Hemiarch vs Extended Arch in Type 1 Aortic Dissection

NCT03885635 · tracked via the Priya Life Science Canada tracker

Sponsor

Ottawa Heart Institute Research Corporation

Phase

Not applicable

Started

2024-07-30

Last updated

2026-09-28

Condition(s) studied

Aortic Dissection

Investigational drug(s) / intervention(s)

Hemiarch repairExtended arch repair

Hemiarch repair: 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: 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.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

70 Years

Healthy volunteers

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

Primary outcome measure(s)

Number of patients experiencing a composite end-point of mortality or re-intervention — 3 years
Compare the proportion of patients between the two groups who over a 3 year follow up period attain a composite clinical end-point of 1) mortality, 2) late aortic re-intervention, either surgical or endovascular (\> 30 days from index procedure) or 3) early (\< 30 days from index procedure) re-intervention for branch malperfusion

Trial sites (5)

Facility	City	Region	Status
London Health Sciences Centre	London	Ontario	Recruiting
University of Ottawa Heart Institute	Ottawa	Ontario	Recruiting
University Health Network	Toronto	Ontario	Recruiting
Montreal Heart Institute	Montreal	Quebec	Recruiting
Institut Universitaire De Cardiologie Et De Pneumologie de Québec	Québec	Quebec	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03885635 on ClinicalTrials.gov ↗ ← All trials in Canada