An interventional study of Allay Aortic Stent in Type B Aortic Dissection, sponsored by Intressa Vascular SA. Recruiting at 21 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Intressa Vascular SA · Not applicable, Interventional, and Treatment
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.
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.
This is the only study on the registry with Intressa Vascular SA as lead sponsor.
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Exclusion Criteria:
General Exclusion Criteria:
Medical Exclusion Criteria:
Anatomical Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A covered thoracic stent graft is first deployed in supraceliac position as per standard of care then followed by the implantation of the Allay® Aortic Stent deployed from within the stent graft, extending below the celiac trunk to the end of the dissected aorta, typically the aortoiliac bifurcation.
Device: Allay Aortic Stent
Endovascular treatment of an aortic dissection
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
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.
Time frame: 12 months
Percentage of Participants with Successful Technical Performance of the Allay® Aortic Stent Implantation
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.
Time frame: At index procedure
Incidence of Major Adverse Events (MAE) within 30 Days After Allay® Aortic Stent Implantation
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.
Time frame: 30 days
Freedom from all-cause mortality;
The percentage of patients alive from any cause post-discharge at follow-up intervals.
Time frame: Immediately at discharge and subsequent follow-up visits, at 30 days, 12, 24, 36, 48 and 60 months
Freedom from Dissection-Related Mortality
The percentage of patients who are alive and free from dissection-related mortality, if known.
Time frame: Immediately at discharge and subsequent follow-up visits at 30 days, 12, 24, 36, 48, and 60 months.
Freedom from Readmission (Post-Discharge)
The percentage of patients who have not been readmitted to the hospital post-discharge.
Time frame: Subsequent follow-up visits at 30 days, 12, 24, 36, 48, and 60 months.
Freedom from Aorta-Related Reintervention
The percentage of patients who have not required a reintervention related to the aorta, including details on the type and frequency if any.
Time frame: Immediately at discharge and subsequent follow-up visits at 30 days, 12, 24, 36, 48, and 60 months.
Freedom from Open Conversion
The percentage of patients who have not required conversion to open surgical intervention.
Time frame: Immediately at discharge and subsequent follow-up visits at 30 days, 12, 24, 36, 48, and 60 months.
Freedom from New Ischemia
The percentage of patients free from new ischemic events identified post-intervention.
Time frame: 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
The percentage of patients who have not required reintervention related to side branches.
Time frame: Immediately at discharge and subsequent follow-up visits at 30 days, 12, 24, 36, 48, and 60 months.
Aortic rupture
Incidence of aortic rupture observed through CT imaging post-intervention.
Time frame: 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
Assessment of changes in the patency of major aortic branches post-intervention.
Time frame: 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
Evaluation of changes in the patency of major descending aortic branches covered by the Allay® Aortic Stent.
Time frame: 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
Assessment of device deficiencies observed through CT imaging, including loss of patency, kink, collapse, migration, and overlap separation.
Time frame: Assessed at discharge (or within 30 days from the index procedure) and compared to the pre-operative CT scan.
Aortic growth
Measurement of aortic growth over time as assessed through CT imaging.
Time frame: 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
Incidence of aortic rupture observed during follow-up CT imaging.
Time frame: 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
Occurrence of any new dissection or extension of existing dissection observed in follow-up CT scans.
Time frame: 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
Identification of fistula formation during follow-up CT imaging assessments.
Time frame: 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
Measurement of changes in the true lumen, false lumen, and transaortic diameters through follow-up CT imaging.
Time frame: 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
Evaluation of changes in the patency of major aortic branches during follow-up imaging.
Time frame: 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
Observation of changes in the patency of major descending aortic branches covered by the Allay® Aortic Stent.
Time frame: 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
Assessment of false lumen perfusion and patency across all treated segments.
Time frame: 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
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.
Time frame: Assessed at 12, 24, 36, 48, and 60 months, compared to the first post-operative CT scan.
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Started Oct 2024 (actual). Primary completion is estimated for Jun 2027, 32 months after the start.
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