The Chocolate Touch Study

Trial details

Who runs it

TriReme Medical, LLC

Trial code

NCT02924857

Record updated

30 October 2023

Original description

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 StatesRead full original descriptionShow less

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

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

Inclusion: 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.

Exclusion: 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; Patient is enrolled in another investigational clinical study or was previously enrolled in this study; Angiographic:; 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.); Known bleeding disorder, or on dialysis, or uncontrolled hypercoagulable disorder; Non-atherosclerotic lesion (e.g. vasculitis or Berger's disease); Presence of perforation, dissection (Type D or worse) or other injury in target vessel at time of enrollment; 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; General:; Female who is pregnant or intends to be pregnant during study; 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).

ClinicalTrials.gov NCT02924857