NCT05215587

Brief Summary

The introduction of thoracic endovascular aortic repair (TEVAR) in 1994 has radically changed the treatment of thoracic aortic pathology, and TEVAR is now the recommended therapy for "complicated" TBADs and other thoracic aorta diseases. To date, the use of TEVAR in the treatment of "uncomplicated" dissections (uTBAD) is uncertain, although it is presumed that a prophylactic procedure can prevent later complex surgery and early death. Several analyses have found that TEVAR confers improved aortic remodeling and possibly survival, although these were underpowered for this specific outcome. In addition, there are several reports regarding the uncertain benefit or harm of this intervention in the vascular surgery community. Put another way, there is equipoise, and the need for robust evidence in the form of a randomized clinical trial has been clearly iterated by the European Society of Vascular Surgery. This randomized, open-label, two-armed controlled study directly addresses this question of whether TEVAR alters 5-year survival among patients with an uTBAD. Patients will be randomized to either standard medical therapy (SMT) alone or TEVAR in addition to SMT. The primary outcome is 5-year survival, while secondary outcomes include aortic-related mortality, neurological events, quality of life, costs, re interventions and readmissions. in addition, subgroup analyses based on the extent of treatment. Sample size calculations based on previous reports indicate the need to include approximately 554 patients. Patients will be recruited from multiple centres in Scandinavia. Based on the population (24 million) and incidence of uTBAD (approximately 480 per year), and depending on the total number of participating centres, a conservative estimate of two to three years is required for enrolment.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
554

participants targeted

Target at P75+ for not_applicable

Timeline
57mo left

Started May 2023

Longer than P75 for not_applicable

Geographic Reach
6 countries

28 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress39%
May 2023Dec 2030

First Submitted

Initial submission to the registry

January 17, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 31, 2022

Completed
1.3 years until next milestone

Study Start

First participant enrolled

May 24, 2023

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

August 11, 2025

Status Verified

March 1, 2025

Enrollment Period

3.6 years

First QC Date

January 17, 2022

Last Update Submit

August 8, 2025

Conditions

Aortic Dissection

Keywords

Aortic; dissection; TEVAR; endovascular; vascular

Outcome Measures

Primary Outcomes (1)

  • Survival

    Overall survival

    Five years

Secondary Outcomes (6)

  • Aortic-related mortality

    Five years

  • Neurological injury

    Five years

  • Reintervention

    Five years

  • EuroQOL-5D-5L

    Five years

  • Hospital Anxiety and Depression Score

    Five years

  • +1 more secondary outcomes

Study Arms (2)

Medical Therapy

NO INTERVENTION

Patients will be treated with standard medical therapy, i.e., antihypertensives, pulse-rate regulators, and pain medication.

Stent Therapy

ACTIVE COMPARATOR

Patients will be treated with both standard medical therapy, in addition to placement of a thoracic endovascular aortic repair stent graft.

Device: TEVAR

Interventions

TEVARDEVICE

A TEVAR stent graft will be placed in the descending aorta in order to cover the primary entry of the dissection.

Also known as: Thoracic aortic endovascular repair stent graft
Stent Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All subjects, aged 18 or greater at the time of informed consent, admitted or referred to the participating vascular surgery site with an uTBAD of less than four weeks duration.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (28)

Aalborg University Hospital

Aalborg, Denmark

RECRUITING

Aarhus University Hospital

Aarhus, 8200, Denmark

RECRUITING

Copenhagen University Hospital, Rigshospital

Copenhagen, Denmark

RECRUITING

Odense University Hospital

Odense, Denmark

RECRUITING

Helsinki University Hospital

Helsinki, Finland

RECRUITING

Kuopio University Hospital

Kuopio, Finland

NOT YET RECRUITING

Oulu University Hospital

Oulu, Finland

NOT YET RECRUITING

Tampere University Hospital

Tampere, Finland

RECRUITING

Turku University Hospital

Turku, Finland

RECRUITING

Landspitali University Hospital

Reykjavik, Iceland

RECRUITING

Amsterdam University Medical Center (AUMC)

Amsterdam, Netherlands

NOT YET RECRUITING

University Medical Center Groningen (UMCG)

Groningen, Netherlands

NOT YET RECRUITING

Leiden University Medical Center (LUMC)

Leiden, Netherlands

RECRUITING

Maastricht University Medical Center (MUMC)

Maastricht, Netherlands

NOT YET RECRUITING

Radboud University Medical Center (Radboudumc)

Nijmegen, Netherlands

NOT YET RECRUITING

Erasmus Medical Center (EMC)

Rotterdam, Netherlands

NOT YET RECRUITING

University Medical Center Utrecht (UMCU)

Utrecht, Netherlands

NOT YET RECRUITING

Haukeland University Hospital

Bergen, Norway

RECRUITING

Oslo University Hospital

Oslo, Norway

RECRUITING

University Hospital Nord

Tromsø, Norway

RECRUITING

St Olavs Hospital

Trondheim, Norway

RECRUITING

Sahlgrenska University Hospital

Gothenburg, Sweden

RECRUITING

Linköping University Hospital

Linköping, Sweden

RECRUITING

Skånes University Hospital

Malmo, Sweden

RECRUITING

Örebro University Hospital

Örebro, Sweden

ACTIVE NOT RECRUITING

Karolinska University Hospital

Stockholm, Sweden

RECRUITING

Sodersjukhuset

Stockholm, Sweden

RECRUITING

Uppsala University Hospital

Uppsala, Sweden

RECRUITING

Related Publications (1)

  • Rudolph C, Lindberg BR, Resch T, Mani K, Bjorkman P, Laxdal EH, Stovring H, Beck HM, Eriksson G, Budtz-Lilly J. Scandinavian trial of uncomplicated aortic dissection therapy: study protocol for a randomized controlled trial. Trials. 2023 Mar 23;24(1):217. doi: 10.1186/s13063-023-07255-7.

    PMID: 36949478BACKGROUND

Related Links

MeSH Terms

Conditions

Aortic Dissection

Interventions

Endovascular Aneurysm Repair

Condition Hierarchy (Ancestors)

Dissection, Blood VesselAneurysmVascular DiseasesCardiovascular DiseasesAcute Aortic SyndromeAortic Diseases

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeBlood Vessel Prosthesis ImplantationVascular GraftingMinimally Invasive Surgical ProceduresProsthesis Implantation

Study Officials

  • Jacob W Budtz-Lilly, MD PhD

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

  • Kevin Mani, MD PhD

    Uppsala University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacob W Budtz-Lilly, MD PhD

CONTACT

45 28147705jacoblilly@clin.au.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Data are collected and stored using the Research Electronic Data Capture (REDCap) software. Overall access is granted only to the Data and Safety Monitoring Committee and the Trial Steering Committee.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The trial is a randomized, open label, clinical trial with parallel assignment of patients in multiple centres in Denmark, Sweden, Norway, Finland, Iceland, New Zealand, and the Netherlands. Recruited subjects will undergo stratified randomization based on the centre to either a control or intervention arm.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2022

First Posted

January 31, 2022

Study Start

May 24, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2030

Last Updated

August 11, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

There is no plan to share individual patient data with other researchers outside the trial.

Locations

DK(4)FI(5)NO(4)SE(7)NL(7)IC(1)