Hemiarch vs Extended Arch in Type 1 Aortic Dissection

Recruiting now · Not applicable

Conditions studied: Aortic Dissection

In brief

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.

Key facts

Study ID: NCT03885635
Run by: Ottawa Heart Institute Research Corporation
People needed: 50
Starts: 2024-07-30
Expected to finish: 2027-03-31
Last updated by the study team: 2025-09-22

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

London Health Sciences Centre — London, Ontario, Canada (enrolling)
University Health Network — Toronto, Ontario, Canada (enrolling)
Montreal Heart Institute — Montreal, Quebec, Canada (enrolling)
Institut Universitaire De Cardiologie Et De Pneumologie de Québec — Québec, Quebec, Canada (enrolling)

Full record on ClinicalTrials.gov

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