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Stellarex DCB Versus Standard Balloon Angioplasty for Treatment of Below-The-Knee (BTK) Arteries

NCT03175744 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2023-06-22

No results posted yet for this study

Summary

The purpose is to demonstrate the safety and effectiveness of the Stellarex DCB for the treatment of stenosis or occlusions of below-the-knee arteries.

Conditions

  • Critical Limb Ischemia

Interventions

DEVICE

Stellarex DCB

Intervention with the Stellarex DCB

DEVICE

PTA Catheter

Intervention with an uncoated Standard PTA

Sponsors & Collaborators

  • Philips Healthcare

    collaborator INDUSTRY

  • Spectranetics Corporation

    lead INDUSTRY

Principal Investigators

  • William Gray, MD · Lankenau Heart Institute

  • Mahmood K Razavi, MD · Vascular and Interventional Specialists of Orange

  • Dierk Scheinert, MD · University of Leipzig

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-24
Primary Completion
2022-04-30
Completion
2025-10-31
FDA Device
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Germany

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 NCT03175744 on ClinicalTrials.gov