Description

The purpose of this study is to test if a combination of the Lithoplasty® device used with a DCB or a standard balloon angioplasty used with a DCB is more effective to treat moderate and severely calcified femoropopliteal arteries that have significant narrowing and deficient blood flow. The Shockwave Lithoplasty device has been approved by the FDA and EU to treat peripheral artery disease. This device uses a new technology inside the balloon, which is designed to deliver sonic energy (sound) to disrupt the hard, calcified elements of vascular blockages in the arteries. This device has the possibility to enable lower pressure expansion of arteries with calcium. The IN.PACT Admiral DCB is coated with Paclitaxel and Urea, which is intended to prevent the re-narrowing of the artery due to plaque buildup.

Inclusion Criteria:
18 years or older
Rutherford 2, 3 or 4

Exclusion Criteria:
Active infection requiring antibiotic therapy
Allergy to urethane, nylon or silicone
Recent (< 60 days) myocardial infraction
Recent (< 60 days) stroke
Patients with renal failure

Contact

i-Camp Team icamptrials@bcm.eduPhone 1: 713-798-7537
IRB: h-42825

Status

Active

Created

Mar 25, 2019