Prevail Global Study

Conditions

• Coronary Artery Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Prevail DCB — DEVICE
  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.
• Agent DCB — DEVICE
  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).

Study Details

The purpose of the study is to evaluate the clinical safety and efficacy of the Prevail DCB.

Key Dates

Start date

Feb 24, 2025

Status verified

Apr 2026

Primary completion

Feb 28, 2027

Completion

Feb 28, 2031

Study Design

Enrollment

1,205 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: ISR Cohort Prevail DCB
  To evaluate the clinical safety and efficacy of the Prevail DCB in the treatment of ISR with coronary lesions previously treated with drug-eluting or bare metal stents in native coronary arteries.
• Experimental: DNSV Cohort (RVD 2.0 - 2.75mm)
  To evaluate the clinical safety and efficacy of the Prevail DCB as compared to a DES historical control in subjects undergoing PCI for de novo lesions in small vessel disease.

Primary Outcome Measure

ISR Cohort Primary Analysis [ Time Frame: 1 year post-procedure ]

Central Contacts

• Jeroen Frijhoff
  +31 (0)43.356.6566
  [email protected]

Locations (51)

Find similar trials in Birmingham, AL

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