The Chocolate Touch Study

Not Applicable

Active, not recruiting

• Conditions: Ischemia; Intermittent Claudication; Peripheral Artery Disease (PAD)

• Registration Number: NCT02924857
• Lead Sponsor: TriReme Medical, LLC

Brief 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.

Study Timeline

• Study First Submitted: 2016-10-03
• Study First Submitted QC: 2016-10-03
• Study First Posted: 2016-10-05
• Study Start: 2017-07-26
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-26
• Last Update Posted: 2023-10-30
• Primary Completion: 2025-06
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 333

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Freedom from Major Adverse Events	12 months	Composite of target-limb-related death, major amputation of the target limb, and clinically driven re-intervention of the target limb.
True Drug Coated Balloon Success	12 months	A composite endpoint that requires patients to achieve Primary Patency (Peak systolic velocity ratio \<2.4 without the need for clinically driven target lesion revascularization) in the absence of a clinically driven bail-out stent (core lab adjudicated).

Secondary Outcome Measures

Name	Time	Method
By Duplex Ultrasound Core Lab Review	6, 12, 24, & 36 months	Patency
By Angiographic Core Lab Review (Acute)	1 hour	Procedural Success: Defined as the success of the therapy to achieve \<30% diameter stenosis without a flow-limiting dissection or the need for a stent
By Clinical Assessment	6, 12, 24, & 36 months	Occurrence of relevant Adverse Events

Trial Locations

Locations (20)

Cardiac and Vascular Institute; 🇺🇸 Gainesville, Florida, United States

Mt. Sinai - Miami; 🇺🇸 Miami Beach, Florida, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

Cardiovascular Institute of the South; 🇺🇸 Houma, Louisiana, United States

Michigan Outpaitient Vascular Institution; 🇺🇸 Dearborn, Michigan, United States

Jackson Heart; 🇺🇸 Jackson, Mississippi, United States

St. Luke's Hospital; 🇺🇸 Kansas City, Missouri, United States

Mt. Sinai Heart; 🇺🇸 New York, New York, United States

Columbia University Medical Center / NewYork Presbyterian Hospital; 🇺🇸 New York, New York, United States

Univeristy Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States

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