NCT02924857

The Chocolate Touch Study

A Randomized Trial to Confirm the Safety and Effectiveness of Chocolate Touch™ Paclitaxel Coated Balloon Catheter, in Above the Knee Lesions

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 333 (actual)
• Sponsor: TriReme Medical, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

The primary objective of the Chocolate Touch study is to demonstrate non-inferior safety and non-inferior effectiveness of the Chocolate Touch™ compared to the Lutonix® drug coated balloon catheter. These data are intended to show safety and effectiveness of the Chocolate Touch sufficient to support regulatory approval to market this device in the United States for use in superficial femoral or popliteal arteries. Study success is defined as statistical demonstration of the non-inferiority hypothesis tests for both the primary safety and effectiveness hypothesis. PMA P210039 approval has been granted on 11/04/2022. The study is now in the post-approval phase.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-07-26
• Primary completion: 2025-06-01
• Completion: 2026-12-01
• First posted: 2016-10-05
• Last updated: 2023-10-30

Locations

20 sites across 4 countries: United States, Austria, Germany, New Zealand

Regulatory

• FDA-regulated device study