Type B Aortic DissectionEXTENSONCT06675617
EXtensive mulTilayer stEnt treatmeNt in Aortic disSectiOn
A study testing Allay Aortic Stent in people with Type B Aortic Dissection, run by Intressa Vascular SA at 21 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type B Aortic Dissection
- What is being tested?
- Allay Aortic Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 21 sitesin 8 countries
- Study dates
- 30 Oct 2024to Jun 2031
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
- Suspicion of bowel necrosis or irreversible visceral ischemia
- Stage 5 chronic kidney disease
- Life expectancy of less than 2 years due to any other medical condition than the dissection to be treated
- Active malignancy
- Known sensitivities or allergies to the device materials (including cobalt, chromium, nickel)
- Known sensitivities or allergies to contrast materials that cannot be pre-medicated
- Mycotic aortic aneurysm or active systemic infection that may place the patient at increased risk of endovascular infection
- American Society of Anaesthesiologists (ASA) class V (moribund patient not expected to live 24 hours with or without operation)
- Diagnosed or suspected congenital degenerative connective tissue disease (e.g., Marfan's, Loeys-Dietz or Ehlers-Danlos syndrome)
- Uncorrectable coagulopathy, bleeding diathesis or refusal of blood transfusion
- Any major cardiovascular or cerebrovascular ischemic event, including myocardial infarction or stroke, or treatment of such event, within 90 days prior to enrolment
- Any aortic-related interventional or surgical procedure within 30 days prior to enrolment
- Any planned aortic-related interventional or surgical procedure within 30 days after the study procedure
- Anatomical Exclusion Criteria:
- Aneurysmal dilatation of the false lumen defined as maximum transaortic diameter >55 mm in women or >60 mm in men in the thoraco-abdominal segment or >50 mm in women or >55 mm in men in the abdominal segment, measured inner-wall to inner-wall;
- Inadequate proximal landing zone for the stent graft, such zone being <20 mm long
- Inadequate proximal landing zone geometry for the Allay® Aortic Stent (e.g. aortic kink)
- Planned implantation of a stent graft with a distal diameter >38 mm or <20 mm
- Aorta or iliac anatomy not allowing the advancement of the delivery system
- Subject in whom the thoracic stent graft is either 1) not implanted in its intended position and/or 2) leads to any serious device complication, and/or who has 3) persistent static obstruction of the visceral or both renal arteries, prior to Allay® Aortic Stent implantation, will not be implanted with the Allay® Aortic Stent and will be withdrawn from the study
Trial locations and contacts
21 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
21 sites in 8 countries
Germany6 sites, 6 recruiting
- Recruiting
Uniklinik Düsseldorf
Düsseldorf, 40225
- Not yet recruiting
Universitätsmedizin Frankfurt
Frankfurt, 60590
- Recruiting
Universitätsklinikum Schleswig-Holstein
Kiel, 24105
- Recruiting
Universitätsklinikum Leipzig AöR
Leipzig, 04103
- Recruiting
TUM Klinikum rechts der Isar
München, 81675
- Recruiting
University Hospital of Münster
Münster, 48149
Poland6 sites, 6 recruiting
- Recruiting
Szpital Uniwersytecki nr 1 im. A. Jurasza w Bydgoszczy
Bydgoszcz, 85-094
- Recruiting
Uniwersytecki Szpital Kliniczny w Opolu
Opole, 45-401
- Recruiting
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, 61-848
- Recruiting
Kliniczny Szpital Wojewódzki Nr 2 im. Św. Jadwigi Królowej w Rzeszowie
Rzeszów, 35-301
- Recruiting
Wojskowy Instytut Medyczny, Państwowy Instytut Badawczy
Warsaw, 04-141
- Recruiting
Szpital Uniwersytecki im. Karola Marcinkowskiego w Zielonej Górze
Zielona Góra, 65-046
Belgium3 sites, 3 recruiting
- Recruiting
Ziekenhuis Oost-Limburg
Genk, 3600
- Recruiting
UZ Leuven
Leuven, 3000
- Recruiting
CHU Liège
Liège, 4000
France2 sites, 2 recruiting
- Not yet recruiting
CHU de Bordeaux (Hôpital Pellegrin)
Bordeaux
- Not yet recruiting
Hopital Européen Georges Pompidou AP-HP
Paris, 75015
Austria1 site, 1 recruiting
- Not yet recruiting
Paracelsus Medical University Salzburg
Salzburg, 5020
Bulgaria1 site, 1 recruiting
- Recruiting
Acibadem City Clinic University Hospital and Cardiovascular Center
Sofia, 1407
Serbia1 site, 1 recruiting
- Recruiting
University Clinical Centre of Serbia
Belgrade, 11000
Uzbekistan1 site
- Active, not recruiting
Republican Research Centre of Emergency Medicine
Tashkent, 100107
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Type B Aortic Dissection
- Being tested
- Allay Aortic Stent
- Keywords
- TBAD, Allay, aortic, dissection, type B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allay Aortic StentDevice
Endovascular treatment of an aortic dissection
| Study group | Role | What they receive |
|---|---|---|
| Allay Aortic Stent | Experimental | 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. Receives: Device: Allay Aortic Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (22)
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.
Measured: 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.
Measured: 30 days
Freedom from all-cause mortality;
The percentage of patients alive from any cause post-discharge at follow-up intervals.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessed at 12, 24, 36, 48, and 60 months, compared to the first post-operative CT scan.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start30 Oct 2024
- Primary completionJun 2027 (estimated)
- Study completionJun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type B Aortic DissectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intressa Vascular SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wolf-Hans Eilenberg, MD, PhD, FEBVS, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06675617
- Sponsor's protocol ID
- CP-P3-03-001
- Acronym
- EXTENSO
- Status last verified
- Sep 2026
- First submitted
- 30 Oct 2024
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided