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.
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;
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;
Parallel
Drug eluting stent
DeviceSirolimus drug-eluting self-expanding stent available from 20mm to 250mm in length, 3.5mm to 7.5mm in diameter of superficial femoral and proximal popliteal arteries (SFA/PPA) cases for inhibiting in-stent restenosis and improve long-term outcome.
drug coating balloon
DeviceA proprietary lipophilic coating technology that uses magnesium sterate as excipient, facilitates paclitaxel transfer to the vessel wall, enhances drug delivery, and brings minimal downstream effect. Available from 20mm to 300 mm in length, 3mm to 12 mm in diameter, fits every SFA cases, reduces radiation exposure time.
Percentage of Participants Reaching Primary patency
Primary patency defined as freedom from clinically-driven target lesion revascularization and CT angiography diagnosis of freedom from restenosis (ie, stenosis ≤ 50%);
Device success rate
Device success was defined as successful arrival of stent/balloon to the lesion. And subsequent release of the stent delivery system or dilation of balloon. Then withdraw delivery system successfully.
Procedural success rate
Procedural success was defined as delivery and deployment of the assigned stent/balloon to the target lesion to achieve residual angiographic stenosis no greater than 50% for balloon and 30% for stent.
Clinical success rate
Clinical success was defined as procedural success without server complications (death, target limb major amputation and/or target lesion revascularization (TLR).
Percentage of Participants With TLR and clinical drived-TLR (CD-TLR)
TLR is defined as any surgical or percutaneous intervention to the target lesion(s) after the index procedure.
Adverse Events (AE) and Serious Adverse Events (SAE) related to Device
Percentage of Participants with AE and SAE related to device.
other Adverse Events (AE) and Serious Adverse Events (SAE)
Percentage of Participants with AE and SAE not related to device.
Percentage of Participants Reaching Primary patency
Primary patency defined as freedom from clinically-driven target lesion revascularization and CT angiography diagnosis of freedom from restenosis (ie, stenosis ≤ 50%).
Percentage of Participants With TLR and CD-TLR
TLR is defined as any surgical or percutaneous intervention to the target lesion(s) after the index procedure.
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Shenzhen Salubris Pharmaceuticals Co., Ltd.
Lead sponsor
Changhai Hospital
Collaborator
