Peripheral Arterial Disease Clinical Trial
Official title:
The Safety and Efficacy of Drug Eluting Peripheral Vascular Stent System for the Treatment of Superficial Femoral Artery Stenosis and /or Occlusion: a Multi-center Stratified Randomized Single- Blind Controlled Trial
Evaluation of drug eluting peripheral vascular stent system for the treatment of superficial femoral artery stenosis and / or occlusion, there is better in effectiveness and clinical performance compared with similar products already on the market.
Status | Recruiting |
Enrollment | 138 |
Est. completion date | February 2021 |
Est. primary completion date | July 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria in Preoperative: - Aged from 18 to 85 years old, male or female - Subject's target lesions were stenosis and/or occlusion - Subject is aware of the study content, showing sufficient compliance with the research protocol and sign the Informed Consent Exclusion Criteria in Preoperative: - In-Stent Restenosis(IRS) or restenosis after drug-eluting balloon administration - Serum creatinine concentration of the subject is higher than 1.5 times of the upper limit of normal serum creatinine concentration - Subject with coagulation abnormalities should not be performed |
Country | Name | City | State |
---|---|---|---|
China | West China Hospital, Sichuan University | Chengdu |
Lead Sponsor | Collaborator |
---|---|
Zhejiang Zylox Medical Device Co., Ltd. | Guangzhou Osmunda Medical Device Technology, Inc., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | primary patency rate at 12 months after operation | the rate of the target lesion diameter stenosis <50% patients confirmed by Color Doppler Ultrasonography (CDU) imaging at 12 months postoperatively | 12 months | |
Secondary | primary patency rate at 6 months after operation | the rate of the target lesion diameter stenosis <50% patients confirmed by Color Doppler Ultrasonography (CDU) imaging at 6 months postoperatively | 6 months | |
Secondary | target lesion revascularization rate | subject found that the presence of restenosis in the target lesion in follow-up , and need to re-intervention or bypass graft according to the clinical symptoms | Preoperative,up to 1 month,6 months,12 months | |
Secondary | Stent fracture rate | using the Dual Fluoroscopic Imaging | 6 months?12 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06032065 -
Sequential Multiple Assessment Randomized Trial of Exercise for PAD: SMART Exercise for PAD (SMART PAD)
|
Phase 3 | |
Active, not recruiting |
NCT03987061 -
MOTIV Bioresorbable Scaffold in BTK Artery Disease
|
N/A | |
Recruiting |
NCT03506633 -
Impacts of Mitochondrial-targeted Antioxidant on Peripheral Artery Disease Patients
|
N/A | |
Active, not recruiting |
NCT03506646 -
Dietary Nitrate Supplementation and Thermoregulation
|
N/A | |
Active, not recruiting |
NCT04677725 -
NEtwork to Control ATherothrombosis (NEAT Registry)
|
||
Recruiting |
NCT05961943 -
RESPONSE-2-PAD to Reduce Sedentary Time in Peripheral Arterial Disease Patients
|
N/A | |
Recruiting |
NCT06047002 -
Personalised Antiplatelet Therapy for Patients With Symptomatic Peripheral Arterial Disease
|
||
Completed |
NCT03185052 -
Feasibility of Outpatient Care After Manual Compression in Patients Treated for Peripheral Arterial Disease by Endovascular Technique With 5F Sheath Femoral Approach
|
N/A | |
Recruiting |
NCT05992896 -
A Study of Loco-Regional Liposomal Bupivacaine Injection
|
Phase 4 | |
Completed |
NCT04635501 -
AbsorbaSeal (ABS 5.6.7) Vascular Closure Device Trial
|
N/A | |
Recruiting |
NCT04584632 -
The Efemoral Vascular Scaffold System (EVSS) for the Treatment of Patients With Symptomatic Peripheral Vascular Disease From Stenosis or Occlusion of the Femoropopliteal Artery
|
N/A | |
Withdrawn |
NCT03994185 -
The Merit WRAPSODY™ Endovascular Stent Graft for Treatment of Iliac Artery Occlusive Disease
|
N/A | |
Withdrawn |
NCT03538392 -
Serranator® Alto Post Market Clinical Follow Up (PMCF) Study
|
||
Recruiting |
NCT02915796 -
Autologous CD133(+) Cells as an Adjuvant to Below the Knee Percutaneous Transluminal Angioplasty
|
Phase 1 | |
Active, not recruiting |
NCT02900924 -
Observational Study to Evaluate the BioMimics 3D Stent System: MIMICS-3D
|
||
Completed |
NCT02901847 -
To Evaluate the Introduction of a Public Health Approach to Peripheral Arterial Disease (PAD) Using National Centre for Sport and Exercise Medicine Facilities.
|
N/A | |
Withdrawn |
NCT02126540 -
Trial of Pantheris System, an Atherectomy Device That Provides Imaging While Removing Plaque in Lower Extremity Arteries
|
N/A | |
Not yet recruiting |
NCT02387450 -
Reduced Cardiovascular Morbi-mortality by Sildenafil in Patients With Arterial Claudication
|
Phase 2/Phase 3 | |
Not yet recruiting |
NCT02455726 -
Magnesium Oral Supplementation to Reduce Pain Inpatients With Severe Peripheral Arterial Occlusive Disease
|
N/A | |
Completed |
NCT02384980 -
Saving Life and Limb: FES for the Elderly With PAD
|
Phase 1 |