Distrupt Stiffness Trial

Recruiting now · Not applicable

Conditions studied: PAD - Peripheral Arterial Disease, PAD

In brief

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.

Key facts

Study ID: NCT07130526
Run by: University Hospital, Essen
People needed: 40
Starts: 2025-07-01
Expected to finish: 2026-06-20
Last updated by the study team: 2025-08-19

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Peripheral artery disease
Severe Calcification PACCS 2,3 and 4
Target lesions in distal EIA, CFA, prox. SFA or PA
Clinical diagnosis of chronic, symptomatic lower limb ischemia as defined by Rutherford 2, 3, 4 and 5
Planed peripheral intervention TASC A-D
Subject must be between 18 and 85 years old
Willing to comply with the specified follow-up evaluation
Written informed consent prior to any study procedures

You may not qualify if…

Target lesions with no optimal visualization in ultrasound
Instent-Restenosis
Thrombolysis within 72 hours prior to the index procedure
Aneurysm formations in the femoral artery or popliteal artery
Concomitant hepatic insufficiency, deep venous thrombus, coagulation disorder or receiving immunosuppressant therapy
Unstable angina pectoris at the time of the enrolment
Recent myocardial infarction or stroke < 30 days prior to the index procedure
Life expectancy less than 12 months
Septicemia at the time of enrolment
Known or suspected active infection at the time of the index procedure, excluding an infection of a lower extremity wound of the target limb
Known or suspected allergies or contraindications to aspirin, clopidogrel or heparin

Where it is running

University of Duisburg-Essen — Essen, Germany (enrolling)
West German Heart and Vascular Center, Clinic for Cardiology and Vascular Medicine, Universtiy Hospital Essen — Essen, North Rhine-Westphalia, Germany

Full record on ClinicalTrials.gov

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