Hemiarch vs Extended Arch in Type 1 Aortic Dissection (HEADSTART)

  • STATUS
    Recruiting
  • End date
    Mar 31, 2025
  • participants needed
    182
  • sponsor
    University of Calgary
Updated on 7 February 2022
neurological monitoring

Summary

HEADSTART is a prospective, open-label, non-blinded, multicenter, randomized controlled trial that compares a composite of mortality and re-intervention in patients undergoing hemiarch and extended arch repair for acute DeBakey type 1 aortic dissection. Eligible patients will be randomized to one or the other surgical strategy and clinical and imaging outcome data will be collected over a 3 year follow up period.

Description

DeBakey Type 1 aortic dissections continue to have high operative mortality and morbidity and there is equipoise in available literature with regards to the best operative strategy and patient selection criteria. Hemiarch repair is current standard of care in most centers but extended arch repair is gaining popularity aiming to address early post-operative malperfusion and improve long term aortic remodeling.

HEADSTART is a randomized controlled prospective trial of patients presenting to participating institutes with acute DeBakey 1 aortic dissection. Patients will be enrolled and randomized into one of two groups - 'hemiarch repair' and 'extended arch repair'. Pre-operative, early post-operative and long term follow clinical and CT imaging data will be collated on a centralized database and at a core lab respectively.

Details
Condition Aortic Dissection
Treatment Hemiarch repair, Extended arch repair
Clinical Study IdentifierNCT03885635
SponsorUniversity of Calgary
Last Modified on7 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Emergent surgical repair of Acute DeBakey Type 1 aortic dissection
Age >18 years and <70 years
Operating surgeon believes that both surgeries could be safe and effective

Exclusion Criteria

Hemodynamic instability/shock defined as systolic BP < 90 mm Hg
Previous cardiac surgery with sternotomy or thoracic endograft placement
Aortic arch diameter > 6cm in which a concomitant arch replacement is judged necessary
Procedures deemed to be "salvage operations" where the patient is unlikely to survive hospital discharge
GCS < 8 for more than 6 hours
History of cirrhosis
History of chronic renal failure (baseline eGFR < 50)
Metastatic malignancy
Pregnancy
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