessel or non-target vessel is present that requires or has a high probability of requiring PCI within 12 months after the index procedure
7. Prior brachytherapy or DCB treatment of target lesion
8. Target lesion is a bifurcation restenosis involving both branches of a bifurcation in which the side branch reference vessel diameter is \>2.0 mm
9. Target lesions located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft
10. Target lesion contains large thrombus
11. Target lesion is heavily calcified
12. Target lesion is a chronic total occlusion (or subtotal) without adequate lesion preparation.\* Total and subtotal occlusions may be enrolled assuming they can be crossed with a wire and demonstrate TIMI grade 3 flow at the time of randomization.
13. Diffuse distal disease to target lesion with impaired runoff
1. Subject is at least 18 years old
2. Subject (or legal guardian) understands the trial requirements and treatment procedures and provides written informed consent prior to any trial-specific tests or treatment
3. Patient with an indication for PCI due to suspected in-stent restenosis
4. Non-target lesion PCI are allowed in non-target vessels to be treated with approved interventional devices prior to randomization as follows:
Angiographic Inclusion Criteria:
1. In-stent restenosis after drug-eluting stent implantation(s) in the target lesion (i.e. single and multiple stent layer ISR cases are eligible)
2. Target lesion must have visually estimated stenosis ≥50% and less than 100% diameter stenosis in symptomatic patients; or a visually estimated target lesion diameter stenosis of ≥70%, or by evidence of ischemia by coronary physiology (fractional flow reserve \[FFR\] ≤0.80 or non-hyperemic pressure ratio \[NHPR\] ≤0.89) in absence of symptoms
3. Successful lesion preparation (residual stenosis \<30%), without complications (no or slow flow, flow-limiting dissection, perforation, distal embolization) and without plan for stenting
4. Target lesion in a native coronary artery
5. Thrombolysis In Myocardial Infartction (TIMI) grade flow ≥1 in target lesion
6. Target reference vessel diameter (visual estimation) \>2.0 and ≤4.0 mm
7. Target lesion length (including tandem lesions) ≤36.0 mm (visual estimation) and can be covered by only one balloon
8. One ISR target lesion (overlapping stents are allowed) to be treated per patient and in single major coronary artery or side branch (reference vessel diameter \>2.0 mm)
9. Other coronary lesions (ISR or non-ISR) in non-target vessel are allowed and may be treated by any approved interventional device, but must be treated successfully prior to randomization
Exclusion Criteria:
General Exclusion Criteria (all must be absent for the patient to be eligible):
1. STEMI within 72 hours of presentation to the first treating hospital, whether a transfer facility or the study hospital
2. NSTEACS in whom the biomarkers have not peaked
3. PCI within the 24 hours prior to the index procedure (not including PCI performed in non-target lesions during the index procedure)
4. Prior DCB treatment (coronary or off-label peripheral) of target lesion ISR
5. Cardiogenic shock (defined as persistent hypotension \[systolic blood pressure \<90 mm Hg\] or requiring vasoactive or hemodynamic support, including IABP)
6. Subject is intubated
7. Known left ventricular ejection fraction \<30%
8. Relative or absolute contraindication to DAPT for at least 1 month (e.g., planned surgeries that cannot be delayed)
9. Subject has an indication for chronic oral anticoagulation treatment and a contraindication for concomitant treatment with a P2Y12 inhibitor
10. If femoral access is planned, significant peripheral arterial disease which precludes safe insertion of a 6F sheath
11. Hemoglobin \<9 g/dL
12. Platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3
13. White blood cell count \<3,000 cells/mm3
14. Active infection undergoing treatment
15. Clinically significant liver disease
16. Renal insufficiency as defined by estimated glomerular filtration rate (eGFR) to be \<30ml/min by the MDRD formula
17. Active peptic ulcer or active bleeding from any site
18. Bleeding from any site requiring active medical attention within the prior 8 weeks
19. History of bleeding diathesis or coagulopathy or likely to refuse blood transfusions
20. Cerebrovascular accident (CVA) within 3 months or has any permanent neurological defect as a result of CVA
21. Known allergy to the study device components or protocol-required concomitant medications:
- sirolimus (as well as other limus drugs, analogues, or similar compounds), aspirin, clopidogrel and prasugrel and ticagrelor, heparin and bivalirudin, or iodinated contrast that cannot be adequately pre-medicated
22. Any co-morbid condition that may cause non-compliance with the protocol (e.g. dementia, substance abuse, etc.) or reduce life expectancy to \<24 months (e.g. cancer, heart failure, lung disease, severe valvular disease)
23. Patient is participating in or plans to participate in any other investigational drug or device trial that has not reached its primary endpoint
24. Women who are pregnant or breastfeeding (women of child-bearing potential must have a negative pregnancy test within one week before index procedure)
25. Women who intend to become pregnant within 12 months after the index procedure
26. Patient has received an organ transplant or is on a waiting list for an organ transplant
27. Patient has received chemotherapy within 30 days before the index procedure or scheduled to receive chemotherapy any time after the index procedure
28. Patient is receiving oral or intravenous immunosuppressive therapy or has known life-limiting immunosuppressive or autoimmune disease. Inhaled steroid and steroid use for contrast- allergy prophylaxis or treatment are allowed
Angiographic Exclusion Criteria (visual estimate) (all must be absent for the patient to be eligible):
1. More than 1 ISR lesion in the target vessel in segments that cannot be treated by a single 40mm length DCB (see Angiographic Inclusions #5 and #6 above)
2. ISR lesion in the target vessel in a segment that corresponds to a previously established/documented bare metal stent (BMS)
3. Unprotected left main lesions \>50% or left main intervention
4. Primary PCI for STEMI
5. Coronary artery disease judged more suitable for surgical revascularization per guidelines and local heart team discussion
6. Another lesion in either the target vessel or non-target vessel is present that requires or has a high probability of requiring PCI within 12 months after the index procedure
7. Prior brachytherapy or DCB treatment of target lesion
8. Target lesion is a bifurcation restenosis involving both branches of a bifurcation in which the side branch reference vessel diameter is \>2.0 mm
9. Target lesions located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft
10. Target lesion contains large thrombus
11. Target lesion is heavily calcified
12. Target lesion is a chronic total occlusion (or subtotal) without adequate lesion preparation.\* Total and subtotal occlusions may be enrolled assuming they can be crossed with a wire and demonstrate TIMI grade 3 flow at the time of randomization.
13. Diffuse distal disease to target lesion with impaired runoff
Inclusion Criteria
Inclusion Criteria:
1. Subject is at least 18 years old
2. Subject (or legal guardian) understands the trial requirements and treatment procedures and provides written informed consent prior to any trial-specific tests or treatment
3. Patient with an indication for PCI due to suspected in-stent restenosis
4. Non-target lesion PCI are allowed in non-target vessels to be treated with approved interventional devices prior to randomization as follows:
Angiographic Inclusion Criteria:
1. In-stent restenosis after drug-eluting stent implantation(s) in the target lesion (i.e. single and multiple stent layer ISR cases are eligible)
2. Target lesion must have visually estimated stenosis ≥50% and less than 100% diameter stenosis in symptomatic patients; or a visually estimated target lesion diameter stenosis of ≥70%, or by evidence of ischemia by coronary physiology (fractional flow reserve \[FFR\] ≤0.80 or non-hyperemic pressure ratio \[NHPR\] ≤0.89) in absence of symptoms
3. Successful lesion preparation (residual stenosis \<30%), without complications (no or slow flow, flow-limiting dissection, perforation, distal embolization) and without plan for stenting
4. Target lesion in a native coronary artery
5. Thrombolysis In Myocardial Infartction (TIMI) grade flow ≥1 in target lesion
6. Target reference vessel diameter (visual estimation) \>2.0 and ≤4.0 mm
7. Target lesion length (including tandem lesions) ≤36.0 mm (visual estimation) and can be covered by only one balloon
8. One ISR target lesion (overlapping stents are allowed) to be treated per patient and in single major coronary artery or side branch (reference vessel diameter \>2.0 mm)
9. Other coronary lesions (ISR or non-ISR) in non-target vessel are allowed and may be treated by any approved interventional device, but must be treated successfully prior to randomization
1. Subject is at least 18 years old
2. Subject (or legal guardian) understands the trial requirements and treatment procedures and provides written informed consent prior to any trial-specific tests or treatment
3. Patient with an indication for PCI due to suspected in-stent restenosis
4. Non-target lesion PCI are allowed in non-target vessels to be treated with approved interventional devices prior to randomization as follows:
Angiographic Inclusion Criteria:
1. In-stent restenosis after drug-eluting stent implantation(s) in the target lesion (i.e. single and multiple stent layer ISR cases are eligible)
2. Target lesion must have visually estimated stenosis ≥50% and less than 100% diameter stenosis in symptomatic patients; or a visually estimated target lesion diameter stenosis of ≥70%, or by evidence of ischemia by coronary physiology (fractional flow reserve \[FFR\] ≤0.80 or non-hyperemic pressure ratio \[NHPR\] ≤0.89) in absence of symptoms
3. Successful lesion preparation (residual stenosis \<30%), without complications (no or slow flow, flow-limiting dissection, perforation, distal embolization) and without plan for stenting
4. Target lesion in a native coronary artery
5. Thrombolysis In Myocardial Infartction (TIMI) grade flow ≥1 in target lesion
6. Target reference vessel diameter (visual estimation) \>2.0 and ≤4.0 mm
7. Target lesion length (including tandem lesions) ≤36.0 mm (visual estimation) and can be covered by only one balloon
8. One ISR target lesion (overlapping stents are allowed) to be treated per patient and in single major coronary artery or side branch (reference vessel diameter \>2.0 mm)
9. Other coronary lesions (ISR or non-ISR) in non-target vessel are allowed and may be treated by any approved interventional device, but must be treated successfully prior to randomization
Gender
All
Gender Based
false
Keywords
Drug coated balloon
Sirolimus coated balloon
ISR
Magic Touch
SCB
Concept Medical
MAGICAL ISR
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
110 Years
Minimum Age
18 Years
NCT Id
NCT05908331
Org Class
Industry
Org Full Name
Concept Medical Inc.
Org Study Id
CM-US-R02
Overall Status
Recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
MagicTouch Sirolimus-coated Balloon for Treatment of In-Stent Restenosis in Coronary Artery Lesions
Primary Outcomes
Outcome Description
The composite rate of cardiac death, target-vessel MI (Myocardial Infarction) or ischemia-driven TLR (Target Lesion Revascularization)
Outcome Measure
TLF (Target Lesion Failure)
Outcome Time Frame
12 months
Secondary Outcomes
Outcome Description
composite of cardiovascular mortality, any MI (Myocardial Infarction), and ID-TLR (Ischemia-Driven Target Lesion Revascularization)
Outcome Time Frame
30 days and 6, 12, 24, 36, 48, and 60 months
Outcome Measure
MACE (Major adverse cardiovascular events)
Outcome Description
composite of cardiovascular mortality, ID-TVR (Ischemia-Driven Target Vessel Revascularization), and TV-MI (Target Vessel Myocardial Infarction)
Outcome Time Frame
30 days and 6, 12, 24, 36, 48, and 60 months
Outcome Measure
TVF (Target vessel failure)
Outcome Description
any repeat PCI or CABG
Outcome Time Frame
30 days and 6, 12, 24, 36, 48, and 60 months
Outcome Measure
Any revascularization
Outcome Description
Repeat revascularization of the target lesion due to recurrent ischemia
Outcome Time Frame
30 days and 6, 12, 24, 36, 48, and 60 months
Outcome Measure
ID-TLR (Ischemia-Driven Target Lesion Revascularization)
Outcome Description
Repeat revascularization of the target lesion
Outcome Time Frame
30 days and 6, 12, 24, 36, 48, and 60 months
Outcome Measure
TLR (Target Lesion Revascularization)
Outcome Description
Repeat revascularization of the target vessel due to recurrent ischemia
Outcome Time Frame
30 days and 6, 12, 24, 36, 48, and 60 months
Outcome Measure
ID-TVR (Ischemia-Driven Target Vessel Revascularization)
Outcome Description
Repeat revascularization of the target vessel
Outcome Time Frame
30 days and 6, 12, 24, 36, 48, and 60 months
Outcome Measure
TVR (Target Vessel Revascularization)
Outcome Description
Death from any cause
Outcome Time Frame
30 days and 6, 12, 24, 36, 48, and 60 months
Outcome Measure
All-cause mortality
Outcome Description
Death due to coronary artery disease or complications of coronary treatment
Outcome Time Frame
30 days and 6, 12, 24, 36, 48, and 60 months
Outcome Measure
Cardiovascular mortality
Outcome Description
Any Myocardial Infarction
Outcome Time Frame
30 days and 6, 12, 24, 36, 48, and 60 months
Outcome Measure
Any MI (Myocardial Infarction)
Outcome Description
Myocardial Infarction related to the target vessel
Outcome Time Frame
30 days and 6, 12, 24, 36, 48, and 60 months
Outcome Measure
TV-MI (Target Vessel Myocardial Infarction)
Outcome Description
Myocardial Infarction demonstrated by new pathological Q waves on ECG
Outcome Time Frame
30 days and 6, 12, 24, 36, 48, and 60 months
Outcome Measure
Q-wave MI (Myocardial Infarction)
Outcome Description
Myocardial Infarction not demonstrated by new pathological Q waves on ECG
Outcome Time Frame
30 days and 6, 12, 24, 36, 48, and 60 months
Outcome Measure
Non-Q-wave MI (Myocardial Infarction)
Outcome Description
Either cardiovascular death or any Myocardial Infarction
Outcome Time Frame
30 days and 6, 12, 24, 36, 48, and 60 months
Outcome Measure
Cardiovascular mortality or MI (Myocardial Infarction)
Outcome Description
Either death from any cause or any Myocardial Infarction
Outcome Time Frame
30 days and 6, 12, 24, 36, 48, and 60 months
Outcome Measure
All-cause mortality or MI (Myocardial Infarction)
Outcome Description
Death from any cause, any Myocardial Infarction, or Target Vessel Revascularization
Outcome Time Frame
30 days and 6, 12, 24, 36, 48, and 60 months
Outcome Measure
All-cause mortality, MI (Myocardial Infarction), or TVR (Target Vessel Revascularization)
Outcome Description
Definite or probable stent thrombosis in the target lesion according to the ARC (Academic Research Consortium) definition
Outcome Time Frame
30 days and 6, 12, 24, 36, 48, and 60 months
Outcome Measure
Any definite or probable target lesion stent thrombosis by ARC (Academic Research Consortium) criteria
Outcome Description
Probable stent thrombosis in the target lesion according to the ARC definition
Outcome Time Frame
30 days and 6, 12, 24, 36, 48, and 60 months
Outcome Measure
Probable target lesion stent thrombosis by ARC (Academic Research Consortium) criteria
Outcome Description
Definite stent thrombosis in the target lesion according to the ARC definition
Outcome Time Frame
30 days and 6, 12, 24, 36, 48, and 60 months
Outcome Measure
Definite target lesion stent thrombosis by ARC (Academic Research Consortium) criteria
Outcome Description
Significant or severe bleeding according to the BARC definition
Outcome Time Frame
30 days and 6, 12, 24, 36, 48, and 60 months
Outcome Measure
BARC (Bleeding Academic Research Consortium) type 3-5 bleeding
Outcome Description
ability to deliver the device and achieve a less than 30% residual stenosis by QCA (quantitative coronary angiography) without major complication or bailout stenting
Outcome Time Frame
30 days and 6, 12, 24, 36, 48, and 60 months
Outcome Measure
Procedure Success
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
110
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Judah Rauch
Investigator Email
jrauch@montefiore.org
Investigator Phone
646-668-6437