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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-27

Study Completion Date

2026-08-31

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.

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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.

Conditions

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Peripheral Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Drug eluting stent

Device: Drug-eluting peripheral arterial（G-stream） stent system Manufacturer：Alain Medical (Beijing) Co., Ltd.

Group Type EXPERIMENTAL

Drug eluting stent

Intervention Type DEVICE

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.

Drug coating balloon

Device: AcoArt-Orchid® Drug Eluting Balloon Catheter Manufacturer: Acotec Scientific Co., Ltd

Group Type ACTIVE_COMPARATOR

drug coating balloon

Intervention Type DEVICE

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.

Interventions

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Drug eluting stent

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.

Intervention Type DEVICE

drug coating balloon

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.

Intervention Type DEVICE

Other Intervention Names

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drug eluting percutaneous transluminal angioplasty (PTA) balloon

Eligibility Criteria

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Inclusion Criteria

1. Age from 18 to 80 years, male or female;
2. Patients with Lower extremity peripheral artery disease (PAD);
3. With Rutherford classification between 2 and 5;
4. 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;

1. Degree of stenosis ≥ 70% and \<100%, Total lesion length ≥ 20 mm and ≤ 250 mm; or
2. Occlusive lesions, total lesion length ≤ 150 mm; or
3. 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

1. Wtih vasculitis or Berger disease;
2. With severe coagulation disorders or uncontrolled severe infections, not suitable for intervention procedure;
3. Known hypersensitivity or contraindication to aspirin, clopidogrel, heparin, paclitaxel, rapamycin, contrast dye or others;
4. History of distal amputation (above the metatarsal) in the target limb or contralateral limb;
5. Severe renal insufficiency (creatinine \> 221 umol/L);
6. History of local thrombolysis or systemic thrombolysis within 48 hours prior to procedure;
7. History of acute myocardial infarction within 30 days prior to procedure;
8. 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;
9. History of alimentary tract hemorrhage within 3 months prior to procedure;
10. History of stroke/cerebrovascular accident (CVA) within 6 months prior to procedure;
11. Life expectancy \<12 months;
12. History of stent, drug-coated balloon or bypass surgery in the target lesion;
13. Use of atherectomy, laser, cryoplasty or other debulking devices in the target lesion during the index procedure;
14. Pregnant, breast feeding, or plan to become pregnant;
15. Current participation in another investigational drug or device clinical study;
16. According to the judgement of the investigator, other situations that are not suitable for enrollment;

17. Heavily calcified lesions;
18. Presence of aneurysm in the target vessel;
19. Acute or subacute thrombosis of the target vessel;
20. History of graft intervention in the target limb.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No