Brief Summary
Indication for use: "The Svelte DES is indicated for improving coronary luminal diameter in patients with symptomatic heart disease, including patients with non-ST elevation MI due to discrete de novo native coronary artery lesions. The treated lesion length should be less than the nominal stent length with a reference vessel diameter of 2.25 mm - 4.00 mm
Brief Title
OPTIMIZE IDE for the Treatment of ACS
Categories
Completion Date
Completion Date Type
Actual
Conditions
Acute Coronary Syndrome
Eligibility Criteria
Inclusion Criteria:
* Subject is an eligible candidate for percutaneous coronary intervention (PCI);
* Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia;
* Subject is an acceptable candidate for coronary artery bypass grafting (CABG);
* Subject has up to 3 de novo target lesions in up to 2 native coronary artery vessels, with no more than 2 lesions in a single vessel, each meeting the angiographic criteria and none of the exclusion criteria.
* Target lesion(s) must be located in a native coronary artery with a visually estimated reference vessel diameter (RVD) ≥ 2.25 mm and ≤ 4.00 mm;
Exclusion Criteria:
* The subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmias, or ongoing intractable angina;
* The subject's target lesion(s) is located in the left main artery;
* The subject's target lesion(s) is located within 3 mm of the origin of the left anterior descending (LAD) coronary artery or left circumflex (LCX) coronary artery by visual estimate;
* The subject's target lesion(s) is located within a saphenous vein graft or arterial graft;
* The subject's target lesion(s) will be accessed via a saphenous vein graft or arterial graft;
* Subject is an eligible candidate for percutaneous coronary intervention (PCI);
* Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia;
* Subject is an acceptable candidate for coronary artery bypass grafting (CABG);
* Subject has up to 3 de novo target lesions in up to 2 native coronary artery vessels, with no more than 2 lesions in a single vessel, each meeting the angiographic criteria and none of the exclusion criteria.
* Target lesion(s) must be located in a native coronary artery with a visually estimated reference vessel diameter (RVD) ≥ 2.25 mm and ≤ 4.00 mm;
Exclusion Criteria:
* The subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmias, or ongoing intractable angina;
* The subject's target lesion(s) is located in the left main artery;
* The subject's target lesion(s) is located within 3 mm of the origin of the left anterior descending (LAD) coronary artery or left circumflex (LCX) coronary artery by visual estimate;
* The subject's target lesion(s) is located within a saphenous vein graft or arterial graft;
* The subject's target lesion(s) will be accessed via a saphenous vein graft or arterial graft;
Inclusion Criteria
Inclusion Criteria:
* Subject is an eligible candidate for percutaneous coronary intervention (PCI);
* Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia;
* Subject is an acceptable candidate for coronary artery bypass grafting (CABG);
* Subject has up to 3 de novo target lesions in up to 2 native coronary artery vessels, with no more than 2 lesions in a single vessel, each meeting the angiographic criteria and none of the
* Subject is an eligible candidate for percutaneous coronary intervention (PCI);
* Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia;
* Subject is an acceptable candidate for coronary artery bypass grafting (CABG);
* Subject has up to 3 de novo target lesions in up to 2 native coronary artery vessels, with no more than 2 lesions in a single vessel, each meeting the angiographic criteria and none of the
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03190473
Org Class
Industry
Org Full Name
Svelte Medical Systems, Inc.
Org Study Id
IP-15-001
Overall Status
Terminated
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
The OPTIMIZE Trial to Assess the Procedural and Clinical Value of the Svelte IDS and RX Sirolimus Eluting Coronary Stent Systems for the Treatment of Atherosclerotic Lesions in a Randomized Study
Primary Outcomes
Outcome Measure
Target Lesion Failure (TLF)
Outcome Time Frame
12 months
Secondary Outcomes
Outcome Time Frame
6 and 12 months, and annually through 5 years
Outcome Measure
Target Vessel Failure (TVF)
Outcome Time Frame
6 and 12 months and annually through 5 years follow-up
Outcome Measure
Major Adverse Cardiac Event (MACE)
Outcome Time Frame
6 and 12 months and annually through 5 years follow-up
Outcome Measure
Stent Thrombosis
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)
999
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