The Chocolate Touch Study

NAActive, not recruitingINTERVENTIONAL
Enrollment

333

Participants

Timeline

Start Date

July 26, 2017

Primary Completion Date

June 30, 2025

Study Completion Date

December 31, 2026

Conditions
Peripheral Artery Disease (PAD)IschemiaIntermittent 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.

Trial Locations (20)

1140

Angiologie - Hansuchkrankenhaus, Vienna

3210

Waikato Hospital, Hamilton

10029

Mt. Sinai Heart, New York

10032

Columbia University Medical Center / NewYork Presbyterian Hospital, New York

17011

Penn State Health Holy Spirit Medical Center, Camp Hill

17043

Pinnacle Health Cardiovascular Institute, Wormleysburg

19096

Lankenau Medical Center, Wynnewood

30322

Emory University, Atlanta

32605

Cardiac and Vascular Institute, Gainesville

33140

Mt. Sinai - Miami, Miami Beach

39216

Jackson Heart, Jackson

44106

Univeristy Hospitals Cleveland Medical Center, Cleveland

48126

Michigan Outpaitient Vascular Institution, Dearborn

64111

St. Luke's Hospital, Kansas City

70360

Cardiovascular Institute of the South, Houma

78130

MIssion Research, New Braunfels

98122

Swedish Medical Center, Seattle

A-0836

Medical University of Graz - LKH Univ.-Klinikum Graz, Graz

Unknown

Universitat Herz-Zentrum, Bad Krozingen

Auckland City Hospital, Auckland

All Listed Sponsors
lead

TriReme Medical, LLC

INDUSTRY

NCT02924857 - The Chocolate Touch Study | Biotech Hunter | Biotech Hunter