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

NARecruitingINTERVENTIONAL
Enrollment

280

Participants

Timeline

Start Date

May 27, 2022

Primary Completion Date

June 30, 2025

Study Completion Date

August 31, 2026

Conditions
Peripheral Artery Disease
Interventions
DEVICE

Drug eluting stent

Sirolimus drug-eluting self-expanding stent available from 20mm to 250mm in length, 3.5mm to 7.5mm in diameter of superficial femoral and proximal popliteal arteries (SFA/PPA) cases for inhibiting in-stent restenosis and improve long-term outcome.

DEVICE

drug coating balloon

A proprietary lipophilic coating technology that uses magnesium sterate as excipient, facilitates paclitaxel transfer to the vessel wall, enhances drug delivery, and brings minimal downstream effect. Available from 20mm to 300 mm in length, 3mm to 12 mm in diameter, fits every SFA cases, reduces radiation exposure time.

Trial Locations (1)

200433

RECRUITING

Changhai Hospital of Shanghai, Shanghai

All Listed Sponsors
collaborator

Changhai Hospital

OTHER

lead

Shenzhen Salubris Pharmaceuticals Co., Ltd.

INDUSTRY