πŸ›οΈ Verified NIH Record β€’ Updated 2023-10-26

The Chocolate Touch Study (NCT02924857)

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

πŸ”΅ Active, Not Recruiting Observational / Diagnostic βš™οΈ Medical Device Protocol Sponsor: TriReme Medical, LLC

🩺 Plain-English Summary (8th-Grade Level)

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

Who can join: Review the eligibility criteria below.

Location: Cardiac and Vascular Institute β€” Gainesville, Florida

Age range: 18 Years

πŸ“‹ "Do I Qualify?" β€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria β†—

πŸ“ All Participating Trial Locations (20 Sites)

  • Cardiac and Vascular Institute β€” Gainesville, Florida
  • Mt. Sinai - Miami β€” Miami Beach, Florida
  • Emory University β€” Atlanta, Georgia
  • Cardiovascular Institute of the South β€” Houma, Louisiana
  • Michigan Outpaitient Vascular Institution β€” Dearborn, Michigan
  • Jackson Heart β€” Jackson, Mississippi
  • St. Luke's Hospital β€” Kansas City, Missouri
  • Mt. Sinai Heart β€” New York, New York
  • Columbia University Medical Center / NewYork Presbyterian Hospital β€” New York, New York
  • Univeristy Hospitals Cleveland Medical Center β€” Cleveland, Ohio
  • Penn State Health Holy Spirit Medical Center β€” Camp Hill, Pennsylvania
  • Pinnacle Health Cardiovascular Institute β€” Wormleysburg, Pennsylvania
  • Lankenau Medical Center β€” Wynnewood, Pennsylvania
  • MIssion Research β€” New Braunfels, Texas
  • Swedish Medical Center β€” Seattle, Washington
  • Medical University of Graz - LKH Univ.-Klinikum Graz β€” Graz,
  • Angiologie - Hansuchkrankenhaus β€” Vienna,
  • Universitat Herz-Zentrum β€” Bad Krozingen,
  • Auckland City Hospital β€” Auckland,
  • Waikato Hospital β€” Hamilton,

πŸ’° Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA Β§ 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

πŸ’‘ How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
πŸ›οΈ View Official NIH Record β†—