NCT02648620

Safety and Feasibility of SurModics SurVeil (TM) Drug Coated Balloon

A Prospective, Multi-Center, Single-Arm Trial to Assess the Safety and Feasibility of the SurModics Drug Coated Balloon in the Treatment of Subjects With De Novo Lesions of the Femoropopliteal Artery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: SurModics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

PREVEIL is a prospective, multi-center, single-arm clinical trial to assess the safety and functionality of the SurModics drug coated balloon (DCB) in the treatment of subjects with symptomatic peripheral artery disease (PAD) due to de novo stenoses of the femoral and popliteal arteries. The trial will enroll up to 15 subjects.

Detailed description

PREVEIL will enroll patients presenting with angiographic evidence of significant stenosis in the femoral or popliteal arteries. All enrolled subjects will be treated with the SurVeil DCB.

Conditions

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Interventions

Type	Name	Description
DEVICE	SurVeil Drug Coated Balloon	Angioplasty procedure with the SurModics SurVeil Paclitaxel-Coated, Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (Paclitaxel-coated PTA Catheter)
PROCEDURE	Angioplasty	Angioplasty procedure with the SurModics SurVeil Paclitaxel-Coated, Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (Paclitaxel-coated PTA Catheter)

Timeline

• Start date: 2016-04-05
• Primary completion: 2017-01-01
• Completion: 2020-02-11
• First posted: 2016-01-07
• Last updated: 2022-07-26

Locations

3 sites across 1 country: United States