The Chocolate Touch Study - A Randomized Trial to confirm the Safety and Effectiveness of Chocolate Touch Paclitaxel Coated PTA 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.
NCT02924857
Heart & Vascular - Peripheral Trials,
Heart & Vascular
Paul P. Huang, MD
Inclusion Criteria:
- 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
- Lesion successfully crossed with a guidewire
- Lesion in the superficial femoral or popliteal artery
- Target lesion >70% stenosis
- Reference Vessel Diameter between 3.5 & 6.0mm and within treatment range of Chocolate Touch to be used 1.1:1 at Target Lesion
- Target Lesion <15cm 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
- Angiographic evidence of distal run-off demonstrated by at least one patent tibial vessel without evidence of significant (>70%) stenosis from origin to to ankle
- In-flow vessel without significant stenosis (<70%) or successful treatment (<30% residual stenosis with no complications) of a diseased iliac vessel
Exclusion Criteria:
- Acute limb ischemia, or patient indicated for thrombolytic therapy
- Planned surgery within 30 days including interventions on the non-target limb
- Target Limb 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, nitinol, or Paclitaxel
- Known impaired Renal Function that could have an impact on contrast tolerance with Glomerular filtration rate (GFR) ≤ 30 ml/min per 1.73 m^2 and/or elevated serum creatinine >2.5mg/dL (220µmol/L)
- Known bleeding disorder 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 clinical study or was previously enrolled in this study
- Presence of perforation, dissection or other injury at access site or 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 >5 continuous cm in length)
- Previous bypass graft or stent at target vessel, OR, iliac stent that cannot permit crossing by the treatment balloon within the introducer sheath
Elizabeth Vogt, CCRC
206-320-3917
206-215-1500