Distrupt Stiffness Trial

Typical symptoms of PAD include exercise-induced pain in the legs (known as intermittent claudication), which can significantly limit pain-free walking. In more advanced stages, pain may also occur at rest. Additionally, the development of chronic, hard-to-heal wounds-especially on the feet and toes-is possible. These wound healing impairments are caused by the insufficient supply of oxygen and nutrients to the affected tissues. The underlying cause of PAD is usually atherosclerosis, a pathological change in the vessel walls due to the accumulation of fats, calcium, and connective tissue. These deposits lead to stiffening and narrowing of the arteries, severely restricting blood flow. Major risk factors for the development of PAD include widespread chronic conditions such as diabetes mellitus, hyperlipidemia (elevated blood lipid levels, e.g., cholesterol), arterial hypertension (high blood pressure), obesity, and tobacco use. Various therapeutic options are available for the treatment of PAD. In addition to conservative therapy (such as supervised exercise training, pharmacological blood thinning, and risk factor management), interventional, minimally invasive treatment using catheter-based techniques is frequently employed. In such procedures, a thin catheter is guided through the vascular system to the affected area of the leg artery. Depending on the type and extent of the arterial narrowing or calcification, one of the following techniques may be applied: Balloon angioplasty: Dilation of the vessel using an inflatable balloon. Lithoplasty: Application of shockwaves to break down calcifications in the arterial wall.

NCT Number	NCT07130526
Lead Sponsor	University Hospital, Essen Collaborators: Shockwave Medical, Inc.
Conditions	PAD - Peripheral Arterial Disease, PAD
Enrollment	40 participants
Start Date	2025-07-01
Primary Completion	2026-04-20 (estimated)
Study Completion	2026-06-20 (estimated)
Updated on ClinicalTrials.gov	2025-08-19