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โ† Trials
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Distrupt Stiffness Trial

RecruitingNAAges 18 Years - 85 YearsAllUniversity Hospital, Essen
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In plain words

What the trial is, and whether it could suit you

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 b

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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
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What it tests

  • Intravascular Lithotripsy (IVL) plus DCB
  • POBA plus DCB
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Where

2 sites
West German Heart and Vascular Center, Clinic for Cardiology and Vascular Medicine, Universtiy Hospital Essen
Essen, Germany
University of Duisburg-Essen
Essen, Germany
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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