Ankura™ TAA Stent Graft System Post-Market Clinical Follow-up Study: Multi-center, Prospective, Observational, Post-Market Follow-up Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aneurysm Thoracic
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
- Enrollment
- 145
- Locations
- 8
- Primary Endpoint
- Incidence of major adverse events
- Status
- Recruiting
- Last Updated
- 10 months ago
Overview
Brief Summary
The purpose of this study is to collect clinical data on patient outcomes, evaluate the safety and performance of Ankura TAA Stent Graft System and Surpass Super Stiff Guidewire, and build clinical evidence for patients with Descending Thoracic Aneurysm (DTA) or Type B Aortic Dissection (TBAD).
Detailed Description
The physician shall strictly follow the clinical study protocol and shall not deviate from or substantially change the protocol. However, in case of emergency such as immediate risk to the subjects, which needs tobe eliminated immediately, it may be reported in written form afterwards. During the course of the study,documents such as amendments to the clinical study protocol and informed consent, requests for deviation,and resumption of the suspended clinical study shall be subject to the written approval of the Ethics Committee
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient has descending thoracic aortic aneurysm (DTA) or type B aortic dissection (TBAD), who needs endovascular repair (TEVAR).
- •Life expectancy \> 1 year.
- •Patient or legally authorized representative understands the nature of the clinical trial, agrees to its provisions, agrees to comply with the requirements of the study including a 3-year follow-up, and signed applicable Informed Consent Form.
- •Patient's characteristics consistent with Ankura™ Stent Graft System IFU and sizing guidelines, which indicate as following:
- •For descending thoracic aortic aneurysm (DTA) patient:
- •Adequate iliac/femoral access vessel that is compatible with the required delivery system.
- •Aortic inner diameter in the range of 18-42mm.
- •≥15mm non-aneurysmal aorta proximal and distal to the lesion.
- •Morphology suitable for endovascular repair.
- •For type B aortic dissection (TBAD) patient:
Exclusion Criteria
- •Patient with any contraindications mentioned in the Ankura™ Stent Graft System IFU:
- •Patients with acute systemic infection;
- •Patients who have had other devices implanted in the cardiovascular cavity, which will interfere with the placement of this device;
- •Patients with mesenteric blood flow mainly supplied by the inferior mesenteric artery;
- •Patients who have allergic reaction to the device;
- •Patients who are not suitable for endovascular repair in vascular morphology;
- •Patients who cannot tolerate contrast agents due to severe renal insufficiency;
- •Patients who are allergic to contrast agents;
- •Aneurysms neck with thrombus;
- •Non-aneurysmal aortic proximal neck length \<1.5cm;
Outcomes
Primary Outcomes
Incidence of major adverse events
Time Frame: Timeframe: within 30-day post-implantation
Incidence of major adverse events.
Freedom from stent graft-related events
Time Frame: Timeframe: within 12-month post-implantation
Freedom from stent graft-related events (12 months)