NL-OMON55275招募中不适用
A randomized controlled trial evaluating the safety and efficacy of the endovascular treatment of subjects with stenotic or restenotic lesions of the common femoral artery with the Supera Vascular Mimetic Implant compared to surgical Common Femoral Artery Endarterectomy - SUPERSURG RCT
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- ID3 Medical
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Clinical inclusion criteria:
- •CI1. Patient is >=18 years old
- •CI2. Patient presenting a score from 2 to 4 following Rutherford classification
- •CI3. Patient is willing to comply with specified follow-up evaluations at the
- •specified times
- •CI4. Patient understands the nature of the procedure and provides written
- •informed consent, prior to enrolment in the study
- •CI5. Patient has a life expectancy of at least 12 months
- •CI6. Prior to enrolment, the guidewire has crossed the target lesion in the
- •endovascular arm. In the surgical arm, the CFE needs to be performed with
- •primary suture or patch implantation.
- •Angiographic inclusion criteria
- •AI1. De novo stenotic or restenotic (post-PTA) lesions (<100%) located in the
- •common femoral artery, suitable for both endovascular therapy and endarterectomy
- •AI2. Target lesion is located within the native CFA: localized between 1cm
- •proximal to the origin of the circumflex iliac artery and the proximal (2cm)
- •superficial femoral artery and deep femoral artery (2cm) (Azéma type 2 and 3
- •AI3. There is angiographic evidence of a patent deep femoral artery and/or
- •superficial femoral artery
- •AI4. The target lesion has angiographic evidence of >50% stenosis. Occlusions
- •are not allowed
排除标准
- •Clinical exclusion criteria
- •CE1. Presence of another stent in the target vessel that was placed during a
- •previous procedure
- •CE2. Previous open surgery in the ipsilateral groin
- •CE3. Patients contraindicated for antiplatelet therapy, anticoagulants or
- •thrombolytics
- •CE4. Patients who exhibit persistent acute intraluminal thrombus at the target
- •lesion site
- •CE5. Patients with known hypersensitivity to nickel-titanium and heparin,
- •including those patients who have had a previous incidence of heparin-induced
- •thrombocytopenia (HIT) type II
- •CE6. Known allergy to contrast media that cannot be adequately pre-medicated
- •prior to study procedure
- •CE7. Patients with uncorrected bleeding disorders
- •CE8. Female patients with child bearing potential not taking adequate
- •contraceptives or currently breastfeeding
- •CE9. Ipsilateral inflow (aorto-iliac) artery treatment before target lesion
- •treatment with a residual stenosis >30%
- •CE10. Use of thrombectomy, atherectomy or laser device during procedure
- •CE11. Any patient considered to be hemodynamically unstable at onset of
- •CE12. Severe medical comorbidities (untreated CAD/CHF, severe COPD, metastatic
- •malignancy, dementia, etc.) or other medical condition that would prelude non
- •compliance with the study protocol or 1-year life expectancy
- •CE13. Major distal amputation (above the ankle) in the study limb or non-study
- •Angiographic exclusion criteria
- •AE1. Target lesion involves an (pseudo-)aneurysm or is adjacent to an
- •(pseudo-)aneurysm (within 5mm)
- •AE2. Iliac inflow disease requiring treatment, unless the iliac artery disease
- •is successfully treated first during the index procedure. Success is defined as
- •<=30% residual diameter stenosis without death or major complications
- •AE3. Presence of an aortic, iliac or femoral artificial graft
- •AE4. Occlusion in the target lesion
- •AE5. Presence of an interposition graft with/without profunda reimplantation
研究者
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