Coronary Artery Disease
Conditions
Keywords
ISR, DNSV
Brief summary
The purpose of the study is to evaluate the clinical safety and efficacy of the Prevail DCB.
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.
Interventions
DEVICEPrevail DCB
The Prevail Paclitaxel-coated PTCA Balloon Catheter is intended for percutaneous transluminal coronary angioplasty (PTCA) in the coronary arteries with a vessel diameter from 2.00 mm to 4.00 mm to treat in-stent restenosis (ISR) and to treat de novo lesions in small vessel disease.
DEVICEAgent DCB
The Agent Paclitaxel-coated PTCA Balloon Catheter is intended for percutaneous transluminal coronary angioplasty (PTCA) in the coronary arteries with a vessel diameter from 2.00 mm to 4.00 mm to treat in-stent restenosis (ISR).
Sponsors
Medtronic Vascular
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Masking only applies to the subjects in the ISR Cohort, subjects will be randomized at a 1:1 ratio to treatment with the Prevail DCB or the Agent DCB. Subjects in DNSV Cohort will be prospectively enrolled in the study and treated with Prevail DCB.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ISR Cohort Primary Analysis | 1 year post-procedure | The TLF rate of the Prevail DCB arm at 12 months post procedure compared to the Agent DCB arm for non-inferiority |
| DNSV Cohort Primary Analysis | 1 year post-procedure | The TLF rate of the Prevail DCB arm at 12 months post procedure compared to a DES historical control |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac death | hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months | — |
| All myocardial infarction (MI), including target vessel myocardial infarction (TVMI) | hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months | — |
| Clinically-driven target lesion revascularization (cd-TLR) defined as repeat PCI or CABG to the target lesion | hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months | — |
| Clinically-driven target vessel revascularization (cd-TVR) | hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months | — |
| Acute success | hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months | Acute success (device, lesion, and procedure) through hospital discharge only |
| Target lesion failure (TLF) defined as composite of cardiac death, TVMI, or cd-TLR | hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months | — |
| Target vessel failure (TVF) defined as composite of cardiac death, TVMI, or cd-TVR | hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months | — |
| Target lesion thrombosis (TLT) (definite or probable) according to Academic Research Consortium (ARC) definition | hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months | — |
| Major adverse cardiac event (MACE) defined as composite of death, MI, or repeat cd-TLR | hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months | — |
| All deaths | hospital discharge, 30 days, and 6, 12, 24, 36, 48, and 60 months | — |
Countries
United States
Contacts
Primary ContactJeroen Frijhoff
Outcome results
None listed