NCT03414515已完成不适用
Endovascular Treatment of Peripheral Artery Disease.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Duomed
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Binary restenosis
研究概览
简要总结
The purpose of this observational study is to evaluate the performance and safety of endovascular treatment with stenting (Optimed Sinus Superflex 635 or Qualimed Pontos-pp) or balloon angioplasty (Cardionovum Legflow or Optimed Nylotrack .035 + .018) according to current practice. The goal of the study will be achieved by assessing binary restenosis with duplex ultrasound, peri- and postoperative complications, technical success, target lesion revascularization, amputation and clinical outcome.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Patient must sign the informed consent form prior to the index-procedure.
- •Patient is older than 18 years.
- •Patient is compliant with the requested follow-up visits at week 6 and month 12 and the treatment regime.
- •Patient suffers from mild to intermittent claudication (Rutherford 1-3) or critical limb ischemia (Rutherford 4-5).
- •Target lesion is an occlusion or diameter stenosis is ≥50% by visual estimate.
- •Target lesion is located in the common and external iliac artery, in the common and superficial femoral artery, popliteal artery and/or the below-the-knee (BTK) arteries (anterior tibial artery, posterior tibial artery or peroneal artery).
排除标准
- •Patients with Rutherford 0 and
- •Patient is pregnant.
- •Patients with estimated Glomerular filtration rate (eGFR) < 30 mL/min/1.73m
- •Patient has an acute thrombus or aneurysm in the target arteries.
- •Patient has a life expectancy of <12 months.
- •Patient has a target lesion that cannot be crossed with a guidewire.
- •Patient suffers from acute limb ischemia defined as any sudden decrease in limb perfusion causing a potential threat to limb viability.
- •Patient has scheduled elective non-vascular procedures within 3 months after index-procedure. Vascular procedures are allowed within 3 months after the index-procedure if it is guaranteed that acetylic salicylic acid and clopidogrel intake is not interrupted.
- •Contraindication for anti-thrombotic therapy (coagulopathy, ...).
- •Patient has a known intolerance to anti-thrombotic medication or contrast agents.
结局指标
主要结局
Binary restenosis
时间窗: at 12 months follow-up
Binary restenosis defined as ≥ 50% re-obstruction of the target lesion will be assessed by duplex ultrasound (peak systolic ratio \>2.4)
次要结局
- Device-related complications(up to 12 months follow-up)
- Secondary sustained clinical improvement(at 12 months follow-up)
- Mortality(up to 12 months follow-up)
- Immediate procedural outcome(during index-procedure)
- Clinical outcome(at 12 months follow-up)
- Target lesion revascularization (TLR)(up to 12 months follow-up)
- Primary sustained clinical improvement(at 12 months follow-up)
- Amputation(up to 12 months follow-up)
研究者
研究点 (1)
Loading locations...
相似试验
终止
不适用
Endovascular Treatment of Peripheral Artery DiseaseIliac Artery DiseaseBelow-the-knee ObstructionFemoropopliteal Occlusive DiseasePeripheral Arterial DiseaseNCT03346577be Medical60
已完成
不适用
Effectiveness of Medical Therapy, Endovascular Therapy, and Surgery for Peripheral Arterial DiseasePeripheral Arterial DiseaseNCT01588067Kaiser Permanente271
已完成
3 期
Endovascular Treatment With or Without Preceding Intravenous Tenecteplase (TNK) in Patients With Late-window acUte Ischemic Stroke Due to Middle Cerebral Artery OcclusionIschemic Stroke, AcuteThrombolysisEndovascular TreatmentNCT06221371Beijing Tiantan Hospital391
招募中
不适用
Vascular Effects Through Sirolimus vs. Paclitaxel DCB ImplantationFlow-mediated DilationDrug Eluting BalloonPeripheral Arterial DiseaseInfrainguinal Peripheral Arterial DiseaseNCT05450042University Hospital, Essen70
已完成
不适用
Vastmanland Myocardial Infarction Study (VaMIS)Peripheral Artery DiseaseDiabetesAcute Myocardial InfarctionNCT01452178Uppsala University1,008