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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Intravascular Lithotripsy (IVL) plus DCB
DeviceThe 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,
POBA plus DCB
DeviceStandard of Care
Treatment groups
Trial outcomes
Primary outcomes
FDC
To determine changes in vessel compliance before and after IVL treatment and after 1 month compared to POBA in symptomatic PAD as determined by fractional diameter change (FDC).
Secondary outcomes
FMD/NMD analysis of the target lesion
• Endothelial function and endothelial independent function as determined by FMD/NMD analysis of the target lesion. FMD represents the percent diameter gain as calculated based on preischemia and postischemia diameter measurements of the femoral artery. NMD represents the diameter change of the femoral artery after nitroglycerine-mediated vasodilation.
PWV
Aortic stiffness determined by pulse wave velocity (PWV)
ABI
Peripheral perfusion determined by ABI (ankle brachial index)
Primary patency (PP)
Primary patency (PP) evaluated by clinical assessment by ultrasound
Sponsors and contacts
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University Hospital, Essen
Lead sponsor
Shockwave Medical, Inc.
Collaborator