RECRUITINGINTERVENTIONAL

Distrupt Stiffness Trial

Trial to Investigate the Shockwave Intravascular Lithotripsy (IVL) on Vascular Compliance in Heavily Calcified Femoropopliteal Disease (PACSS 2-4)

About This 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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form prior to any study procedures Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DEVICE

Intravascular Lithotripsy (IVL) plus DCB

The device under investigation is the Peripheral Lithotripsy System (Shockwave Medical, Fremont, California). Miniaturized and arrayed lithotripsy emitters create a localized field effect at the site of the calcium. The Peripheral Lithotripsy System is CE-marked for peripheral arterial disease and for this study, will be used within its indication for use. This included the following: intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral and popliteal arteries. The IVL catheter is delivered across a calcified lesion over an 0.014'' wire and the integrated balloon is expanded to 4atm to facilitate efficient energy transfer. An electrical discharge from the emitters vaporizes the fluid within the balloon, creating a rapidly expanding and collapsing bubble that generates sonic pressure waves. The waves create a localized field effect that travels through soft vascular tissue,

DEVICE

POBA plus DCB

Standard of Care

Locations (2)

West German Heart and Vascular Center, Clinic for Cardiology and Vascular Medicine, Universtiy Hospital Essen

Essen, North Rhine-Westphalia, Germany

University of Duisburg-Essen

Essen, Germany