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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Multicenter, Randomized, Controlled, Superiority Clinical Trial to Evaluate the Safety and Efficacy of Drug-eluting Peripheral Arterial Stent System（G-stream） in the Treatment of the Above-the-knee Femoropopliteal Artery Stenosis or Occlusion

Conditions
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Peripheral Artery Disease

Intervention / Treatment
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* Device: Drug eluting stent
* Device: drug coating balloon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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; Patients understand the purpose of the study, voluntary participation of the study, signs the consent form, willing and able to comply with all requirements, and agrees to attend all required follow-up visits; Angiographic Inclusion Criteria： 5.Single lesions or tandem lesions located in the SFA and/or PPA: Degree of stenosis ≥ 70% and <100%, Total lesion length ≥ 20 mm and ≤ 250 mm; or Occlusive lesions, total lesion length ≤ 150 mm; or Series of lesions, total lesion length ≤ 250 mm and length of occlusive lesions ≤ 150 mm; 6.Vessel diameter ≥ 3.5 and ≤ 7.5 mm by visual angiographic assessment; 7.Re-entry device reach and cross a target lesion successfully; 8.Residual stenosis after predilation ≤ 50% without dissection characterized as type D or greater； 9. Patent homolateral iliac inflow (stenosis ≤ 50% ) or homolateral iliac inflow lesion received successfully treated i.e., residual stenosis < 30% after treatment, without severe flow-limiting dissection characterized as type D or greater, without thrombosis, embolism or other serious adverse events; 10.Patent infrapopliteal and popliteal artery, i.e., single vessel runoff or better with at least one of three vessels patent (stenosis ≤ 50%) to the ankle or foot before procedure or with planned intervention. 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; Angiographic Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug eluting stent<br>Device: Drug-eluting peripheral arterial（G-stream） stent system Manufacturer：Alain Medical (Beijing) Co., Ltd. | Device: Drug eluting stent<br>* 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.<br>|
| Active Comparator: Drug coating balloon<br>Device: AcoArt-Orchid® Drug Eluting Balloon Catheter Manufacturer: Acotec Scientific Co., Ltd | Device: drug coating balloon<br>* 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.<br>* Other names: drug eluting percutaneous transluminal angioplasty (PTA) balloon;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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%); | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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). | 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. | 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. | 30 days, 3 months, 6 months and 12 months | 
| Percentage of Participants With Major Adverse Events (MAEs) | MAEs defined as all-cause death, target limb major amputation and/or target lesion revascularization (TLR). | 30 days, 3 months, 6 months and 12 months | 
| Percentage of Participants With all-cause Death |  | 30 days, 3 months, 6 months and 12 months | 
| Distribution of Rutherford classification | Changing in categories of Rutherford classification. | 30 days, 3 months, 6 months and 12 months | 
| Distribution of Ankle Brachial Index(ABI) | Changing in ABI between 6 to 12 months. | 6 months and 12 months | 
| Percentage of Participants With Lower Extremity Arterial Thrombosis |  | 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. | 30 days, 3 months, 6 months and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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drug eluting stent, drug coating ballon, Peripheral Artery Disease