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

Not Applicable

Recruiting

• Conditions: Peripheral Artery Disease
• Interventions: Device: Drug eluting stent; Device: drug coating balloon

• Registration Number: NCT05780359
• Lead Sponsor: Shenzhen Salubris Pharmaceuticals Co., Ltd.

Brief Summary

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

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 Timeline

• Study Start: 2022-05-27
• Status Verified: 2023-03
• Study First Submitted: 2023-03-08
• Study First Submitted QC: 2023-03-20
• Last Update Submitted: 2023-03-20
• Study First Posted: 2023-03-22
• Last Update Posted: 2023-03-22
• Primary Completion: 2025-06-30
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 280

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug eluting stent	Drug eluting stent	Device: Drug-eluting peripheral arterial（G-stream） stent system Manufacturer：Alain Medical (Beijing) Co., Ltd.
Drug coating balloon	drug coating balloon	Device: AcoArt-Orchid® Drug Eluting Balloon Catheter Manufacturer: Acotec Scientific Co., Ltd

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Reaching Primary patency	12 months	Primary patency defined as freedom from clinically-driven target lesion revascularization and CT angiography diagnosis of freedom from restenosis (ie, stenosis ≤ 50%);

Secondary Outcome Measures

Name	Time	Method
Device success rate	During the procedure	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.
Distribution of Rutherford classification	30 days, 3 months, 6 months and 12 months	Changing in categories of Rutherford classification.
Distribution of Ankle Brachial Index(ABI)	6 months and 12 months	Changing in ABI between 6 to 12 months.
Percentage of Participants with major and minor amputations of the treated leg	30 days, 3 months, 6 months and 12 months	Major amputation defined as amputation above the ankle and minor as below the ankle.
Percentage of Participants With Major Adverse Events (MAEs)	30 days, 3 months, 6 months and 12 months	MAEs defined as all-cause death, target limb major amputation and/or target lesion revascularization (TLR).
Procedural success rate	During the procedure	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.
Clinical success rate	12 months	Clinical success was defined as procedural success without server complications (death, target limb major amputation and/or target lesion revascularization (TLR).
Percentage of Participants With TLR and clinical drived-TLR (CD-TLR)	30 days, 3 months, 6 months and 12 months	TLR is defined as any surgical or percutaneous intervention to the target lesion(s) after the index procedure.
Percentage of Participants With all-cause Death	30 days, 3 months, 6 months and 12 months
Percentage of Participants With Target Vessel Revascularization (TVR) and Clinical Drived-TVR (CD-TVR)	30 days, 3 months, 6 months and 12 months	TVR is defined as any surgical or percutaneous intervention to the target vessel(s) after the index procedure.
Percentage of Participants With Lower Extremity Arterial Thrombosis	30 days, 3 months, 6 months and 12 months

Trial Locations

Locations (1)

Changhai Hospital of Shanghai; 🇨🇳 Shanghai, Shanghai, China