Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2025-12-26 @ 6:56 PM
Study NCT ID:
NCT05780359
Status:
RECRUITING
Last Update Posted:
2023-03-22
First Post:
2023-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Safety and Efficacy of the G-stream® Drug-Eluting Stent in the Above-the-Knee Femoropopliteal Artery
Sponsor:
Shenzhen Salubris Pharmaceuticals Co., Ltd.
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
G-streamPAD
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: