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

Shenzhen Salubris Pharmaceuticals Co., Ltd.1 site in 1 country280 target enrollmentMay 27, 2022

ConditionsPeripheral Artery Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Peripheral Artery Disease
Sponsor: Shenzhen Salubris Pharmaceuticals Co., Ltd.
Enrollment: 280
Locations: 1
Primary Endpoint: Percentage of Participants Reaching Primary patency
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 27, 2022

End Date

August 31, 2026

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shenzhen Salubris Pharmaceuticals Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•General Inclusion Criteria：
•Age from 18 to 80 years, male or female;
•Patients with Lower extremity peripheral artery disease (PAD);
•With Rutherford classification between 2 and 5;
•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:
•Degree of stenosis ≥ 70% and \<100%, Total lesion length ≥ 20 mm and ≤ 250 mm; or
•Occlusive lesions, total lesion length ≤ 150 mm; or
•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；
•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：
•Wtih vasculitis or Berger disease;
•With severe coagulation disorders or uncontrolled severe infections, not suitable for intervention procedure;
•Known hypersensitivity or contraindication to aspirin, clopidogrel, heparin, paclitaxel, rapamycin, contrast dye or others;
•History of distal amputation (above the metatarsal) in the target limb or contralateral limb;
•Severe renal insufficiency (creatinine \> 221 umol/L);
•History of local thrombolysis or systemic thrombolysis within 48 hours prior to procedure;
•History of acute myocardial infarction within 30 days prior to procedure;
•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;
•History of alimentary tract hemorrhage within 3 months prior to procedure;

Outcomes

Primary Outcomes

Percentage of Participants Reaching Primary patency

Time Frame: 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 Outcomes

Device success rate(During the procedure)
Distribution of Rutherford classification(30 days, 3 months, 6 months and 12 months)
Distribution of Ankle Brachial Index(ABI)(6 months and 12 months)
Percentage of Participants with major and minor amputations of the treated leg(30 days, 3 months, 6 months and 12 months)
Percentage of Participants With Major Adverse Events (MAEs)(30 days, 3 months, 6 months and 12 months)
Procedural success rate(During the procedure)
Clinical success rate(12 months)
Percentage of Participants With TLR and clinical drived-TLR (CD-TLR)(30 days, 3 months, 6 months and 12 months)
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)
Percentage of Participants With Lower Extremity Arterial Thrombosis(30 days, 3 months, 6 months and 12 months)