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

Salubris Pharmaceuticals

Status: Enrolling

Conditions: Peripheral Artery Disease

Treatments: Device: Drug eluting stent; Device: drug coating balloon

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05780359

TP-GS009

Details and patient eligibility

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.

Full description

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.

Enrollment: 280 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• General 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;

• Angiographic Inclusion Criteria： 5.Single lesions or tandem lesions located in the SFA and/or PPA:

  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

-General 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;

    • Angiographic Exclusion Criteria:

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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280 participants in 2 patient groups

Drug eluting stent

Experimental group

Description:

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

Treatment:

Device: Drug eluting stent

Drug coating balloon

Active Comparator group

Description:

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

Treatment:

Device: drug coating balloon