Type B Aortic Dissection
Conditions
Keywords
TBAD, Allay, aortic, dissection, type B
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 an established first-line treatment for acute complicated TBAD. In uncomplicated high-risk TBAD, TEVAR may be considered in selected patients based on patient characteristics, anatomy and clinical judgement, with uncertainty remaining regarding optimal patient selection, timing and long-term outcome. Although the benefits of TEVAR are well established in acute complicated TBAD, there remains significant risk of aneurysmal degeneration and late aortic complications associated with distal dissection left untreated, including aortic growth requiring reinterventions, or progression and/or rupture. The present clinical investigation will enrol patients after the decision for proximal TEVAR has been made as per standard of care. The investigational procedure of adjunctive thoracic stent graft extension with the Allay® Aortic Stent will be performed after the placement of a CE-marked Thoracic Stent Graft in the descending thoracic aorta (proximal to the celiac trunk). 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.
Interventions
DEVICEAllay Aortic Stent
Endovascular treatment of an aortic dissection
Sponsors
Intressa Vascular SA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants with Successful Technical Performance of the Allay® Aortic Stent Implantation | At index procedure | Technical success of the implantation of the Allay® Aortic Stent will be assessed at index procedure as the composite endpoint of the following: * Successful delivery to the intended implantation site and withdrawal of the delivery system; * Accurate deployment of the Allay® Aortic Stent defined as appropriate proximal landing in the stent graft and distal landing in descending aorta; * Absence of unexpected adverse effect on the stent graft, additional procedure related to the device, procedure, or withdrawal of the delivery system. |
| Incidence of Major Adverse Events (MAE) within 30 Days After Allay® Aortic Stent Implantation | 30 days | The safety endpoint will be assessed as the freedom from Major Adverse Events (MAE) at 30 days, defined as the composite endpoint of the following new-onset adverse events: * Myocardial infarction; * Renal failure requiring permanent dialysis; * Bowel ischemia requiring surgical intervention; * Disabling stroke; * Paraplegia or paraparesis; * Limb ischemia; * Death. |
| Freedom from all-cause mortality; | Immediately at discharge and subsequent follow-up visits, at 30 days, 12, 24, 36, 48 and 60 months | The percentage of patients alive from any cause post-discharge at follow-up intervals. |
| Freedom from Dissection-Related Mortality | Immediately at discharge and subsequent follow-up visits at 30 days, 12, 24, 36, 48, and 60 months. | The percentage of patients who are alive and free from dissection-related mortality, if known. |
| Freedom from Readmission (Post-Discharge) | Subsequent follow-up visits at 30 days, 12, 24, 36, 48, and 60 months. | The percentage of patients who have not been readmitted to the hospital post-discharge. |
| Freedom from Aorta-Related Reintervention | Immediately at discharge and subsequent follow-up visits at 30 days, 12, 24, 36, 48, and 60 months. | The percentage of patients who have not required a reintervention related to the aorta, including details on the type and frequency if any. |
| Freedom from Open Conversion | Immediately at discharge and subsequent follow-up visits at 30 days, 12, 24, 36, 48, and 60 months. | The percentage of patients who have not required conversion to open surgical intervention. |
| Freedom from New Ischemia | Immediately at discharge and subsequent follow-up visits at 30 days, 12, 24, 36, 48, and 60 months. | The percentage of patients free from new ischemic events identified post-intervention. |
| 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. | The percentage of patients who have not required reintervention related to side branches. |
| Aortic rupture | Assessed at discharge or not later than 30 days from index procedure, and then compared to pre-operative CT scan | Incidence of aortic rupture observed through CT imaging post-intervention. |
| 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. | Assessment of changes in the patency of major aortic branches post-intervention. |
| 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. | Evaluation of changes in the patency of major descending aortic branches covered by the Allay® Aortic Stent. |
| 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. | Assessment of device deficiencies observed through CT imaging, including loss of patency, kink, collapse, migration, and overlap separation. |
| 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 | Measurement of aortic growth over time as assessed through CT imaging. |
| Aortic Rupture | Assessed at 12, 24, 36, 48, and 60 months, compared to the first post-operative CT scan done at discharge. | Incidence of aortic rupture observed during follow-up CT imaging. |
| New Dissection or Extension of Dissection | Assessed at 12, 24, 36, 48, and 60 months, compared to the first post-operative CT scan. | Occurrence of any new dissection or extension of existing dissection observed in follow-up CT scans. |
| 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. | Identification of fistula formation during follow-up CT imaging assessments. |
| 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. | Measurement of changes in the true lumen, false lumen, and transaortic diameters through follow-up CT imaging. |
| 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. | Evaluation of changes in the patency of major aortic branches during follow-up imaging. |
| 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. | Observation of changes in the patency of major descending aortic branches covered by the Allay® Aortic Stent. |
| 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. | Assessment of false lumen perfusion and patency across all treated segments. |
| 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. | Identification of device deficiencies through CT imaging, including but not limited to stent integrity, patency loss (kink, collapse), migration, separation, and endoleak Types I or III. |
Countries
Austria, Belgium, Bulgaria, France, Germany, Poland, Serbia, Uzbekistan
Contacts
CONTACTVirginie Martin
PRINCIPAL_INVESTIGATORWolf-Hans Eilenberg, MD, PhD, FEBVS
Medical University of Vienna
Outcome results
None listed