EXtensive mulTilayer stEnt treatmeNt in Aortic disSectiOn

Intressa Vascular SA72 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type B Aortic Dissection

Interventions

Allay Aortic StentDEVICE

Endovascular treatment of an aortic dissection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 * 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

Locations (21)

Paracelsus Medical University Salzburg

Salzburg, Austria

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

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

Secondary Outcomes

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

Central Contacts

Virginie Martin

CONTACT

+3281 71 99 41 virginie.martin@intressavascular.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Ziekenhuis Oost-Limburg

Genk, Belgium

RECRUITING

UZ Leuven

Leuven, Belgium

RECRUITING

CHU Liège

Liège, Belgium

RECRUITING

Acibadem City Clinic University Hospital and Cardiovascular Center

Sofia, Bulgaria

RECRUITING

CHU de Bordeaux (Hôpital Pellegrin)

Bordeaux, France

NOT_YET_RECRUITING

Hopital Européen Georges Pompidou AP-HP

Paris, France

NOT_YET_RECRUITING

Uniklinik Düsseldorf

Düsseldorf, Germany

RECRUITING

Universitätsmedizin Frankfurt

Frankfurt, Germany

NOT_YET_RECRUITING

Universitätsklinikum Schleswig-Holstein

Kiel, Germany

RECRUITING

...and 11 more locations

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.