Interventional study for certain patients diagnosed with peripheral valve disease or ischemia

Study ID: Chocolate Touch

The Chocolate Touch study

This study is for patients diagnosed with intermittent claudication of peripheral valves and/or ischemia. Participants will be assigned to one of two study arms.

  • Arm 1 will be treated with the Chocolate Touch™ Paclitaxel coated balloon catheter as indicated for balloon dilatation, after appropriate vessel preparation
  • Arm 2, or the control group, will be treated with the Lutonix® 035 drug-coated balloon catheter as indicated for improving luminal diameter

The study is 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.

This is a randomized, multi-center, prospective, adaptive-design study to show sufficient safety and effectiveness of the Chocolate Touch® for use in superficial femoral or popliteal arteries, compared to the Lutonix® DCB catheter. The study is designed to further evaluate superiority for both objectives.

The experimental test group will be treated with the Chocolate Touch™ Paclitaxel coated PTA balloon catheter as indicated for balloon dilatation, after appropriate vessel preparation as needed, of lesions in native superficial femoral or popliteal arteries up to 15cm in length that are appropriate for angioplasty with balloon diameters from 3.5mm to 6.0mm.

The comparator or control group will be treated with Lutonix® 035 drug-coated balloon catheter as indicated for improving luminal diameter for the treatment of obstructive de novo or non-stented restenotic lesions (≤ 15 cm in length) in native femoropopliteal arteries having reference vessel diameters of 4 mm to 6 mm.

Inclusion Snapshot

Must have been diagnosed with intermittent claudication of peripheral valves and/or ischemia and be willing to undergo balloon catheterization

Contact Information

Lankenau Institute for Medical Research trial

Physician Investigator(s)

Study Locations