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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
280
Sirolimus 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.
A 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.
Changhai Hospital of Shanghai
Shanghai, Shanghai Municipality, China
RECRUITINGPercentage 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%);
Time frame: 12 months
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.
Time frame: During the procedure
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.
Time frame: During the procedure
Clinical success rate
Clinical success was defined as procedural success without server complications (death, target limb major amputation and/or target lesion revascularization (TLR).
Time frame: 12 months
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.
Time frame: 30 days, 3 months, 6 months and 12 months
Percentage of Participants With Target Vessel Revascularization (TVR) and Clinical Drived-TVR (CD-TVR)
TVR is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure.
Time frame: 30 days, 3 months, 6 months and 12 months
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Percentage of Participants With Major Adverse Events (MAEs)
MAEs defined as all-cause death, target limb major amputation and/or target lesion revascularization (TLR).
Time frame: 30 days, 3 months, 6 months and 12 months
Percentage of Participants With all-cause Death
Time frame: 30 days, 3 months, 6 months and 12 months
Distribution of Rutherford classification
Changing in categories of Rutherford classification.
Time frame: 30 days, 3 months, 6 months and 12 months
Distribution of Ankle Brachial Index(ABI)
Changing in ABI between 6 to 12 months.
Time frame: 6 months and 12 months
Percentage of Participants With Lower Extremity Arterial Thrombosis
Time frame: 30 days, 3 months, 6 months and 12 months
Percentage of Participants with major and minor amputations of the treated leg
Major amputation defined as amputation above the ankle and minor as below the ankle.
Time frame: 30 days, 3 months, 6 months and 12 months