Brief Summary
The purpose of the study is to evaluate the clinical safety and efficacy of the Prevail DCB.
Brief Title
Prevail Global Study
Detailed Description
The Prevail Global study is a prospective, premarket, interventional, multi-center, global, dual cohort clinical study enrolling subjects undergoing percutaneous coronary intervention for in-stent restenosis (ISR Cohort) in a randomized controlled study of the Prevail Drug-Coated Balloon, and subjects undergoing percutaneous coronary intervention of the Prevail Drug-Coated Balloon for de novo lesions in small vessel disease (DNSV Cohort) in a single arm prospectively enrolled study.
In the ISR Cohort this will be accomplished by randomizing subjects to either a Prevail DCB arm or an Agent DCB arm to compare results of the treatment of ISR with coronary lesions previously treated with DES or BMS in native coronary arteries. In the DNSV Cohort this will be accomplished through collection of data to compare results of the Prevail DCB to a DES historical control in subjects undergoing PCI for de novo lesions in small vessel disease.
Subjects will be enrolled at approximately 65 study sites; the same study sites will be used for enrollment of both cohorts. The enrollment period is anticipated to be approximately 12 months. Subjects will remain in the study with follow-up clinical assessments through 5 years, study exit, or death, whichever comes first.
In the ISR Cohort this will be accomplished by randomizing subjects to either a Prevail DCB arm or an Agent DCB arm to compare results of the treatment of ISR with coronary lesions previously treated with DES or BMS in native coronary arteries. In the DNSV Cohort this will be accomplished through collection of data to compare results of the Prevail DCB to a DES historical control in subjects undergoing PCI for de novo lesions in small vessel disease.
Subjects will be enrolled at approximately 65 study sites; the same study sites will be used for enrollment of both cohorts. The enrollment period is anticipated to be approximately 12 months. Subjects will remain in the study with follow-up clinical assessments through 5 years, study exit, or death, whichever comes first.
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
7075250111
Central Contact Email
rs.prevailglobal@medtronic.com
Completion Date
Completion Date Type
Estimated
Conditions
Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria:
* ≥ 18 years
* Negative pregnancy test
* Stable or unstable angina, positive functional test, or stable NSTEMI
* Life expectancy \>1 year
* Willing and able to cooperate with study procedures and required follow up evaluations
Exclusion Criteria:
* Known hypersensitivity or contraindication to antiplatelet medications or a sensitivity to contrast media which cannot be adequately pre-medicated
* History of an allergic reaction or significant sensitivity to paclitaxel or any other analogue or derivative
* Platelet count \< 100,000 cells/mm³ or \> 700,000 cells/mm³, or a white blood cell (WBC) count \< 3,000 cells/mm³
* Renal insufficiency (or failure)
* Acute MI
* Previous PCI of the target vessel within 6 months prior to the procedure
* Planned PCI of any vessel within 30 days post-index procedure and/or planned PCI of the target vessel within 12 months post-procedure
* History of a stroke or transient ischemic attack (TIA)
* Active peptic ulcer or upper gastrointestinal (GI) bleeding
* History of bleeding diathesis or coagulopathy or will refuse blood transfusions
* Documented left ventricular ejection fraction (LVEF) \<30%
* Planned surgery that would cause interruption in recommended DAPT duration per current guidelines
* Currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints; or requires additional coronary angiography, IVUS or other coronary artery imaging procedures
* ≥ 18 years
* Negative pregnancy test
* Stable or unstable angina, positive functional test, or stable NSTEMI
* Life expectancy \>1 year
* Willing and able to cooperate with study procedures and required follow up evaluations
Exclusion Criteria:
* Known hypersensitivity or contraindication to antiplatelet medications or a sensitivity to contrast media which cannot be adequately pre-medicated
* History of an allergic reaction or significant sensitivity to paclitaxel or any other analogue or derivative
* Platelet count \< 100,000 cells/mm³ or \> 700,000 cells/mm³, or a white blood cell (WBC) count \< 3,000 cells/mm³
* Renal insufficiency (or failure)
* Acute MI
* Previous PCI of the target vessel within 6 months prior to the procedure
* Planned PCI of any vessel within 30 days post-index procedure and/or planned PCI of the target vessel within 12 months post-procedure
* History of a stroke or transient ischemic attack (TIA)
* Active peptic ulcer or upper gastrointestinal (GI) bleeding
* History of bleeding diathesis or coagulopathy or will refuse blood transfusions
* Documented left ventricular ejection fraction (LVEF) \<30%
* Planned surgery that would cause interruption in recommended DAPT duration per current guidelines
* Currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints; or requires additional coronary angiography, IVUS or other coronary artery imaging procedures
Inclusion Criteria
Inclusion Criteria:
* ≥ 18 years
* Negative pregnancy test
* Stable or unstable angina, positive functional test, or stable NSTEMI
* Life expectancy \>1 year
* Willing and able to cooperate with study procedures and required follow up evaluations
* ≥ 18 years
* Negative pregnancy test
* Stable or unstable angina, positive functional test, or stable NSTEMI
* Life expectancy \>1 year
* Willing and able to cooperate with study procedures and required follow up evaluations
Gender
All
Gender Based
false
Keywords
ISR
DNSV
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT06535854
Org Class
Industry
Org Full Name
Medtronic Vascular
Org Study Id
MDT22021
Overall Status
Recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
A Randomized Controlled Study of the Prevail Drug-Coated Balloon in Subjects With In-stent Restenosis and a Single Arm Prospectively Enrolled Study of the Prevail Drug-Coated Balloon for de Novo Lesions in Small Vessel Disease (Prevail Global).
Primary Outcomes
Outcome Description
The TLF rate of the Prevail DCB arm at 12 months post procedure compared to the Agent DCB arm for non-inferiority
Outcome Measure
ISR Cohort Primary Analysis
Outcome Time Frame
1 year post-procedure
Outcome Description
The TLF rate of the Prevail DCB arm at 12 months post procedure compared to a DES historical control
Outcome Measure
DNSV Cohort Primary Analysis
Outcome Time Frame
1 year post-procedure
Secondary Outcomes
Outcome Description
Acute success (device, lesion, and procedure) through hospital discharge only
Outcome Time Frame
hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
Outcome Measure
Acute success
Outcome Time Frame
hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
Outcome Measure
All deaths
Outcome Time Frame
hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
Outcome Measure
Cardiac death
Outcome Time Frame
hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
Outcome Measure
All myocardial infarction (MI), including target vessel myocardial infarction (TVMI)
Outcome Time Frame
hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
Outcome Measure
Clinically-driven target lesion revascularization (cd-TLR) defined as repeat PCI or CABG to the target lesion
Outcome Time Frame
hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
Outcome Measure
Clinically-driven target vessel revascularization (cd-TVR)
Outcome Time Frame
hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
Outcome Measure
Major adverse cardiac event (MACE) defined as composite of death, MI, or repeat cd-TLR
Outcome Time Frame
hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
Outcome Measure
Target lesion failure (TLF) defined as composite of cardiac death, TVMI, or cd-TLR
Outcome Time Frame
hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
Outcome Measure
Target vessel failure (TVF) defined as composite of cardiac death, TVMI, or cd-TVR
Outcome Time Frame
hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months
Outcome Measure
Target lesion thrombosis (TLT) (definite or probable) according to Academic Research Consortium (ARC) definition
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
Andrea Mignatti
Investigator Email
amignatt@montefiore.org