Clinical trial NCT05780359: Evaluating the Safety and Efficacy of the G-stream® Drug-Eluting Stent in the Above-the-Knee Femoropopliteal Artery
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peripheral Artery Disease
Keywords: drug eluting stent
drug coating ballon
Peripheral Artery Disease
Lead sponsor: Shenzhen Salubris Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Changhai Hospital
First posted: 2023-03-22
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Reaching Primary patency
timeFrame: 12 months
Secondary outcomes:
measure: Device success rate
timeFrame: During the procedure
measure: Procedural success rate
timeFrame: During the procedure
measure: Clinical success rate
timeFrame: 12 months
measure: Percentage of Participants With TLR and clinical drived-TLR (CD-TLR)
timeFrame: 30 days, 3 months, 6 months and 12 months
measure: Percentage of Participants With Target Vessel Revascularization (TVR) and Clinical Drived-TVR (CD-TVR)
timeFrame: 30 days, 3 months, 6 months and 12 months
measure: Percentage of Participants With Major Adverse Events (MAEs)
timeFrame: 30 days, 3 months, 6 months and 12 months
measure: Percentage of Participants With all-cause Death
timeFrame: 30 days, 3 months, 6 months and 12 months
measure: Distribution of Rutherford classification
timeFrame: 30 days, 3 months, 6 months and 12 months
measure: Distribution of Ankle Brachial Index(ABI)
timeFrame: 6 months and 12 months
measure: Percentage of Participants With Lower Extremity Arterial Thrombosis
timeFrame: 30 days, 3 months, 6 months and 12 months
measure: Percentage of Participants with major and minor amputations of the treated leg
timeFrame: 30 days, 3 months, 6 months and 12 months
Other outcomes:
measure: Adverse Events (AE) and Serious Adverse Events (SAE) related to Device
timeFrame: 24 months
measure: other Adverse Events (AE) and Serious Adverse Events (SAE)
timeFrame: 24 months
measure: Percentage of Participants Reaching Primary patency
timeFrame: 24 months
measure: Percentage of Participants With TLR and CD-TLR
timeFrame: 18 months and 24 months
measure: Percentage of Participants With TVR and CD-TVR
timeFrame: 18 months and 24 months
measure: Percentage of Participants With MAEs
timeFrame: 18 months and 24 months
measure: Percentage of Participants With all-cause Death
timeFrame: 18 months and 24 months
measure: Distribution of Rutherford classification
timeFrame: 18 months and 24 months
measure: Distribution of Ankle Brachial Index(ABI)
timeFrame: 24 months
measure: Percentage of Participants With Lower Extremity Arterial Thrombosis
timeFrame: 18 months and 24 months
measure: Percentage of Participants with major and minor amputations of the treated leg
timeFrame: 18 months and 24 months
Locations:
city: Shanghai
country: China
facility: Changhai Hospital of Shanghai
state: Shanghai
Study officials:
References:
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