Comparison of a Lithotripsy vs Standard Preparation Followed by Stenting With Supera Stent in Femoropopliteal Lesions

Официальное название

Performance of the Shockwave Medical Peripheral Lithotripsy System vs Standard Balloon Angioplasty for Lesion Preparation Prior to Supera Stent Implantation in the Treatment of Symptomatic Severely Calcified Femoropopliteal Lesions in PAD

Обзор

This study is an investigator-initiated, prospective, single-center, 1:1 randomized pilot study. The trial evaluates the safety and efficacy of intravascular lithotripsy in comparison to standard lesion preparation using standard and/or high-pressure balloon angioplasty in patients with femoropopliteal artery disease. All patients will receive subsequent Supera stent implantation at the operator's discretion. Additional standard nitinol bare metal stent (BMS), drug-eluting stent or covered stent implantation is at the operator's discretion. Patients will be stratified for total occlusions.

Подробное описание

All enrolled subjects will be followed up through 60 months. At 6, 12, 24, 36 MFU after index procedure the incidence of restenosis will be assessed by DUS.

Вмешательства

• Процедура Intravascular lithotripsy
  Lesion preparation with Shockwave Medical Peripheral Lithotripsy System
• Процедура Standard lesion preparation
  Lesion preparation with Standard and/or High-Pressure Balloon Angioplasty

Первичные конечные точки

• Primary efficacy [Срок оценки: During the Procedure]
• Rate of primary outcome events [Срок оценки: 12 month]

Вторичные конечные точки (12)

• Rate of vessel rupture [Срок оценки: During the Procedure]
• Need of additional stent implantation [Срок оценки: During the Procedure]
• Procedure Time (min) [Срок оценки: During the Procedure]
• Fluoroscopy Duration (min) [Срок оценки: During the Procedure]
• Radiation dose area product [Срок оценки: During the Procedure]
• Additional need of intra-procedural pain medication [Срок оценки: During the Procedure]
• Perception of procedural pain evaluated using a numerical rating scale from 0 (no pain) to 10 (severest pain) [Срок оценки: During the Procedure]
• Rate of any dissections after lesion preparation and in the final angiogram [Срок оценки: During the Procedure]
• Rate of primary patency [Срок оценки: 6, 12, 24 and 36 months]
• Rate of Duplex-defined binary restenosis (PVR >2.4) of the target lesion [Срок оценки: post-procedure until discharge from hospital (up to 48 hours) and at 6, 12, 24 and 36 months or at any time of re-intervention]
• Rate of Clinically-driven Target lesion revascularization [Срок оценки: 30 days, 6, 12, 24, 36, 48 and 60 months]
• Rate of Freedom from Major Adverse Event (defined as death, Target lesion revascularization, Target vessel revascularization and target limb major amputation) [Срок оценки: 30 days, 6, 12, 24, 36, 48 and 60 months]

Критерии участия

Критерии включения

• Subject age ≥ 18
• Subject has been informed of the nature of the study, agrees to participate, and has signed a Medical Ethics Committee approved inform consent form
• Subject understands the duration of the study, agrees to attend follow-up visits, and agrees to complete the required testing
• Rutherford Classification 2-5
• Subject has a de novo or restenotic lesion in SFA and/or PPA not exceeding the medial femoral epicondyle with ≥ 70% stenosis documented angiographically
• No previous stent in the target lesion, if target vessel was previously stented the stent should be at least 3cm apart
• Target lesion length is ≥ 10cm, no maximum lesion length limit
• Severe calcification on fluoroscopy defined by PACSS Grade 4: 1) bilateral calcification and 2) extending ≥50mm in length
• Multiple lesions with max. 3cm healthy vessel segment in between lesions can be considered at the discretion of the operator as one lesion
• Reference vessel diameter (RVD) ≥ 4 mm and ≤ 6.5 mm by visual estimation
• Patency of at least one infrapopliteal artery to the ankle (< 50% diameter stenosis) in continuity with the native femoropopliteal artery
• A guidewire has successfully traversed the target treatment segment (both intraluminal and subintimal crossing allowed)

Критерии исключения

• Failure to successfully cross the target lesion
• Presence of fresh thrombus in the lesion
• Presence of aneurysm in the target vessel/s
• Presence of a stent in the target lesion, at least 3cm from any previously stent in target vessel
• Prior vascular surgery of the target lesion
• Stroke or heart attack within 3 months prior to enrollment
• Enrolled in another investigational drug, device or biologic study that has not reached the primary endpoint
• Life expectancy of less than one year
• Known allergies or sensitivity to heparin, aspirin, other anticoagulant/ antiplatelet therapies or contrast media that cannot be adequately pre-treated prior to index procedure
• Rutherford Classification of 0, 1, or 6
• Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy
• Receiving immunosuppressant therapy
• Pregnant or breast-feeding females
• History of major amputation (defined as amputation above ankle joint) in the same limb as the target lesion

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Германия · 1 центр

• University Clinic Leipzig — Leipzig

Идентификаторы

NCT: NCT06112171 · CIP_23/001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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