Actively Recruiting
Evaluating the Safety and Efficacy of the G-stream® Drug-Eluting Stent in the Above-the-Knee Femoropopliteal Artery
Led by Shenzhen Salubris Pharmaceuticals Co., Ltd. · Updated on 2023-03-22
280
Participants Needed
1
Research Sites
222 weeks
Total Duration
On this page
Sponsors
S
Shenzhen Salubris Pharmaceuticals Co., Ltd.
Lead Sponsor
C
Changhai Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluating the Safety and Efficacy of the G-stream® Drug-Eluting Stent in the Above-the-Knee Femoropopliteal Artery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age from 18 to 80 years, male or female
- Patients with lower extremity peripheral artery disease (PAD)
- Rutherford classification between 2 and 5
- Patients understand the study purpose, voluntarily participate, sign consent, and agree to follow all study requirements and visits
- Single or tandem lesions in superficial femoral artery and/or proximal popliteal artery with stenosis ≥ 70% and < 100%, lesion length 20-250 mm; or occlusive lesions with total length ≤ 150 mm; or series of lesions with total length ≤ 250 mm and occlusive lesions ≤ 150 mm
- Vessel diameter between 3.5 and 7.5 mm by angiographic assessment
- Successful re-entry device crossing of the target lesion
- Residual stenosis after predilation ≤ 50% without severe dissection (type D or greater)
- Patent homolateral iliac inflow (stenosis ≤ 50%) or treated lesion with residual stenosis < 30% without severe flow-limiting dissection or serious adverse events
- Patent infrapopliteal and popliteal artery with at least one patent vessel to the ankle or foot before procedure or planned intervention
You will not qualify if you...
- Vasculitis or Berger disease
- Severe coagulation disorders or uncontrolled severe infections unsuitable for intervention
- Known hypersensitivity or contraindication to aspirin, clopidogrel, heparin, paclitaxel, rapamycin, contrast dye, or others
- History of distal amputation above the metatarsal in target or contralateral limb
- Severe renal insufficiency (creatinine > 221 umol/L)
- Local or systemic thrombolysis within 48 hours prior to procedure
- Acute myocardial infarction within 30 days prior to procedure
- Major surgery within 30 days prior to procedure (open cardiac, abdominal, or peripheral artery surgery)
- Alimentary tract hemorrhage within 3 months prior to procedure
- Stroke or cerebrovascular accident within 6 months prior to procedure
- Life expectancy less than 12 months
- History of stent, drug-coated balloon, or bypass surgery in target lesion
- Use of atherectomy, laser, cryoplasty, or other debulking devices in target lesion during procedure
- Pregnant, breastfeeding, or planning pregnancy
- Current participation in another investigational drug or device study
- Other investigator-judged unsuitable situations
- Heavily calcified lesions
- Presence of aneurysm in target vessel
- Acute or subacute thrombosis of target vessel
- History of graft intervention in target limb
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Changhai Hospital of Shanghai
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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