Symptomatic subclavian artery stenosis
Conditions
Interventions
Balloon Expandable Vascular Covered Stent group:Balloon Expandable Vascular Covered Stent Therapy
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. The subject provides inform consent using an Informed Consent Form (ICF) that is reviewed and approved by the Ethics Committee (EC) / Institutional Review Board (IRB) for the site. 2. Subject agrees to comply with the protocol-mandated follow-up procedures and visits. 3. Men or women aged = 18 and = 80 years old. 4. Subjects had symptoms of Subclavian artery stenosis, such as TIA/stroke history or steal blood syndrome or decreased quality of life. 5. The subjects can and are willing to comply with the medication regulations of the protocol. Angiography inclusion criteria: 6. There is evidence that the subject's autologous Subclavian artery has single, bilateral or multiple primary and/or restenosis (non stent) lesions, and the degree of stenosis is = 50% (including complete occlusion) according to the visual assessment of the investigator. 7. The target lesion can be successfully passed through using a guide wire, and appropriate sized PTA balloons can be used for pre dilation. Can make the balloon dilated covered stents assisted by chronic total occlusion (CTO) catheters and re-entry instruments for target lesion penetration pass. 8.According to the researcher's visual evaluation, the reference vessel diameter ranges from 4.5mm to 12.0mm. 9.According to the researcher's visual evaluation, the total length of the target lesion (unilateral) is = 100mm. 10. Angiography showed that the vertebral artery and/or axillary artery on the affected side of the subject were unobstructed, that is, the stenosis was assessed visually by the investigator narrow<50%.
Exclusion criteria
Exclusion criteria: 1. Breastfeeding or pregnant women, or women or men with recent fertility plans. 2. Expected life<2 years. 3. Patients currently undergoing other clinical endovascular treatment studies. 4. Infectious vascular disease; active systemic infection or uncontrolled coagulation dysfunction within 14 days before surgery. 5. Vascular lesions require emergency surgical treatment for patients. 6. There are no suitable arterial lesions in the inflow and outflow channels. 7. Subjects with a history of myocardial infarction or unstable angina within 3 months; Severe cardiac insufficiency; Mental illness that cannot cooperate independently; Severe allergy to contrast agents. 8. Unable to follow up regularly according to the plan requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Device and/or procedure-related death through 30 days post-index procedure;ischemic stroke through 30 days post-index procedure;upper limb ischemia through 30 days post-index procedure;Target Lesion Re-intervention (TLR) at 6- and 12-months post-index procedure;Primary Patency at 6- and 12-months post-index procedure;symptom relief; | — |
Secondary
| Measure | Time frame |
|---|---|
| Technical Success (successful deployment of the BARD LIFESTREAM Balloon Expandable Vascular Covered Stent at the intended location);Secondary Patency at 6- and 12-months post-index procedure; | — |
Countries
China
Contacts
Public ContactQiang Guo
West China Hospital, Sichuan University
Outcome results
None listed