Scandinavian trial of Uncomplicated Aortic Dissection Therapy

Phase 3

• Conditions: aortic tear; Dissection; 10002363; inner wall tear aorta

• Registration Number: NL-OMON56870
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 July 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

- Patients aged 18 or greater at the time of informed consent signature
- Patients with an acute (< 14 days) or subacute (<90 days) uncomplicated type
B dissection.

Exclusion Criteria

·Patients with no signed informed consent.
·Patients presenting with a complicated type B aortic dissection according to
the above definition.
·Patients previously treated in their descending aorta, either open surgery or
TEVAR.
·Patients with pre-existing thoracoabdominal aortic aneurysm.
· Subjects with other aortic pathology with an indication for intervention that
requires TEVAR.
· Patients with traumatic aortic dissections.
· Patients with an established connective tissue disease at the time of
randomization, including but not limited to Marfans and Loeys-Dietz syndrome.
- Patients with a clinically estimated life expectancy < 2 years.
- Patients with dementia.
·Pregnant or nursing participants.
- Patients with current sepsis.
- Patients currently participating in other clinical interventional trials.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary analysis will be based on the intention to treat principle using<br /><br>the full analysis set and all-cause mortality events as confirmed by the local<br /><br>investigator. The primary objective of the study is to determine the<br /><br>superiority of TEVAR versus SMT in reducing the incidence of all-cause<br /><br>mortality. </p><br>