Evaluating the Safety and Efficacy of the G-stream® Drug-Eluting Stent in the Above-the-Kn
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.
| Condition(s) | Peripheral Artery Disease |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | 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 vi |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Lead sponsor | Shenzhen Salubris Pharmaceuticals Co., Ltd. |
| Locations | Shanghai, Shanghai Municipality, China |
| Start date | 2022-05-27 |
| NCT ID | NCT05780359 |
| Official listing | https://clinicaltrials.gov/study/NCT05780359 |