Self-expanding Nitinol Stents of High vs. Low Chronic Outward Force in De-novo Femoropopliteal Occlusive Arterial Lesions
试验速览
- 阶段
- 不适用
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Amount of in-stent restenosis
研究概览
简要总结
The objective of the BIOFLEX-COF trial is to investigate differences in formation of intimal hyperplasia at one and two years after implantation of nitinol-stents with high vs. low COF in de-novo femoropopliteal occlusive lesions in patients with symptomatic peripheral arterial disease.
The BIOFLEX-COF trial is a prospective, randomized controlled trial. 80 subjects will be enrolled and randomly assigned to either a high COF group (LifeStent Vascular Stent) or low COF group (Pulsar).
详细描述
Self-expanding nitinol stents must be oversized at least by a minimal amount to ensure contact with the vessel wall and prevent migration. Once the stent is deployed it exerts a continuous force upon the vascular wall, termed chronic outward force (COF). Data about COF and neointimal hyperplasia in humans are currently lacking. Some animal studies, though, found a markedly increased neointimal hyperplasia in stents with high oversizing and thus high COF. The objective of the BIOFLEX-COF trial is to investigate differences in formation of intimal hyperplasia at one and two years after implantation of nitinol-stents with high vs. low COF in de-novo femoropopliteal occlusive lesions in patients with symptomatic peripheral arterial disease.
The BIOFLEX-COF trial is a prospective, randomized controlled trial. 80 subjects will be enrolled and randomly assigned to either a high COF group (LifeStent Vascular Stent) or low COF group (Pulsar). Diameter of implanted stents will be measured at every two millimetres along the stent axis on DICOM images of the respective completion angiography using image processing software.
The scheduled time for recruitment is 2 years. There will be two follow-up evaluations at 12 and 24 months.
Primary endpoint is the amount of in-stent neointima at one year, assessed by contrast-enhanced CT angiography (CTA). Secondary objectives are the amount of in-stent neointima at two years, device- and procedure-related adverse events and target lesion revascularisation (TLR) rate.
In the control examinations stent diameter and true lumen diameter will be measured on DICOM images every two millimetres along the stent axis to quantify the relative amount of in-stent restenosis.
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
- •Patient related:
- •Subject (or their legal guardian) has read, understood and provided written informed consent, which has been reviewed and approved by the Institutional Review Board.
- •At least 18 years of age.
- •Male, infertile female or female participants of child bearing potential practicing an acceptable method of birth control with a negative pregnancy test within 7-days prior to study procedure.
- •Projected life expectancy of greater than two years.
- •The ability to comply with protocol follow-up requirements and required testing.
- •Lifestyle-limiting claudication or CLI (meeting angiographic entry criteria) affecting a lower extremity (Rutherford stages 2-5). Patients with Rutherford stage 2 are only eligible after unsuccessful conventional and/or medicamentous therapy.
- •Resting ankle-brachial index (ABI) ≤ 0.8 in the study limb.
- •Inflow lesion - if present - has been treated successfully (inflow treatment in same procedure permissible)
- •Angiographic and Lesion Requirements (assessed intraoperatively):
- •TASC A-D lesions from stenoses /occlusions ≤ 35cm.
- •Popliteal artery is patent 5 cm proximal to the radiographic knee joint line.
- •Reference diameter of 4.0 - 7.0 mm in proximal and distal treatment segments within the SFA.
- •Patent SFA orifice (the proximal 5 mm after femoral bifurcation).
- •At least one patent (<50% stenotic) inflow vessel present, proven angiographically. Study eligibility is given when inflow lesion has been treated successfully (inflow treatment in same procedure permissible). Successful treatment of inflow lesion is defined as <50% stenosis without death or severe vascular complication.
- •At least one patent (<50% stenotic)tibial artery runoff to the ankle present, proven angiographically. Study eligibility is given when runoff vessel lesion has been treated successfully (inflow treatment in same procedure permissible). Successful treatment of inflow lesion is defined as <50% stenosis without death or severe vascular complication.Guidewire has successfully traversed lesion and is within the true lumen of the distal vessel.
排除标准
- •Pregnant and/or breast-feeding women.
- •Lesion length > 35 cm.
- •Flow-limiting occlusive disease of inflow and / or outflow arteries that cannot be treated sufficiently.
- •Previous stenting or femoral bypass surgery in the target vessel.
- •Clinical relevant aneurysmatic disease of the abdominal aorta, ipsilateral femoral arteries or arteries of the knee.
- •Rutherford stage 0, 1 or 6
- •Non-atherosclerotic disease resulting in occlusion (e.g., embolism, Buerger's disease, vasculitis).
- •Septicaemia.
- •Ischemic stroke within the last three months.
- •Any previously known coagulation disorder, including hypercoagulability
- •Morbid obesity or operative scarring that precludes percutaneous approach (physician's discretion).
- •Contraindication to anticoagulation or antiplatelet therapy.
- •Known allergy to medication or contrast media used in this trial, if pre-treatment is not possible (physician's discretion).
- •Known allergies to stent components (especially Nickel).
- •Severe calcification of the target lesion.
- •Current participation in another clinical research trial, that has not reached its primary endpoint.
- •The patient is institutionalized based on a legal verdict.
结局指标
主要结局
Amount of in-stent restenosis
时间窗: one and two years post-procedure
Mean amount of in-stent restenosis in percent along the stent axis at one and two years post-procedure.
次要结局
- Adverse Events ISO 14155:2011(within two years post-procedure)
- Target lesion revascularisation (TLR)(within two years post-procedure)
研究者
Alexander Wressnegger
Dr.med.univ.
Medical University of Vienna