Hemiarch versus extended arch repair for acute DeBakey type 1 aortic dissection
Official title: Hemiarch vs Extended Arch in Aortic Dissection - a SystemaTic Analysis by Randomized Trial (HEADSTART)
Run by Ottawa Heart Institute Research Corporation · NCT03885635 · Data updated 2026-11-12
This study will test whether an extended arch repair or the standard hemiarch repair leads to fewer deaths and fewer repeat operations in adults needing emergency surgery for acute DeBakey type 1 aortic dissection.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Ottawa Heart Institute Research Corporation Academic / other |
| Locations | 5 sites (London, Ontario and 4 other locations) |
| Status | Recruiting |
| Started | July 30, 2024 |
| Main results expected | March 31, 2027 |
| Study ends | March 31, 2027 |
| Registry record updated | September 28, 2026 |
| Trial ID | NCT03885635 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–70 presenting with acute DeBakey type 1 aortic dissection who are stable enough for surgery and where the operating surgeon believes both hemiarch and extended arch repair could be safe and effective.
✕Probably not a fit
Patients who are in shock (systolic BP <90 mm Hg), have prior sternotomy or thoracic endografts, very large arch diameters (>6 cm), severe organ failure, metastatic cancer, pregnancy, or other listed exclusion criteria are unlikely to qualify or benefit from randomization.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
HEADSTART is a prospective, open-label, randomized multicenter trial enrolling adults (18–70 years) who present with acute DeBakey type 1 aortic dissection and for whom the operating surgeon considers either hemiarch or extended arch repair feasible. Eligible patients are randomized to hemiarch repair or extended arch repair, with pre-operative, early post-operative, and regular long-term clinical follow-up and CT imaging collected over three years. Imaging is reviewed at a central core lab and clinical outcomes are entered into a centralized database to compare a composite endpoint of mortality and re-intervention.
Why it matters
Potential benefit: If successful, the trial could identify which surgical approach lowers death and the need for repeat procedures, guiding surgeons to improve survival and long-term aortic outcomes.
How similar studies have gone: Observational and cohort studies have suggested extended arch repairs may help with early malperfusion and long-term aortic remodeling, but results are mixed and randomized evidence is currently lacking.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
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
Study contacts
- Principal investigator: Munir Boodhwani, MD — Ottawa Heart Institute Research Corporation
- Study coordinator: Khatira Mehdiyeva
- Email: kmehdiyeva@ottawaheart.ca
- Phone: 613-696-7000
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Pregnancy-Related Aortic Dissection in China
This study looks at cases of aortic dissection that occur during pregnancy or shortly after, to understand outcomes for mothers and babies.
-
Ketorolac to improve outcomes and prognosis in Stanford Type A aortic dissection
This trial will test whether giving ketorolac around emergency surgery helps adults (18–65) with Stanford Type A aortic dissection recover better and have fewer complications over 90 days.
-
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.
-
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.
-
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.
-
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.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.