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The DES BTK Vascular Stent System vs PTA in Subjects With Critical Limb Ischemia

NCT03551496 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 201

Last updated 2024-07-01

Study results available
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Summary

Single phased global, prospective, multicenter clinical trial designed to demonstrate a superior patency rate and acceptable safety in below the knee arteries with lesions treated with the DES BTK Vascular Stent System vs. percutaneous transluminal angioplasty (PTA).

Conditions

  • Critical Limb Ischemia

Interventions

COMBINATION_PRODUCT

Drug Eluting Stent - Below the Knee

Treatment arm with DES-BTK, starting with one size of the device - 3.5 mm X 80 mm

DEVICE

Standard PTA Control Arm

The PTA device used must be market-released in the investigational center's geography and the size (ie, diameter, balloon length and catheter length) will be determined by the investigator.

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Jihad Mustapha, MD · Advanced Cardiac & Vascular Centers for Amputation Prevention

  • Hendrik van Overhagen, MD · HAGA Ziekenhuis (HagaZiekenhuis van Den Haag)

  • Patrick Geraghty, MD · Washington University School of Medicine

  • Masato Nakamura, MD, PhD · Toho University Ohashi Medical Center - Division of Cardiovascular Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-31
Primary Completion
2022-04-21
Completion
2023-12-20
FDA Device
Yes

Countries

  • United States
  • Belgium
  • France
  • Japan
  • Netherlands

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 NCT03551496 on ClinicalTrials.gov