Stenosis or occlusion of the femoropopliteal artery
Conditions
Interventions
Experimental group:Peripheral drug-coated balloon angioplasty catheters was used
Control group:Drug-eluting peripheral balloon dilatation catheter was used
Sponsors
Tianjin Medical University General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.18 > = age = 70% or complete occlusion (the length of occlusion is not more than 100mm), and the conventional method can be used to pass; 7. The reference diameter of the target vessel was between 2.0mm and 7.0mm. 8. The target lesion is a single lesion on the affected side, or adjacent lesions or combined lesions or lesions that meet the following requirements: (1) adjacent lesions: 1) the distance between the lesions is not more than 30mm 2) the total length of the lesions (including the distance) is not more than 280mm 3) can be treated as a single lesion; (2) Combined lesion: the combined lesion in this study refers to the total occlusion lesion combined with the common lesion, the total occlusion length is not more than 100mm, and the total length of the combined lesion is not more than 280mm. (3) Multiple lesions: 1) spacing more than 30mm 2) Total lesion length (including spacing) no more than 280mm 3) can be treated as multiple lesions. 9. Angiography showed at least one vessel on the affected side leading to the foot (at least one autologous vessel in the leg was patent, i.e., <50% stenosis); 10. If the subject has an ipsilateral/contralateral iliac lesion requiring treatment during the procedure, the iliac lesion must meet all of the following criteria: (1) the length of stenosis or occlusion of the iliac lesion is < = 100mm; (2) treatment must be performed before the target lesion (superficial femoral artery/proximal popliteal artery); (3) The target lesion must be successfully cured before treatment. Successful cure was defined as: 1) residual stenosis less than 30%; 2) There is no dissection affecting blood flow; 3) No thrombosis, embolism or other serious adverse events occurred.
Exclusion criteria
Exclusion criteria: 1. Women of childbearing age with non-negative pregnancy test before interventional surgery and lactating women; (2) patients with stroke (except lacunar infarction) or acute myocardial infarction within 30 days before surgery; 3. Received local or systemic thrombolytic therapy within 4 weeks before surgery; 4. Previous limb bypass surgery; 5. Previous allergy or contraindications to contrast media, rapamycin, paclitaxel, antiplatelet, anticoagulant or thrombolytic drugs; 6. Renal insufficiency (eGFR =C) or residual stenosis >30%.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary patency rates within 12 months after the initial procedure;Avoidance of major adverse event rates; | — |
Secondary
| Measure | Time frame |
|---|---|
| Device Success rate;Technical success rate;Surgical success rate;Rutherford grade;All-cause death;Ankle-brachial index (ABI) or toe-brachial index (TBI);6-minute walk test (6MWT);Secondary patency rate;Limb-related death;Major amputation and minor amputation;(TLR, CD-TLR, TVR, CD-TVR) incidence;Thrombosis at the target lesion site;Reintervention due to distal vascular embolism of the target lesion;Rehospitalization cardiovascular events;Major adverse events; | — |
Countries
China
Contacts
Public ContactXiangchen Dai
Tianjin Medical University General Hospital
Outcome results
None listed