Stenosis or occlusive lesions of the infrapopliteal artery
Conditions
Interventions
Experimental group:Shanghai Hong Pulse Medical Technology Co., Ltd. developed the below-knee drug balloon dilation catheter
Control group:Subknee drug-coated balloon dilatation catheter developed and manufactured by Beijing Centaur Medical Technology Co.
Sponsors
The First Hospital of Zhongshan University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: ? Age 18-85 years; ? atherosclerotic stenosis or occlusive lesion of the infrapopliteal artery (segment P2 of the popliteal artery to above the ankle); ? occlusion or stenosis of = 70% of the target lesion vessel; ? Rutherford classification of 3-6; ? Visual inspection of the target lesion reference vessel diameter 2.0-4.0 mm ? met prior to randomization grouping, with successful pre-dilation of the target lesion (=50% residual stenosis and no flow-limiting stenosis above grade C) ? Patients or their guardians were able to understand the purpose of the trial, voluntarily participated and signed a written informed consent, and were able to accept follow-up.
Exclusion criteria
Exclusion criteria: ? women who are pregnant or breastfeeding; ? Patients with acute embolism or thrombosis requiring thrombolysis or thrombus retrieval; ? Patients with severe calcification of the target lesion (PACSS score: grade 4); ? patients in whom the guidewire is unable to pass through the lesion ? patients with >50% untreated inflow tract stenosis, or with residual inflow tract stenosis remaining >30% after treatment ? outflow tracts without target lesions below the ankle joint; ? Patients who have had or are planning a major amputation; ? patients whose target lesion is in-stent restenosis ? Patients with a target lesion treated within 6 weeks of prior ? non-atherosclerotic disease resulting in occlusion (e.g. Buerger's disease, vasculitis) ? severe coagulation disorders; ? uncontrollable infections, such as bacteremia or toxemia ? Patients with malignancy and a life expectancy of less than 6 months ? Severe renal abnormalities with serum creatinine 2 times above the upper limit of normal (except in patients on hemodialysis) ? Patients with known allergy or intolerance to heparin, contrast agents, aspirin, clopidogrel, paclitaxel ? Subjects who are participating in another drug or medical device clinical trial and have not completed the primary study endpoint of the study; ? Patients who, in the opinion of the investigator, have poor compliance, are unable to follow the trial protocol, or have other conditions that make them inappropriate for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I patency rate of target lesions at 6 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Device success rate; Technical success rate;Phase I target lesion patency rate (12 months, 24 months);Incidence of major adverse events (1 month, 6 months, 12 months, 24 months);Target lesion restenosis rate (6 months, 12 months, 24 months); ABI changes (pre-discharge, 6 months, 12 months, 24 months);Rutherford grading changes (pre-discharge, 6 months, 12 months, 24 months);Remedial stent rate;Ulcer healing rate (6 months, 12 months, 24 months); Ulcer healing time;Incidence of device defects; | — |
Countries
China
Contacts
Public ContactChang Guangqi
The First Hospital of Zhongshan University
Outcome results
None listed