Health Trials

EXtensive mulTilayer stEnt treatmeNt in Aortic disSectiOn

ConditionType B Aortic Dissection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIntressa Vascular SA

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Allay Aortic Stent

    Device

    Endovascular treatment of an aortic dissection

Treatment groups

72 Participants
are divided into 1 treatment group
Group A: Allay Aortic StentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

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
3

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
4

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Intressa Vascular SA

Lead sponsor

Source ClinicalTrials.gov
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