femoral-popliteal artery occlusive disease
Conditions
Interventions
Test group:Using microneedle injection balloon to dilate femoropopliteal artery stenotic lesions and to inject paclitaxel (albumin-bound)
Sponsors
Xiangyang Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1.Male or female,age =18 years and =85 years; 2.Documented diagnosis of peripheral arterial disease in the superficial femoral artery and/or proximal popliteal artery above the knee, Rutherford Clinical Category 2-5, with lesions located in the superficial femoral artery and profunda femoral artery at least 1 cm from the bifurcation of the common femoral artery (CFA) (proximal anatomical landmark) to the distal P1 segment of the popliteal artery (distal anatomical landmark) 3.Vessel diameters =4mm and =8mm; 4.Patient are able to walk without assistive equipment (e.g.walking aid, cane); 5.CT angiography shows evidence of adequate blood flow in the distal foot (patency of at least one native calf vessel [posterior tibial artery, anterior tibial artery, or peroneal artery], patency defined as =50% diameter stenosis); 6.Voluntarily sign the informed consent form; 7.Understand and accept the duration of the study, and be able and willing to comply with the subject requirements in the protocol, including follow-up and examination; 8. Life expectancy >6 months.
Exclusion criteria
Exclusion criteria: 1.Stroke or symptomatic myocardial infarction within 3 months before procedure; 2.Patients with severe renal insufficiency(Creatine >2.5 mg/dL); 3.Severe heart failure unable control by medications; 4.Acute lower limb arterial ischemia; 5.Known allergies to heparin, aspirin, clopidogrel or contrast media; 6.Those who have participated in clinical trials of other drugs or devices in the past three months; 7.Target lesion is in-stent restenosis or history of bypass surgery; 8.Patients with any other conditions in the opinion of the investigator,is inappropriate for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Late lumen loss at 6 months post procedure(LLL);Rate of participants free from complex adverse events at 1 month post procedure; | — |
Secondary
| Measure | Time frame |
|---|---|
| Primary patency rate (at 3 and 6 months post procedure);Percentage of participants undergoing clinically driven target-lesion revascularization ( at 1, 3, and 6 months post procedure);Percentage of participants with treated lesion restenosis ( at 1, 3, and 6 months post procedure); Participants with target limb amputation ( at 1, 3, and 6 months post procedure);Device success rate (intraoperative);Procedure success rate (intraoperative);Clinical success rate (before discharge);Percentage of participants with sustained clinical improvement ( at 6 months post procedure);Improvement in Rutherford Classification Scores compare to baseline (before discharge, at 1, 3, 6 months post procedure);Improvement in Resting Ankle Brachial Index (ABI) compare to baseline (before discharge, at 1, 3, 6 months post procedure) ;Improvement in Walking Impairment Questionnaire (WIQ) compare to baseline (before discharge, at 1, 3, 6 months post procedure) ;Improvement in 6-minute walk test (6MWT) compare to baseline (before discharge, at 1, 3, 6 months post procedure) ;Improvement in EuroQol-5D (EQ-5D) compare to baseline (before discharge, at 1, 3, 6 months post procedure) ;Device performance evaluation (on the day of procedure); | — |
Countries
China
Contacts
Public ContactDejie Chen
XIANGYANG CENTARL HOSPITAL
Outcome results
None listed