NCT01960647Unknown3 期
Phase III FREERIDE STUDY Freeway Randomized Angioplasty Study
适应症
试验速览
- 阶段
- 3 期
- 发起方
- Eurocor GmbH
- 入组人数
- 280
- 试验地点
- 18
- 主要终点
- Rate of clinically driven target lesion revascularization
研究概览
简要总结
The primary objective of this prospective, Randomized, Controlled, Multicentre, Open Study is to investigate the inhibition of restenosis by the Paclitaxel-eluting Percutaneous transluminal angioplasty (PTA) balloon Freeway versus PTA alone in the treatment of de-novo occluded, stenotic or reoccluded, restenotic superficial femoral (SFA) or popliteal arteries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Male or non-pregnant female (> 18 years of age) with symptomatic ischemia, requiring treatment of SFA or PI segment ( 2-5 of Rutherford classification)
- •Single and/or multiple de novo occluded, stenotic or reoccluded, restenotic lesion(s) of > 70% , ≤ 15 cm in total length and vessel diameter ≥ 4mm and ≤ 7mm (by visual estimation).
- •Patient provides a signed informed consent and complies with the follow up visits
- •Successful wire crossing of lesion
- •At least one patent (less than 50% stenosis) tibioperoneal run-off vessel
排除标准
- •Gastrointestinal bleeding or coagulopathy contraindicating use of anti-platelet therapy
- •Known intolerance contraindications to study medications and contrast agents, non-controllable with medication.
- •Patient actively participating in another device or drug study
- •History of hemorrhagic stroke within 3 months
- •Previous or planned surgical or intervention procedure within 30 days of index procedure
- •Significant untreated inflow disease or no normal arterial segment proximal of lesion in which duplex ultrasound velocity ratios can be measured
- •Acute or sub-acute thrombus in target vessel
- •Use of adjunctive therapies (i.e. laser, atherectomy, cryoplasty, scoring/cutting balloon)
- •Patients with in-stent restenosis or prior surgery of the target lesion
- •Patients with abdominal aortic, iliaca or popliteal aneurysm (AAA) with ≥ 4cm diameter
结局指标
主要结局
Rate of clinically driven target lesion revascularization
时间窗: 6 months
次要结局
- Technical success(Baseline)
- Clinical success(Baseline)
- Procedural success(Baseline)
- Ankle Brachial index improvement(6, 12, 24 months)
- Change in Rutherford classification(6, 12, 24 months)
- Rate of minor and major complications(6,12, 24 months)
- Rate of target lesion revascularization(12, 24 months)
- Late lumen loss(6 months)
- Patency rate(6, 12, 24 months)
- Walking improvement(6, 12 ,24 months)
研究者
研究点 (18)
Loading locations...
相似试验
进行中（未招募）
3 期
A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung CancerCarcinoma, Non-Small-Cell LungNCT03456076Hoffmann-La Roche257
进行中（未招募）
3 期
Camrelizumab Combined With Famitinib Malate for Treatment of Recurrent/Metastatic Cervical CancerCervical CancerNCT04906993Jiangsu HengRui Medicine Co., Ltd.443
已完成
3 期
A Study of Atezolizumab Compared With Docetaxel in Non-Small Cell Lung Cancer (NSCLC) After Failure With Platinum-Containing ChemotherapyCarcinoma, Non-Small-Cell LungNCT02813785Hoffmann-La Roche565
招募中
3 期
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)TNBC - Triple-Negative Breast CancerNCT05999149Fudan University424
已完成
3 期
Study Comparing Rovalpituzumab Tesirine Versus Topotecan in Subjects With Advanced or Metastatic Small Cell Lung Cancer With High Levels of Delta-like Protein 3 (DLL3) and Who Have First Disease Progression During or Following Front-line Platinum-based Chemotherapy (TAHOE)Small Cell Lung CancerNCT03061812AbbVie444