Distrupt Stiffness Trial
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Source: NCT07130526, who can take part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- University Hospital, Essen
- Trial code
- NCT07130526
- Record updated
- 19 August 2025
- Original description
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.Read full original descriptionShow less
Trial to Investigate the Shockwave Intravascular Lithotripsy (IVL) on Vascular Compliance in Heavily Calcified Femoropopliteal Disease (PACSS 2-4)
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.
Inclusion: 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.
Exclusion: Thrombolysis within 72 hours prior to the index procedure; Concomitant hepatic insufficiency, deep venous thrombus, coagulation disorder or receiving immunosuppressant therapy; Recent myocardial infarction or stroke < 30 days prior to the index procedure; Unstable angina pectoris at the time of the 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; Target lesions with no optimal visualization in ultrasound; Instent-Restenosis; Aneurysm formations in the femoral artery or popliteal artery; Life expectancy less than 12 months; Septicemia at the time of enrolment.