NL-OMON51143尚未招募不适用
Prospective, Multicenter, Post-market, Single Arm study to confirmthe performance of the RenzanTM Peripheral Stent System in treating Superficial Femoral and/or Popliteal artery disease - PRIZER
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Terumo
- 入组人数
- 10
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
- •1. Age >=18 years.
- •2. Subject must provide written informed consent prior to the treatment of the
- •target lesion.
- •3. Subject must be willing to comply with the specified follow-up evaluation
- •4. Subject with Rutherford-Becker clinical classification category 2 to 5, with
- •a resting ankle-brachial index (ABI) <= 0.9.
- •5. A superficial femoral and/or popliteal artery lesion with > 50% stenosis or
- •total occlusion.
- •6. Stenotic or occluded lesion(s) within the same vessel (one long or multiple
- •serial lesions treatable with one stent) >= 40 mm and <= 140 mm in length, with
- •reference vessel diameter (RVD) >= 4.0 mm and <= 7.0 mm by visual assessment.
- •7. A patent inflow artery free from significant lesion (>=50% stenosis) as
- •confirmed by angiography (treatment of target lesion acceptable after
- •successful treatment of ipsilateral iliac lesions); Successful ipsilateral
- •iliac artery treatment is defined as attainment of residual diameter stenosis
- •<=30% without death or major vascular complication, either with PTA or stenting.
- •8. The target lesion(s) can be successfully crossed with a guide wire and
- •dilated up to 1:1 to healthy vessel (as per operator*s assessment).
- •9. At least one patent native outflow artery (anterior or posterior tibial or
- •peroneal) to the foot, free from significant (>=50%) stenosis (as confirmed by
- •angiography), that has not previously been revascularized. The remaining
- •outflow arteries requiring treatment during the same procedure may be treated
- •only with uncoated devices and before the target lesion.
- •10. A subject with bilateral obstructive SFA disease is eligible for enrollment
- •into the study. If a subject with bilateral disease is enrolled, the target
- •limb will be selected at the Investigator's discretion, who may use the
- •criteria of lesion length, percent stenosis, and/or calcification content. The
- •contra-lateral procedure should not be done until at least 30 days after the
- •index procedure; however, if contralateral treatment is performed prior to
- •treatment of the target lesion it should be performed at least 1 day before the
- •index procedure with uncoated devices only.
- •11. The subject is eligible for surgical repair, if necessary.
排除标准
- •1. Subject has Rutherford-Becker classification category 6.
- •2. Treatment of lesions requiring the use of adjunctive debulking devices.
- •3. The use of drug-coated balloons at any step of the procedure.
- •4. Required stent placement via a popliteal approach.
- •5. Required stent placement across or within 0.5 cm of the superficial and
- •profunda femoral artery bifurcation.
- •6. In-stent restenosis treatment or any other procedure which requires
- •stent-in-stent placement to obtain patency.
- •7. Restenotic lesion that had previously been treated by atherectomy, laser or
- •cryoplasty within 3 months of the index procedure.
- •8. Lesion with the length that would require stent overlap.
- •9. Required stent placement within 1 cm of a previously deployed stent.
- •10. Any significant vessel tortuosity or other parameters prohibiting access to
- •the lesion and/or preventing the stent delivery.
- •11. Subject with coronary intervention performed less than 90 days prior to or
- •planned within 30 days after the treatment of the target lesion.
- •12. Known allergies or intolerance to nitinol (nickel titanium), or contrast
- •13. Any contraindication or known unresponsiveness to dual antiplatelet therapy
- •(DAPT) or anticoagulation therapy.
- •14. Presence of acute thrombus prior to crossing the lesion.
- •15. Thrombolysis of the target vessel within 72 hours prior to the index
- •procedure, where complete resolution of the thrombus was not achieved.
- •16. Thrombophlebitis or deep venous thrombus, within the previous 30 days.
- •17. Subject receiving dialysis within the previous 30 days.
- •18. Stroke within the previous 90 days.
- •19. Known or suspected active infection at the time of the procedure.
- •20. Subject is pregnant or of childbearing potential
- •21. Subject has life expectancy of less than 1 year.
- •22. Subject is participating in an investigational study that has not reached
- •primary endpoint at the time of study screening.
- •23. Treatment of outflow arteries (anterior or posterior tibial or peroneal)
- •following target lesion treatment (unless bailout).
研究者
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