A prospective randomized trial to validate the efficacy and safety of rapamycin coated peripheral balloon catheter in the treatment of femoral popliteal artery disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
276
Treatment of stenosis or occlusion of superficial femoral artery and/or popliteal artery with rapamycin coated balloon catheter.
Paclitaxel coated balloon catheter for the treatment of stenosis or occlusion of superficial femoral artery and/or popliteal artery.
The First Medical Center of the General Hospital of the Chinese People's Liberation Army
Beijing, Beijing Municipality, China
primary patency rate, PPR.
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.
Time frame: 12months
Device success rate
It is defined as: the balloon catheter can reach the target lesion, expand successfully, without rupture, and withdraw successfully.
Time frame: The day of operation.
Operation success rate
The success of surgery was defined as: residual stenosis ≤ 50% (without salvage stent implantation) or ≤ 30% (with salvage stent implantation).
Time frame: 1DAY
Target Lesion Revascularization incidence.
Target Lesion Revascularization is defined as any re intervention treatment required in the target lesion.
Time frame: 12 months after operation.
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