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RECRUITING Not applicable ClinicalTrials.gov

Hemiarch vs Extended Arch in Type 1 Aortic Dissection

Sponsor: Ottawa Heart Institute Research Corporation • ClinicalTrials.gov ID: NCT03885635

Registry updated: 2026-09-28
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Description

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.

Interventions

  • Hemiarch repair (Procedure)
    Current standard of surgical repair consisting of ascending aortic replacement with open distal anastomosis at level of proximal arch under a period of hypothermic circulatory arrest . No surgical or endovascular intervention is carried out in the mid arch or descending aorta. Intra-operative management, including cannulation, cardioplegia, cerebral perfusion technique, and neurologic monitoring will be done according to each institution's current standard of practice.
  • Extended arch repair (Procedure)
    Surgical replacement of the ascending aorta along with intervention on the arch and descending aorta. Techniques for distal aspect of extended arch technique include but are not limited to total arch replacement along with TEVAR, Frozen Elephant Trunk procedure or surgical proximal arch replacement with bare metal stents in arch and descending aorta. Intra-operative management, including cannulation, cardioplegia, cerebral perfusion technique, and neurologic monitoring will be done according to each institution's current standard of practice.

Eligibility criteria

Inclusion Criteria 1. Emergent surgical repair of Acute DeBakey Type 1 aortic dissection 2. Age \>18 years and \<70 years 3. Operating surgeon believes that both surgeries could be safe and effective Exclusion Criteria 1. Hemodynamic instability/shock defined as systolic BP \< 90 mm Hg 2. Previous cardiac surgery with sternotomy or thoracic endograft placement 3. Aortic arch diameter \> 6cm in which a concomitant arch replacement is judged necessary 4. Procedures deemed to be "salvage operations" where the patient is unlikely to survive hospital discharge. 5. GCS \< 8 for more than 6 hours 6. History of cirrhosis. 7. History of chronic renal failure (baseline eGFR \< 50) 8. Metastatic malignancy 9. Pregnancy

Conditions

Aortic Dissection

Locations

  • London Health Sciences Centre — London, Ontario, Canada
  • University of Ottawa Heart Institute — Ottawa, Ontario, Canada
  • University Health Network — Toronto, Ontario, Canada
  • Montreal Heart Institute — Montreal, Quebec, Canada
  • Institut Universitaire De Cardiologie Et De Pneumologie de Québec — Québec, Quebec, Canada
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record