Supera Treatment Registry Observing Neointimal Growth
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 200
- 试验地点
- 8
- 主要终点
- Six-minute Walking Distance
研究概览
简要总结
Long-term, observational, prospective, multicenter registry following patients who have been implanted with the SUPERA Interwoven Self-Expanding Nitinol Stent for treating stenosis in the superficial femoral and/or femoropopliteal arteries.
详细描述
This registry follows up to 200 patients for at least 5 years.
The STRONG Data Registry will follow patients under real world conditions, evaluating restenosis rates, periprocedural/postprocedural complications, patency, target lesion revascularization, walking distance, stent fractures, and adverse events/serious adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 未提供
排除标准
- •Patient or legal guardian understands registry procedures and has voluntarily signed an informed consent in accordance with institutional and local regulatory policies. (Note: Retrospective data may be collected and entered into the EDC system after a fully executed informed consent has been provided).
- •Rutherford-Becker classification 2 through 5 only
- •Patient is at least 18 years of age and of legal age of consent.
- •Patient must be willing to participate in the registry for at least 5 years.
- •(Angiographic)
- •Target lesion is a single de novo or restenotic (outside a stent) SFA or Popliteal artery lesion ≥ 1 cm from origin of another stent; additional lesions may be present., but there is only one target lesion
- •All SFA target lesions are to be located with the proximal point at least 2 cm below the origin of the profunda femoris artery.
- •All Popliteal Artery target lesions are to be located with the most distal point at least 1 cm proximal to the bifurcation of the anterior tibial artery and the tibioperoneal trunk.
- •Target lesion length 1-20 cm (visual estimate)
- •Target lesion stenosis ≥50% (visual estimate)
- •Popliteal artery patent if the lesion is in the SFA
- •SFA patent if the lesion is in the popliteal artery
- •At least one widely patent (< 50% stenosis) infrapopliteal artery (for distal run-off)
- •Exclusion Criteria:
- •Evidence of heparin induced thrombocytopenia (HIT), or intravenous tPA, Plavix, Ticlid, or aspirin therapy sensitivities
- •Patient is participating in a clinical study that could confound results
- •Patient is pregnant/breastfeeding at time enrollment or plans to become pregnant during the course of participation in the registry.
- •(Angiographic)
- •Target lesion length > 20 cm
- •Instent restenotic / reoccluded target lesion
- •Acute (≤ 4 weeks) thrombotic occlusion
- •Untreated ipsilateral pelvic stenosis
研究组 & 干预措施
Device SUPERA Stent
SUPERA Interwoven Self-Expanding Nitinol Stent System
干预措施: SUPERA Interwoven self-expanding nitinol stent (Device)
结局指标
主要结局
Six-minute Walking Distance
时间窗: 1 Year
The Six-minute Walking Distance test is an objective method for estimation of walking capacity in patients with Peripheral Arterial Disease (PAD) or claudication.
次要结局
- Rutherford-Becker Clinical Category(30 days)
- Restenosis by Duplex Ultrasound(1 Year)
- Target Lesion Revascularization(1 Year)
- Stent Fracture(1 to 3 Years)
- Number of Participants Experiencing Peri-procedural and Post-procedural Complications(30 days)
- Number of Peri-procedural and Post-procedural Complications(30 days)
- Target Limb Ankle Brachial Index (at Rest)(2 Years)
- Six-minute Walking Distance(2 Years)