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.

Heart & Vascular - Peripheral Trials, Heart & Vascular
Paul P. Huang, MD
Matt Ormond

Inclusion Criteria:

  1. Minimum of 18 years of age
  2. Intermittent claudication or ischemic rest pain (Rutherford 2-4)
  3. Life Expectancy >2 years
  4. Patient has agreed to follow-up requirements and given informed consent
  5. Lesion successfully crossed with a guidewire
  6. Lesion in the superficial femoral or popliteal artery
  7. Target lesion >70% stenosis
  8. Reference Vessel Diameter between 3.5 & 6.0mm and within treatment range of Chocolate Touch to be used 1.1:1 at Target Lesion
  9. 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
  10. 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
  11. In-flow vessel without significant stenosis (<70%) or successful treatment (<30% residual stenosis with no complications) of a diseased iliac vessel

Exclusion Criteria:

  1. Acute limb ischemia, or patient indicated for thrombolytic therapy
  2. Planned surgery within 30 days including interventions on the non-target limb
  3. 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
  4. Myocardial infarction or stroke within 30 days prior to the procedure
  5. Known intolerance to required medications, contrast media, nitinol, or Paclitaxel
  6. 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)
  7. Known bleeding disorder or uncontrolled hypercoagulable disorder
  8. Non-atherosclerotic lesion (e.g. vasculitis or Berger's disease)
  9. Female who is pregnant or intends to be pregnant during study
  10. Patient is enrolled in another clinical study or was previously enrolled in this study
  11. Presence of perforation, dissection or other injury at access site or in target vessel at time of enrollment
  12. 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)
  13. 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