Evaluating TEVAR for uncomplicated aortic dissection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of thoracic endovascular aortic repair (TEVAR) in improving 5-year survival rates for patients with uncomplicated Stanford type-B aortic dissection (uTBAD). Participants will be randomly assigned to receive either standard medical therapy alone or standard medical therapy combined with TEVAR. The study aims to provide robust evidence regarding the potential benefits of TEVAR, addressing uncertainties in its use for uncomplicated cases. Secondary outcomes will assess aortic-related mortality, neurological events, quality of life, and healthcare costs.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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.

Exclusion Criteria:

* 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.

Where it's running

• Aalborg University Hospital
  Aalborg, Denmark Recruiting
• Aarhus University Hospital
  Aarhus, Denmark Recruiting
• Copenhagen University Hospital, Rigshospital
  Copenhagen, Denmark Recruiting
• Odense University Hospital
  Odense, Denmark Recruiting
• Helsinki University Hospital
  Helsinki, Finland Recruiting
• Tampere University Hospital
  Tampere, Finland Recruiting

Study contacts

• Principal investigator: Jacob W Budtz-Lilly, MD PhD — Aarhus University Hospital
• Study coordinator: Jacob W Budtz-Lilly, MD PhD
• Email: jacoblilly@clin.au.dk
• Phone: 45 28147705

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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  Recruiting Phase 3 The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Nanjing, Jiangsu · NCT06968806

• WeFlow-EndoPatch for Distal Aortic Tear Repair in Chronic Dissection

  This study tests whether the WeFlow-EndoPatch Aortic Endovascular Patch can safely and effectively seal distal tears in chronic aortic dissection compared with standard treatment.

  Recruiting Hangzhou Endonom Medtech Co., Ltd. · Beijing, Beijing Municipality · NCT06945809

• Aortic arch single-branch covered stent graft for treating aortic dissection

  This trial tests a single-branch covered stent graft in adults with Stanford Type B aortic dissection who need revascularization of the left subclavian artery.

  Recruiting Lifetech Scientific (Shenzhen) Co., Ltd. · Changsha · NCT06915545

• Multicenter study on acute type A aortic dissection

  This study is trying to learn more about patients with acute type A aortic dissection by looking at their health details, surgeries, and recovery to see what affects their outcomes.

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• Shape‑memory polymer to seal the false lumen and prevent aortic enlargement

  This trial will try a shape‑memory polymer implant to seal the false lumen and stop aortic growth in adults with type B dissection or treated type A dissection who need false lumen repair.

  Recruiting at 2 sites Shape Memory Medical, Inc. · Auckland and 1 other locations · NCT06550986

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.