NCT05662618尚未招募不适用
Prospective, Multicenter, Randomized Controlled Clinical Trial to Verify the Efficacy and Safety of Rapamycin Coated Peripheral Balloon Catheter in the Treatment of Femoral Popliteal Artery Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 276
- 试验地点
- 1
- 主要终点
- primary patency rate, PPR.
研究概览
简要总结
A prospective randomized trial to validate the efficacy and safety of rapamycin coated peripheral balloon catheter in the treatment of femoral popliteal artery disease.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with arteriosclerosis obliterans of lower extremities, and Rutherford's rating is 2-
- •Patients with severe stenosis (≥ 70%) or occlusion of superficial femoral artery and/or proximal popliteal artery (within P1 stage)
- •Patients with total length of target lesion ≤ 20cm and length of occluded segment ≤ 15cm (the distance between two segments of lesions less than 2cm is considered as the same lesion)
- •Those who agree to participate in this clinical trial and sign the informed consent form Exclusion criteria：
- •This operation is planned to intervene patients with bilateral lower limbs.
- •Patients whose guide wire fails to pass through the target lesion.
- •Patients whose target lesion is in stent restenosis (ISR).
- •≥ 2 lesions need to be treated in the target vessel (if the distance between two lesions is less than 2cm, it is considered as the same lesion).
- •Patients with target lesions requiring rotary resection/laser therapy/thrombus aspiration for this treatment.
- •Patients with ipsilateral iliac artery inflow tract lesions that cannot be successfully treated (i.e. residual stenosis ≥ 30% after treatment).
- •There is less than one unobstructed blood vessel under the knee of the target limb before operation (unobstructed is defined as visual stenosis<50%).
- •Residual stenosis ≥ 30% after pre expansion of target lesion or severe (≥ Grade D) flow limiting dissection.
- •Patients with obviously abnormal renal function (creatinine > 2.5mg/dL or 220umol/L) or undergoing dialysis.
- •Patients with severe liver dysfunction who are judged by the researcher to be unsuitable for surgery.
- •Patients with severe coagulation dysfunction or uncontrolled severe infection who are not suitable for surgery.
- •Patients who have performed distal amputation (above metatarsal) on the affected or opposite limb in the past.
- •Patients who received local or systemic thrombolytic therapy within 48 hours before surgery.
- •Patients receiving vascular interventional therapy or surgical treatment on target limb within 30 days before operation.
- •Patients known to be allergic to aspirin, clopidogrel, paclitaxel and rapamycin.
- •Pregnant or lactating women and patients with family planning during the study
- •Patients who are participating in clinical trials of other drugs or medical devices but are not included in the group.
- •Patients with life expectancy less than 12 months
- •Patients not suitable for this study.
排除标准
- 未提供
结局指标
主要结局
primary patency rate, PPR.
时间窗: 12months
It is defined as:Primary patency of target lesion: the target lesion is patency (systolic peak blood flow ratio\<2.4) and there is no clinically driven target lesion revascularization (TLR) by Doppler ultrasound.
次要结局
- Device success rate(The day of operation.)
- Operation success rate(1DAY)
- Target Lesion Revascularization incidence.(12 months after operation.)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Topical Rapamycin Therapy to Alleviate Cutaneous Manifestations of Tuberous Sclerosis Complex (TSC) and Neurofibromatosis I (NF1)Tuberous SclerosisNeurofibromatosesNeurofibromaAngiofibromaNCT01031901The University of Texas Health Science Center, Houston52
Unknown
早期 1 期
Rapamycin Plus Methylprednisolone Versus Methylprednisolone Alone in Active, Moderate-to-severe Graves' Orbitopathy.Graves OphthalmopathyNCT05532072First Affiliated Hospital Xi'an Jiaotong University140
尚未招募
不适用
Rapamycin Coated Balloon Dilation Catheter for Arteriovenous FistulaPeripheral Arterial DiseaseNCT06029569Shanghai Bomaian Medical Technology Co., Ltd256
已完成
4 期
Rapamycin In Angiomyolipomas In Patients With Tuberous SclerosisAngiomyolipomaNCT01217125Fundacio Puigvert18
Unknown
不适用
A Trail of Drug-coated Balloon Treating Below The Knee Arterial DiseasesPeripheral Artery DiseaseNCT05415995Zhejiang Zylox Medical Device Co., Ltd.202