The Chocolate Touch Study
- Conditions
- IschemiaIntermittent ClaudicationPeripheral Artery Disease (PAD)
- Interventions
- Device: Chocolate TouchDevice: Lutonix Drug Coated Balloon
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 333
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Test Group (Chocolate Touch) Chocolate Touch * The diameter of the Chocolate Touch should correspond to the diameter of the vessel for treatment with a balloon to artery ratio of 1.1:1. * The Chocolate Touch must be inflated to at least nominal pressure. Maintain balloon inflation for a minimum of 2 minutes. The balloon may be inflated as long as required to achieve optimal angioplasty outcome. * If delivery is attempted and failed, a new Chocolate Touch should be used for subsequent attempts after pre-dilatation. Control Group (Lutonix Drug Coated Balloon) Lutonix Drug Coated Balloon * Never inflate the Lutonix® Drug Coated Balloon (DCB)prior to reaching the target lesion. * The Lutonix® Catheter should be advanced to the target site as fast as possible (i.e. 30 seconds) and immediately inflated to appropriate pressure to ensure full wall apposition (balloon to artery ratio of \>1:1). * If the deployment of the Lutonix® Catheter exceeds 3 minutes, the catheter requires placement with a new unit. * Maintain balloon inflation for a minimum of 2 minutes (120 seconds). The balloon may be inflated as long as required by standard of care to achieve a good angioplasty outcome.
- 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)
Lankenau Medical Center
🇺🇸Wynnewood, Pennsylvania, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Cardiac and Vascular Institute
🇺🇸Gainesville, Florida, United States
Mt. Sinai Heart
🇺🇸New York, New York, United States
Cardiovascular Institute of the South
🇺🇸Houma, Louisiana, United States
Michigan Outpaitient Vascular Institution
🇺🇸Dearborn, Michigan, United States
St. Luke's Hospital
🇺🇸Kansas City, Missouri, United States
Jackson Heart
🇺🇸Jackson, Mississippi, United States
Univeristy Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Columbia University Medical Center / NewYork Presbyterian Hospital
🇺🇸New York, New York, United States
Pinnacle Health Cardiovascular Institute
🇺🇸Wormleysburg, Pennsylvania, United States
Mt. Sinai - Miami
🇺🇸Miami Beach, Florida, United States
Penn State Health Holy Spirit Medical Center
🇺🇸Camp Hill, Pennsylvania, United States
MIssion Research
🇺🇸New Braunfels, Texas, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
Medical University of Graz - LKH Univ.-Klinikum Graz
🇦🇹Graz, Austria
Universitat Herz-Zentrum
🇩🇪Bad Krozingen, Germany
Angiologie - Hansuchkrankenhaus
🇦🇹Vienna, Austria
Auckland City Hospital
🇳🇿Auckland, New Zealand
Waikato Hospital
🇳🇿Hamilton, New Zealand