The Chocolate Touch Study

Running, not enrolling · Not applicable

Conditions studied: Peripheral Artery Disease (PAD), Ischemia, Intermittent Claudication

In brief

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

Key facts

Study ID

NCT02924857

Run by

TriReme Medical, LLC

People needed

333

Starts

2017-07-26

Expected to finish

2026-12-01

Last updated by the study team

2023-10-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• General:
• Minimum of 18 years of age
• Intermittent claudication or ischemic rest pain (Rutherford 2-4)
• Life Expectancy >2 years
• Patient has agreed to follow-up requirements and given informed consent
• Angiographic:
• Lesion successfully crossed with a guidewire
• Lesion in the SFA or popliteal artery defined as a lesion with a proximal origin >10 mm from SFA origin (deep femoral artery) and a distal end above the knee joint (at least 3 cm above bottom of the femur - P1).
• Target Lesion ≥70% stenosis in the SFA or popliteal arteries
• Reference Vessel Diameter (RVD) between 4.0 \& 6.0mm and within treatment range of Chocolate Touch to be used 1.1:1 at the Target Lesion
• Target Lesion ≤180mm that consists of no more than two adjacent lesions (≤ 25mm apart) and is able to be completely covered with inflation of no more than two assigned balloons (with minimum of >5mm overlap to the area covered by the first balloon). (Note: Adjacent or tandem target lesions must be treated as a single lesion.)
• Angiographic evidence of distal run-off demonstrated by at least one patent tibial vessel without evidence of significant (≥70%) stenosis from origin to ankle
• In-flow vessel without significant stenosis (≥70%) or successful treatment (≤30% residual stenosis with no complications) of a diseased vessel. Note: treatment of contralateral iliac is permissible.

You may not qualify if…

• General:
• Acute limb ischemia, or patient indicated for thrombolytic therapy
• Planned surgical or interventional procedures within 30 days after study procedure.
• Non-target lesion concurrent interventions involving a re-entry device, atherectomy, laser, or ablation procedures, the use of a drug eluting stent, or, treatment with any other drug coated balloon.
• Myocardial infarction or stroke within 30 days prior to the procedure
• Known intolerance to required medications, contrast media that cannot be adequately premedicated, nitinol, or Paclitaxel
• Known impaired Renal Function that could have an impact on contrast tolerance with GFR ≤ 30 ml/min per 1.73 m2 and/or elevated serum creatinine >2.5mg/dL (220µmol/L) or on dialysis.
• Known bleeding disorder, or on dialysis, or uncontrolled hypercoagulable disorder
• Non-atherosclerotic lesion (e.g. vasculitis or Berger's disease)
• Female who is pregnant or intends to be pregnant during study
• Patient is enrolled in another investigational clinical study or was previously enrolled in this study
• Angiographic:
• Presence of perforation, dissection (Type D or worse) or other injury in target vessel at time of enrollment
• Severe Calcification at the target lesion (defined as angiographic evidence of dense calcification present on both sides of the vessel wall on two orthogonal views and that extends >50 continuous mm in length).
• Previous bypass graft, stent at target vessel (must be greater than 20mm from target lesion), or iliac stent that cannot permit crossing by the treatment balloon within the introducer sheath (Note: In-stent restenosis is not allowed.)

Where it is running

• 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
• Penn State Health Holy Spirit Medical Center — Camp Hill, Pennsylvania, United States
• Pinnacle Health Cardiovascular Institute — Wormleysburg, Pennsylvania, United States
• Lankenau Medical Center — Wynnewood, 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
• Angiologie - Hansuchkrankenhaus — Vienna, Austria
• Universitat Herz-Zentrum — Bad Krozingen, Germany
• Auckland City Hospital — Auckland, New Zealand
• Waikato Hospital — Hamilton, New Zealand

Full record on ClinicalTrials.gov

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