About this trial
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.
Eligibility criteria
Qualifiers
General Inclusion Criteria:
Age from 18 to 80 years, male or female;
Patients with Lower extremity peripheral artery disease (PAD);
With Rutherford classification between 2 and 5;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Drug eluting stent
- drug coating balloon
Treatment groups
Sponsors and collaborators
Shenzhen Salubris Pharmaceuticals Co., Ltd.
Lead sponsor
Changhai Hospital
Collaborator