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Safety and Efficacy of the SurVeil™ Drug-Coated Balloon

NCT03241459 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 446

Last updated 2025-03-25

Study results available
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Summary

To demonstrate the safety and efficacy of the SurVeil Drug-Coated Balloon (DCB) for treatment of subjects with symptomatic peripheral artery disease (PAD) due to stenosis of the femoral and/or popliteal arteries.

Conditions

  • Peripheral Arterial Disease
  • Peripheral Vascular Disease
  • Artery Disease, Peripheral
  • Femoropopliteal Artery Occlusion

Interventions

DEVICE

Surmodics SurVeil DCB

Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.

DEVICE

Medtronic IN.PACT Admiral DCB

Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.

Sponsors & Collaborators

  • SurModics, Inc.

    lead INDUSTRY

Principal Investigators

  • William Gray, MD · Lankenau Heart Group

  • Kenneth Rosenfield, MD · Massachusetts General Hospital

  • Marianne Brodmann, MD · Medical University Graz, Department of Internal Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-23
Primary Completion
2020-09-15
Completion
2024-09-17
FDA Device
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Czechia
  • Germany
  • Italy
  • Latvia
  • New Zealand

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 NCT03241459 on ClinicalTrials.gov