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NCT02924857 · ClinicalTrials.gov registry record · NA

The Chocolate Touch Study

A NA study of Intermittent Claudication and Ischemia, sponsored by TriReme Medical.

Active
Registry status
NA
Development phase
333
Enrollment target
20
Study locations

NCT02924857: Active NA study of Intermittent Claudication and Ischemia, sponsored by TriReme Medical.

NCT02924857 is a NA study of Intermittent Claudication and Ischemia that is active but no longer recruiting, run by TriReme Medical. The registered enrollment target is 333 participants, above the 186-participant average among 11 other Intermittent Claudication trials with a reported enrollment target (79% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02924857, a NA study of Intermittent Claudication and Ischemia, is active but no longer recruiting, sponsored by TriReme Medical.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
333 participants
Enrollment target
20
Study locations

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

Primary Outcome

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).

Conditions Studied

Intermittent Claudication Ischemia Peripheral Artery Disease (PAD)

Interventions

  • DEVICE Chocolate Touch
  • DEVICE Lutonix Drug Coated Balloon

Study Locations (20)

Other

  • Medical University of Graz - LKH Univ.-Klinikum Graz - Graz
  • Angiologie - Hansuchkrankenhaus - Vienna
  • Universitat Herz-Zentrum - Bad Krozingen
  • Auckland City Hospital - Auckland
  • Waikato Hospital - Hamilton

Pennsylvania

  • Penn State Health Holy Spirit Medical Center - Camp Hill
  • Pinnacle Health Cardiovascular Institute - Wormleysburg
  • Lankenau Medical Center - Wynnewood

Florida

  • Cardiac and Vascular Institute - Gainesville
  • Mt. Sinai - Miami - Miami Beach

New York

  • Mt. Sinai Heart - New York
  • Columbia University Medical Center / NewYork Presbyterian Hospital - New York

Georgia

  • Emory University - Atlanta

Louisiana

  • Cardiovascular Institute of the South - Houma

Michigan

  • Michigan Outpaitient Vascular Institution - Dearborn

Mississippi

  • Jackson Heart - Jackson

Trial Details

FieldValue
Enrollment Target 333 participants
Start Date 2017-07-26
Est. Completion 2026-12
Phase NA
TriReme Medical

3 total trials

What the registry record for NCT02924857 still lists

NCT02924857 is an interventional study that assigns participants to a tested intervention. The registered 333 participants enrollment target is mid-sized for trials with a published cap, above the 186-participant average among 11 other Intermittent Claudication trials with a reported enrollment target (79% higher).

The record links to 3 conditions, with Intermittent Claudication appearing as the primary indexed condition, and to 2 interventions - of which Chocolate Touch is the first listed.

NCT02924857 names 20 study sites across 12 states, led by Other, Pennsylvania, Florida.

Frequently Asked Questions

What is clinical trial NCT02924857 about?

NCT02924857 is a clinical study titled "The Chocolate Touch Study". 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 Uni...

What is the current status of trial NCT02924857?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 333 participants. The study started on 2017-07-26. Estimated completion is 2026-12.

What conditions does trial NCT02924857 study?

This clinical trial studies the following conditions: Intermittent Claudication, Ischemia, Peripheral Artery Disease (PAD).

What interventions are being tested in trial NCT02924857?

The interventions under investigation include: Chocolate Touch (DEVICE), Lutonix Drug Coated Balloon (DEVICE).

Who is sponsoring clinical trial NCT02924857?

This trial is sponsored by TriReme Medical, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02924857 being conducted?

This trial has 20 study locations across Florida, Georgia, Louisiana, Michigan, Mississippi. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Intermittent Claudication

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02924857's enrollment target sits among peer trials

333 3rd of 11 higher than 9 of 11 other Intermittent Claudication trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Intermittent Claudication trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT02924857, the US trial registry maintained by the National Library of Medicine. NCT02924857 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.