DRKS00011210已完成不适用
A Prospective Study of the Performance of the Bard® LifeStent® 5F Vascular Stent System - REALITY III
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 21 Years 至 one（—）
- 性别
- All
入选标准
- •1. The subject or legal representative has been informed of the nature of the evaluation, agrees to its provisions, and has signed the informed consent form (ICF).
- •2. Subject agrees to comply with the protocol-mandated follow-up procedures and visits.
- •3. The subject is = 21 years of age.
- •4. The subject has lifestyle-limiting claudication to mild tissue loss defined as: Rutherford Category 2-5 (moderate claudication to minor tissue loss).
- •5. The target lesion(s) has angiographic evidence of a hemodynamically relevant stenosis or restenosis =50% or occlusion of the SFA and/or popliteal artery (by visual estimate) and is amenable to PTA and stenting.
- •6. The target vessel reference diameter will be (by visual estimate) appropriate for treatment with available stent diameters of 5.0, 6.0 and 7.0 mm.
- •7. A total of two stents may be used to treat a target lesion. Overlapping is allowed.
- •8. There is angiographic evidence of at least one vessel runoff to the foot (at the level of the malleolus).
排除标准
- •1. The subject is unable or unwilling to provide informed consent or is unable or unwilling to comply with the study follow-up procedure and visits.
- •2. The subject has claudication or critical limb ischemia described as Rutherford Category 0 (asymptomatic), 1 (mild claudication), or 6 (major tissue loss).
- •3. The subject has a known contraindication (including allergic reaction) or sensitivity to nickel, titanium or tantalum.
- •4. The subject has a known allergy of hypersensitivity to contrast media which cannot be adequately pre-medicated.
- •5. The subject has a known uncontrolled blood
- •coagulation/bleeding disorder.
- •6. The subject has concomitant renal failure with a creatinine of >2.5 mg/dL.
- •7. The subject has concomitant hepatic insufficiency, thrombophlebitis, uremia, systemic lupus erythematosus (SLE), or deep vein thrombosis (DVT) at the time of the study procedure.
- •8. The subject is receiving dialysis or immunosuppressive therapy.
- •9. The subject is diagnosed with septicemia at the time of the study procedure.
- •10. The subject is participating in an investigational drug or another investigational device study.
- •11. The subject has another medical condition, which, in the opinion of the investigator, may cause him/her to be noncompliant with the protocol, confound the data interpretation, or is associated with limited life expectancy not sufficient to complete all study procedures.
- •12. The subject has extensive peripheral vascular disease, which, in the opinion of the investigator, precludes safe insertion of an introducer sheath.
- •13. The target lesion is located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion.
- •14. The subject has angiographic evidence of poor inflow, which would be deemed inadequate to support a vascular bypass graft.
- •15. The subject has severe calcification of the target lesion, which prevents inflation of a PTA balloon (pre-dilatation of the target lesion is required).
- •16. The subject has angiographic evidence of large acute thrombus at the target lesion.
- •17. Subjects with a stent previously implanted into the target lesion. A target vessel with a previously placed stent is permitted as long as the subject device(s) will not come into
- •contact with the previously placed stent during treatment of the target lesion.
- •18. Lesion requiring the use of more than two stents.
- •19. Bilateral disease in the native SFA and/or popliteal artery where both limbs meet the inclusion/exclusion criteria and it is planned to treat both limbs within 30 days. Note: One limb
- •may be enrolled in the study, but only if the second limb is planned to be treated after the 30 day follow-up telephone screening has taken place. The limb that may be enrolled has
- •to be the limb with the more severe lesion and the reasons for treating this specific limb will need to be stated in the CRF.
- •20. The subject had a prior vascular intervention within 30 days before, or has an intervention planned for within 30 days after the index procedure. Note: Additional non-target lesions may be treated during the index procedure.
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