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

NCT02648620 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2022-07-26

No results posted yet for this study

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.

Conditions

  • Peripheral Arterial Disease
  • Peripheral Vascular Diseases

Interventions

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)

Sponsors & Collaborators

  • SurModics, Inc.

    lead INDUSTRY

Principal Investigators

  • Christopher Metzger, MD, FACC, FSCAI · Wellmont CVA Heart Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-05
Primary Completion
2017-01-31
Completion
2020-02-11

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02648620 on ClinicalTrials.gov