A Clinical Study to Evaluate the Effectiveness and Safety of the Allay® Aortic Stent as Adjunctive Endovascular Treatment of Type B Aortic Dissection in Patients Eligible for Thoracic Endovascular Repair With Stent Grafts
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Type B Aortic Dissection
- Sponsor
- Intressa Vascular SA
- Enrollment
- 72
- Locations
- 10
- Primary Endpoint
- Freedom from aortic growth requiring secondary reintervention, including open conversion, or aortic rupture in the region treated by the Allay® Aortic Stent at 12 months
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
Brief Summary
This clinical trial is a prospective, multicenter, open label study designed to evaluate the effectiveness and the safety of the Allay® Aortic Stent as adjunctive endovascular treatment of Type B aortic dissection in patients eligible for thoracic endovascular aortic repair with stent grafts.
Detailed Description
Thoracic endovascular repair (TEVAR) with stent grafts is recommended for patients with acute complicated or high-risk type B aortic dissection (TBAD) as part of standard of care per current medical guidelines. Although the benefits of TEVAR with stent grafts are well established, there remains a significant risk of late complications, including aortic growth requiring reinterventions, or progression and/or rupture. In the present clinical investigation, the investigational procedure of adjunctive thoracic stent graft extension with the Allay® Aortic Stent will consist of the placement of a CE-marked Thoracic Stent Graft in the descending thoracic aorta (proximal to the celiac trunk) followed by the implantation of the Allay® Aortic Stent as adjunctive treatment of TBAD. The study objective is to demonstrate that the Allay® Aortic Stent, used as adjunctive endovascular treatment of Type B aortic dissection in patients eligible for thoracic endovascular aortic repair with stent grafts, results in a low rate of aortic growth requiring secondary reintervention, including open conversion, or aortic rupture in the treated abdominal segment at 12 months. The study will also allow to evaluate the incidence of Major Adverse Events (MAE) following TEVAR, at 30 days post-implantation of the Allay® Aortic Stent. Based on available data on similar devices, the objective performance goal is set to an expected proportion of 85% freedom from aortic growth requiring secondary reintervention or aortic rupture of the abdominal segment at 12 months.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Have a type B aortic dissection extending to the celiac trunk or beyond
- •Are eligible for thoracic endovascular treatment with stent grafts as per local guidelines, and physician's decision
- •Have been elected for treatment with commercially available stent graft as per their IFU within 90 days of dissection symptoms onset
Exclusion Criteria
- •General Exclusion Criteria:
- •Age \< 18 years
- •Pregnant, breast-feeding or planning on becoming pregnant during the entire duration of the study
- •Unable to provide written informed consent
- •Unable or unwilling to comply with the requirements of the study protocol
- •Taking part already in an investigational device or drug study that could interfere with the outcomes being studied
- •Active drug addiction or known history of drug abuse within one year of treatment
- •Medical Exclusion Criteria:
- •Aortic rupture, free or contained including haemothorax, increasing periaortic hematoma, or mediastinal hematoma
- •Aortic fistula
Outcomes
Primary Outcomes
Freedom from aortic growth requiring secondary reintervention, including open conversion, or aortic rupture in the region treated by the Allay® Aortic Stent at 12 months
Time Frame: 12 months
An aortic growth requiring reintervention in the region treated with the Allay® Aortic Stent is defined as an increase in maximum aortic transverse diameter \>10mm at 12 months relative to the first post-operative CT scan done at discharge and not later than 30 days.
Secondary Outcomes
- Percentage of Participants with Successful Technical Performance of the Allay® Aortic Stent Implantation(At index procedure)
- Incidence of Major Adverse Events (MAE) within 30 Days After Allay® Aortic Stent Implantation(30 days)
- Freedom from all-cause mortality;(Immediately at discharge and subsequent follow-up visits, at 30 days, 12, 24, 36, 48 and 60 months)
- Freedom from Dissection-Related Mortality(Immediately at discharge and subsequent follow-up visits at 30 days, 12, 24, 36, 48, and 60 months.)
- Freedom from Readmission (Post-Discharge)(Subsequent follow-up visits at 30 days, 12, 24, 36, 48, and 60 months.)
- Freedom from Aorta-Related Reintervention(Immediately at discharge and subsequent follow-up visits at 30 days, 12, 24, 36, 48, and 60 months.)
- Freedom from Open Conversion(Immediately at discharge and subsequent follow-up visits at 30 days, 12, 24, 36, 48, and 60 months.)
- Freedom from New Ischemia(Immediately at discharge and subsequent follow-up visits at 30 days, 12, 24, 36, 48, and 60 months.)
- Freedom from Reintervention Related to Side Branches(Immediately at discharge and subsequent follow-up visits at 30 days, 12, 24, 36, 48, and 60 months.)
- Aortic rupture(Assessed at discharge or not later than 30 days from index procedure, and then compared to pre-operative CT scan)
- Percentage of Participants with Patent Major Aortic Branches Post-Allay® Aortic Stent Implantation(Assessed at discharge (or within 30 days from the index procedure) and compared to the pre-operative CT scan.)
- Percentage of Participants with Patent Major Descending Aortic Branches Covered by the Allay® Aortic Stent(Assessed at discharge (or within 30 days from the index procedure) and compared to the pre-operative CT scan.)
- Percentage of Participants with Device Deficiencies Detected by CT Imaging Post-Allay® Aortic Stent Implantation(Assessed at discharge (or within 30 days from the index procedure) and compared to the pre-operative CT scan.)
- Aortic growth(Assessed at 12, 24, 36, 48 and 60 months, then compared to first post-operative CT scan done at discharge and not later than 30 days from index procedure)
- Aortic Rupture(Assessed at 12, 24, 36, 48, and 60 months, compared to the first post-operative CT scan done at discharge.)
- New Dissection or Extension of Dissection(Assessed at 12, 24, 36, 48, and 60 months, compared to the first post-operative CT scan.)
- Percentage of Participants with Fistula Formation Detected on Follow-Up CT Imaging(Assessed at 12, 24, 36, 48, and 60 months, compared to the first post-operative CT scan.)
- Change in True Lumen, False Lumen, and Transaortic Diameters(Assessed at 12, 24, 36, 48, and 60 months, compared to the first post-operative CT scan.)
- Percentage of Participants with Maintained Patency in Major Aortic Branches on Follow-Up Imaging(Assessed at 12, 24, 36, 48, and 60 months, compared to the first post-operative CT scan.)
- Percentage of Participants with Maintained Patency in Major Descending Aortic Branches Covered by the Allay® Aortic Stent on Follow-Up Imaging(Assessed at 12, 24, 36, 48, and 60 months, compared to the first post-operative CT scan.)
- Percentage of Participants with Maintained False Lumen Perfusion and Patency in All Treated Segments on Follow-Up Imaging(Assessed at 12, 24, 36, 48, and 60 months, compared to the first post-operative CT scan.)
- Percentage of Participants with Device Deficiencies on Follow-Up Imaging(Assessed at 12, 24, 36, 48, and 60 months, compared to the first post-operative CT scan.)