Hemiarch vs Extended Arch in Type 1 Aortic Dissection
Hemiarch vs Extended Arch in Aortic Dissection - a SystemaTic Analysis by Randomized Trial (HEADSTART)
- Aortic Dissection
At a glance
- Phase
- Phase not stated
- Study type
- Interventional
- Sponsor
- Ottawa Heart Institute Research Corporation
- Enrolment target
- 50
- Started
- 30 July 2024
- Main results due
- 31 March 2027
- Study sites
- 5
- Registry updated
- 28 September 2026
Can you take part?
- Ages 18 years to 70 years.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full 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
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(5)
London Health Sciences Centre
London, Ontario, Canada
Recruiting
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
Recruiting
University Health Network
Toronto, Ontario, Canada
Recruiting
Montreal Heart Institute
Montreal, Quebec, Canada
Recruiting
Institut Universitaire De Cardiologie Et De Pneumologie de Québec
Québec, Quebec, Canada
Recruiting
Showing 5 of 5 sites. 5 of the 5 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT03885635. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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