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The Chocolate Touch Study

NCT02924857 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 333

Last updated 2023-10-30

No results posted yet for this study

Summary

The Chocolate Touch study is a randomized, multi-center, prospective, adaptive study, designed to show sufficient safety and effectiveness of the Chocolate Touch™ for use in superficial femoral or popliteal arteries with the intention of obtaining regulatory approval to market this device in the United States

Conditions

  • Peripheral Artery Disease (PAD)
  • Ischemia
  • Intermittent Claudication

Interventions

DEVICE

Chocolate Touch

The Chocolate Touch™ Paclitaxel Coated Balloon Catheter is indicated for balloon dilatation, after appropriate vessel preparation as needed, of lesions in native superficial femoral or popliteal arteries up to 18 cm in length that are appropriate for angioplasty with balloon diameters from 3.5 mm to 6.0mm.

DEVICE

Lutonix Drug Coated Balloon

The Lutonix® 035 Drug Coated Balloon Catheter is indicated for improving luminal diameter for the treatment of obstructive de novo or non-stented restenotic lesions (≤ 18 cm in length) in native femoropopliteal arteries having reference vessel diameters of 4 mm to 6 mm.

Sponsors & Collaborators

  • TriReme Medical, LLC

    lead INDUSTRY

Principal Investigators

  • Mehdi Shishehbor, DO · Cleveland Medical Center, Cleveland, Ohio

  • Thomas Zeller, MD · Universitat Herzzentrum, Bad Krozingen, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-26
Primary Completion
2025-06-30
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States
  • Austria
  • Germany
  • 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 NCT02924857 on ClinicalTrials.gov