Recruiting

Hemiarch vs. Extended Arch

Sponsor:

Ottawa Heart Institute Research Corporation

Code:

NCT03885635

Conditions

Aortic Dissection

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Hemiarch repair

Extended arch repair

Study Details

Brief 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.

Conditions

Aortic Dissection

Study ID

NCT03885635

Start date

Jul 30, 2024

Status verified date

Aug, 2025

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Hemiarch repair

Standard hemiarch repair with open distal anastomosis in the proximal arch without replacement of the head vessels.

active comparator: Extended arch repair

Ascending aortic and arch replacement with or without head vessel re-implantation and single TEVAR device placement within 1 week.

Interventions

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.

Primary outcome measure

  • Number of patients experiencing a composite end-point of mortality or re-intervention [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Khatira Mehdiyeva

613-696-7000kmehdiyeva@ottawaheart.ca

Alice Black

403-389-8958AlBlack@ottawaheart.ca

Locations

London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A5A5

Contacts

Stephen Mardell

5196858500Stephen.Mardell@lhsc.on.ca

Principal Investigator:

Michael Chu, MD

University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Contacts

Waleed Alnimr

416 340 4800Waleed.AlNimr@uhn.ca

Principal Investigator:

Maral Ouzounian, MD

Montreal Heart Institute

Recruiting

Montreal, Quebec, Canada, H1T 1C8

Contacts

Asma Hamlili

514-376-3330asma.hamlili@icm-mhi.org

Alexandre Bergeron

514-376-3330alexandre.bergeron.icm@icm-mhi.org

Principal Investigator:

Philippe Demers, MD

Institut Universitaire De Cardiologie Et De Pneumologie de Québec

Recruiting

Québec, Quebec, Canada, G1V 4G5

Contacts

Annie Bergeron

418-656-8711annie.bergeron@criucpq.ulaval.ca

Principal Investigator:

François Dagenais, MD

More Information

Sponsor

Ottawa Heart Institute Research Corporation

Last update posted

Sep 22, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Heart Institute Research Corporation on 2025-09-22.