Revascularization With Modification Using Definitive IVL and Serration Remodeling for Optimal Lumen

Официальное название

REMODEL I: Revascularization With Modification Using Definitive IVL and Serration Remodeling for Optimal Lumen

Обзор

The objective of this first-in-human study is to assess the safety and effectiveness of the Serranator Sonic Intravascular Lithotripsy (IVL) System™ for the treatment of peripheral artery disease.

Вмешательства

• Устройство Serranator Sonic Intravascular Lithotripsy (IVL) System
  Serration remodeling balloon angioplasty with Intravascular Lithotripsy of the superficial femoral and popliteal arteries for Cohort A: Above-the-Knee; treatment of the infrapopliteal and inframalleolar arteries for Cohort B: Below-the-Knee.

Первичные конечные точки

• Primary Safety: Major Adverse Events [Срок оценки: 30 Days]
• Primary Effectiveness: Procedural Success [Срок оценки: Procedure]

Вторичные конечные точки (9)

• Freedom from Major Adverse Events at 6 months [Срок оценки: 6 months]
• Freedom from Major Adverse Events at 12 months [Срок оценки: 12 months]
• Procedural success of ≤30% residual stenosis of the target lesion [Срок оценки: Procedure]
• Patency rates of target lesion by duplex ultrasound [Срок оценки: 30 Days, 6 Months, and 12 Months]
• Freedom from clinically-driven target lesion revascularization [Срок оценки: 30 Days, 6 Months, and 12 Months]
• Change in Ankle-Brachial Index/Toe-Brachial Index [Срок оценки: 30 Days, 6 Months, and 12 Months]
• Change in Rutherford Category [Срок оценки: 30 Days, 6 Months, and 12 Months]
• Change in Walking Impairment Questionnaire score [Срок оценки: 30 Days, 6 Months, and 12 Months]
• Change in EuroQol-5D-3L [Срок оценки: 30 Days, 6 Months, and 12 Months]

Критерии участия

\*Inclusion Criteria for Cohort A: ATK arm of the study:

Clinical:

• Subject is ≥ 18 years of age
• Target limb is Rutherford Clinical Category 2, 3 or 4
• Resting ABI of ≤0.90, or TBI ≤0.70 of the target limb

Angiographic:

• Subject must have a de novo target lesion in a native superficial femoral artery (SFA) or popliteal artery
• Reference vessel diameter (RVD) between 4.0 and 8.0mm
• Target lesion must have a diameter stenosis of ≥70%
• Lesion calcification is at least moderate
• Total planned target lesion length must be ≤150mm
• Chronic total occlusion lesion length is ≤100mm
• Subject has at least one patent tibial vessel on the target limb with runoff to the foot

• Exclusion Criteria for Cohort A: ATK arm of the study:

Clinical:

• Rutherford Clinical Categories 0, 1, 5 and 6
• Subject with known pregnancy or is nursing
• Subject has acute or chronic renal disease, defined as serum creatinine of >2.5 mg/dL or >220 µmol/L or on dialysis

Angiographic:

• Target lesions >150mm by visual estimation
• Chronic total occlusions > 100mm by visual estimation
• No or mild calcium present in the target lesion

• Inclusion Criteria for Cohort B: BTK arm of the study:

Clinical:

• Age of subject is ≥18
• Rutherford Clinical Category 2 - 5 (with tissue loss limited to the digits and no evidence of infection)

Angiographic:

• Single or two target lesion(s) located in a de novo artery distal to the trifurcation vessels
• Target vessel reference diameter is between 2.5mm and 4.0 mm
• Target lesion with diameter stenosis ≥50%
• Target lesion is ≤150mm in length
• Subject has at least one patent tibial vessel (>50%) with run-off to the foot.
• Calcification is at least moderate

• Exclusion Criteria for Cohort B: BTK arm of the study:

Clinical:

• Rutherford Clinical Category 0,1 or 6
• Gangrene of the lower extremity
• Patient is pregnant or nursing

Angiographic:

• Target lesion is within only lower extremity vessel with < 50% stenosis
• Target lesion length exceeds 150mm
• Patient has chronic total occlusion of target lesion

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07575568 · CSP-1179

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗