CRUSH PAD: Real-world Outcomes Following Use of Shockwave Intravascular Lithotripsy (IVL) Technology in Calcified Common Femoral Lesions

Официальное название

CTA_IIT_CRUSH PAD: Real-world Outcomes Following Use of the Shockwave Intravascular Lithotripsy (IVL) Technology in Calcified Common Femoral Lesions

Обзор

The primary goal of the study is to obtain effect size data on the use of Shockwave Intravascular Lithotripsy (IVL) technology in calcified common femoral lesions in patients with peripheral artery disease for a series of endpoints, including target lesion revascularization and health status, to enable future planning of comparative effectiveness research.

Подробное описание

The primary objective of this study is to evaluate the generic health status outcomes and efficacy and safety outcomes following use of the Shockwave Intravascular Lithotripsy (IVL) technology in calcified common femoral lesions in patients with PAD seen in routine clinical practice.

The main testable hypothesis is that the use of IVL is associated with a health status improvement that is equal or higher than the threshold of a minimally clinically important difference on the EQ5D. Preliminarily data will be derived for the primary endpoint target lesion revascularization to enable future planning of larger comparative effectiveness research.

Secondary objectives of the study are to document procedural success following the use of IVL in common femoral lesions, disease stage change, as well as disease-specific health status in the real-world.

Вмешательства

• Устройство Shockwave Intravascular Lithotripsy (IVL)
  Eligible patients with atherosclerotic lesions in the femoral artery who either have claudication or critical limb ischemia will receive endovascular treatment in addition to be treated with Shockwave Intravascular Lithotripsy (IVL) technology.

Первичные конечные точки

• Change in Generic Health Status [Срок оценки: Baseline and 30 days]
• Change in Generic Health Status [Срок оценки: Baseline and 6 months]
• Rate of Procedural Success [Срок оценки: Immediately post procedure]

Вторичные конечные точки (5)

• Number of Patients Free from TLR [Срок оценки: Up to 12 months]
• Number of patients with new-onset MAEs [Срок оценки: Up to 12 months]
• Rate of Periprocedural clinical success [Срок оценки: During admission, before discharge up to 48 hours]
• Change in Clinical Success [Срок оценки: Baseline and 30 days]
• Change in Clinical Success [Срок оценки: Baseline, 6 months and 12 months]

Критерии участия

Критерии включения

• Subjects presenting with claudication or CLI by Rutherford Clinical Category 2, 3, 4, 5, or 6 of the target limbs
• Subject is a suitable candidate for angiography and endovascular intervention per the latest clinical guidelines
• Patient is scheduled to undergo treatment with Shockwave Intravascular Lithotripsy (IVL) technology followed by standard of care treatment with DCB, BMS, DES at the physician's discretion.

Angiographic Inclusion Criteria

• Target lesion that is located in a native, de novo common femoral artery
• Target lesion reference vessel diameter is between 4.0mm and 7.0mm by visual estimate.
• Target lesion is ≥70% stenosis by investigator via visual estimate.
• Target lesion length is ≤50mm for lesions 70-99% stenosed. Target lesion can be all or part of the 50mm treated zone.
• Chronic total occlusion, lesion length is ≤50mm of the total ≤50 mm target lesion.
• Calcification is at least moderate defined as presence of fluoroscopic evidence of calcification: 1) on parallel sides of the vessel and 2) extending > 50% the length of the lesion if lesion is ≥50mm in length; or extending for minimum of 20mm if lesion is <50mm in length.

Критерии исключения

• Subjects with any medical condition that would make him/her an inappropriate candidate for treatment with Shockwave Medical Peripheral Lithoplasty® System as per Instructions for Use (IFU) or investigator's opinion.
• Subject is already enrolled in other investigational (interventional) studies that would interfere with study endpoints.
• Cognitive impairment as documented in medical records
• Not speaking English or Spanish
• Currently a prisoner
• Pregnancy or nursing
• Estimated survival less than 12 months at the time of screening
• Prior history of CFA endarterectomy

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 2 центра

• Yale New Haven Health — New Haven
• The Miriam Hospital — Providence

Идентификаторы

NCT: NCT05145478 · 2000031113

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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