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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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; 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.

Locations
Other Locations
China
Changhai Hospital of Shanghai
RECRUITING
Shanghai
Time Frame
Start Date: 2022-05-27
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 280
Treatments
Experimental: Drug eluting stent
Device: Drug-eluting peripheral arterial(G-stream) stent system Manufacturer:Alain Medical (Beijing) Co., Ltd.
Active_comparator: Drug coating balloon
Device: AcoArt-Orchid® Drug Eluting Balloon Catheter Manufacturer: Acotec Scientific Co., Ltd
Sponsors
Leads: Shenzhen Salubris Pharmaceuticals Co., Ltd.
Collaborators: Changhai Hospital

This content was sourced from clinicaltrials.gov