T he Purpose of the Study is to evaluation of the Long-Term Safety and Effectiveness of a Drug-Coated Peripheral Balloon Dilatation Catheter in the Treatment of Femoropopliteal Artery Stenoses or Occlusive Lesions.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
150
The subjects underwent drug coating balloon angioplasty to treat femoropopliteal artery stenosis or occlusive lesions
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chognqing, China
Primary Patency Rate at 12 months post-procedure
12-month primary patency of the target lesion is defined as: absence of clinically driven target lesion revascularization and no Doppler ultrasound-diagnosed target lesion restenosis within 12 months postoperatively. Doppler ultrasound-diagnosed restenosis refers to a peak systolic velocity ratio (PSVR) ≥2.4 at the target lesion (indicating ≥50% luminal stenosis). Clinically Driven: Rutherford classification increase, ABI decrease, or imaging evidence of ≥70% stenosis. Target Lesion Revascularization: Includes any endovascular or open procedure at the target lesion site (e.g., PTA, stent placement, bypass surgery, thrombectomy, thrombolysis) or major amputation of the target limb.
Time frame: 12 months
Device Success Rate
Time frame: Immediately after procedure
Primary Patency Rate at 24 months post-procedure
Time frame: 24 months
Target Lesion Revascularization (TLR) Rate at 12 amd 24 months post-procedure
Time frame: 12 months; 24 months
Change in Rutherford classification from baseline at 6, 12, and 24 months postoperatively
Time frame: 6, 12, 24 months
Change in ABI (ankle-brachial index) from baseline at 12 and 24 months postoperatively
Time frame: 12, 24 months
MAEs Rates at 12 Months and 24 Months Post-Procedure
MAEs: Include all-cause mortality within 30 days post-procedure, amputation of the treated limb, and clinically driven target vessel revascularization (TVR).
Time frame: 12, 24 months
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