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A multicenter, randomized, controlled, superiority clinical trial to evaluate the efficacy and safety of drug-eluting peripheral arterial stent system(G-stream) in the treatment of femoropopliteal artery stenosis or occlusion.
Full description
To evaluate the efficacy and safety of the drug-eluting peripheral arterial stent system(G-stream) in the treatment of superficial femoral artery and/or proximal popliteal artery. Taking the drug eluting balloon catheter (AcoArt-Orchid) as control.
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Inclusion criteria
General Inclusion Criteria:
Angiographic Inclusion Criteria: 5.Single lesions or tandem lesions located in the SFA and/or PPA:
Exclusion criteria
-General Exclusion Criteria:
Wtih vasculitis or Berger disease;
With severe coagulation disorders or uncontrolled severe infections, not suitable for intervention procedure;
Known hypersensitivity or contraindication to aspirin, clopidogrel, heparin, paclitaxel, rapamycin, contrast dye or others;
History of distal amputation (above the metatarsal) in the target limb or contralateral limb;
Severe renal insufficiency (creatinine > 221 umol/L);
History of local thrombolysis or systemic thrombolysis within 48 hours prior to procedure;
History of acute myocardial infarction within 30 days prior to procedure;
History of major surgery(i.e., open cardiac operation, open abdominal surgery or open operation for peripheral artery disease) within 30 days prior to procedure;
History of alimentary tract hemorrhage within 3 months prior to procedure;
History of stroke/cerebrovascular accident (CVA) within 6 months prior to procedure;
Life expectancy <12 months;
History of stent, drug-coated balloon or bypass surgery in the target lesion;
Use of atherectomy, laser, cryoplasty or other debulking devices in the target lesion during the index procedure;
Pregnant, breast feeding, or plan to become pregnant;
Current participation in another investigational drug or device clinical study;
According to the judgement of the investigator, other situations that are not suitable for enrollment;
Heavily calcified lesions;
Presence of aneurysm in the target vessel;
Acute or subacute thrombosis of the target vessel;
History of graft intervention in the target limb.
Primary purpose
Allocation
Interventional model
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280 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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