Evaluating the Safety and Efficacy of the G-stream® Drug-Eluting Stent in the Above-the-Knee Femoropopliteal Artery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShenzhen Salubris Pharmaceuticals Co., Ltd.

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

280 Participants
are divided into 2 treatment groups

Sponsors and collaborators