This is a randomized prospective study aiming to compare drug-coated balloons and stent deployment in Popliteal atherosclerotic occlusive lesions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
for popliteal stenosis/occlusive lesions, randomised received DCB or Stent deployment.
for popliteal stenosis/occlusive lesions, randomised received DCB or Stent deployment.
Gu Yong Quan
Beijing, Beijing Municipality, China
RECRUITINGPrimary patency of claudicant patients
Claudicant patients (Rutherford C1-3), primary patency defined as PSVR(peak systolic velocity ratio) ≤2.4, absence of restenosis \>50% based on an imaging study (Duplex ultrasound, CT angiography or catheter angiography) at 12 months
Time frame: 12 months after the index procedure
Salvage limb rate (for CLI patients)
Limb Salvage is defined as the freedom from secondary major amputation
Time frame: 12 months after the index procedure
Rutherford classification
Time frame: 12 months
ABI
Ankle Brachial index
Time frame: 12 months
TcpO2
transcutaneous oxygen pressure
Time frame: 12 months
Wagnar classification
incision healing information of Rutherford C5-6 patients
Time frame: 12 months
Target vessel revascularization rate
frequency of repeat intervention or surgical treatment due to loss of patency at the target vessel
Time frame: 12 months
Index Limb Ischemia at 12-month Follow up
Index Limb Ischemia is defined by Rutherford/Becker Classification categories 3 through 6.
Time frame: 12 months
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Major Adverse Events at 12-month Post Procedure
Major adverse events included death, index limb ischemia, index limb amputation, clinically driven target lesion revascularization, and significant embolic events, which were defined as causing end-organ damage.
Time frame: 12 months