NCT07575568尚未招募不适用
REMODEL I: Revascularization With Modification Using Definitive IVL and Serration Remodeling for Optimal Lumen
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •*Inclusion Criteria for Cohort A: ATK arm of the study:
- •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
排除标准
- •for Cohort A: ATK arm of the study:
- •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:
- •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:
- •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
研究者
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