Interventional study for patients diagnosed with moderate or severe peripheral artery disease

Study ID: DISRUPT PAD III

DISRUPT PAD III: Randomized study of the Shockwave Medical Peripheral Lithoplasty® System used in combination with DCB versus standard balloon angioplasty used in combination with DCB to treat moderate and severely calcified femoropopliteal arteries (Disrupt PAD III)

Researchers are testing the safety and effectiveness of the Shockwave Medical Peripheral Lithoplasty® System used in combination with drug-coated balloon (DCB) vs. standard balloon angioplasty used in combination with DCB to treat moderate and severely calcified femoropopliteal arteries (Disrupt PAD III).

The Shockwave Lithoplasty System is a proprietary lithotripsy-enhanced balloon catheter designed to be delivered through the peripheral arterial system of the lower extremities to the site of calcified stenosis. Activating the lithotripsy within the device will generate pulsatile mechanical energy within the target treatment site, disrupt calcium within the lesion and allow subsequent dilation of a peripheral artery stenosis using low balloon pressure. The system consists of a balloon catheter with multiple integrated lithotripsy electrodes, and a generator.

Additionally, an observational study of participants who do not meet the inclusion/exclusion criteria for the randomized study will be conducted. The objective of the observational study is to assess the real-world acute performance of the Shockwave Medical Peripheral Lithoplasty System in the treatment of calcified, stenotic, peripheral arteries.

The purpose of this randomized study is to test the safety and effectiveness of the Shockwave Medical Peripheral Lithoplasty® System used in combination with drug-coated balloon (DCB) vs. standard balloon angioplasty used in combination with DCB to treat moderate and severely calcified femoropopliteal arteries (Disrupt PAD III).

All patients presenting to the institution with known femoropopliteal disease requiring an interventional procedure will be evaluated for eligibility and participation in the randomized study. Eligibility includes compliance with all scheduled study follow-up appointments.

The observational study is a prospective, multi-center, single-arm observational study for subjects who do not meet the inclusion/exclusion criteria of the randomized study.

Subjects will be followed through discharge, 30 days, and six, 12 and 24 months. DUS assessments will be completed at 12 and 24 months.

See clinicaltrials.gov for full list of inclusion and exclusion criteria.

Inclusion Snapshot

Must have been diagnosed with peripheral artery disease and willing to undergo balloon catheter

Contact Information

Lankenau Institute for Medical Research trial

Physician Investigator(s)

Study Locations