Study of Shockwave Intravascular Lithotripsy to Improve Vessel Flexibility in Patients with Severe Calcified Peripheral Arterial Disease of the Legs

What this Trial Is About

Peripheral Arterial Disease PAD causes leg pain during exercise and can lead to chronic wounds due to poor blood supply. This condition is mainly caused by artery narrowing from build-up of fats and calcium, increasing risks especially in people with diabetes, high cholesterol, high blood pressure, obesity, or smoking. The trial investigates how a new treatment, intravascular lithotripsy IVL, affects blood vessel stiffness and function compared to standard balloon angioplasty in patients with heavily calcified leg arteries. Participants will be randomly assigned to receive either IVL followed by a drug-coated balloon DCB or plain old balloon angioplasty POBA plus DCB. The IVL device uses sonic pressure waves to break calcium deposits inside the arteries, aiming to improve vessel flexibility and help widen the artery. Both treatments target leg arteries with severe calcification and are delivered via catheters during minimally invasive procedures. During the study, researchers will measure vessel stiffness and function using ultrasound and other imaging techniques before treatment, then again at 1 day and 30 days after the procedure. They will monitor blood flow, artery diameter changes, procedural success, complications, and need for additional treatments. Participants will have follow-up visits to assess healing and vessel performance over time, helping to understand the benefits and effects of IVL on vascular health.

Distrupt Stiffness Trial