Hemiarch vs Extended Arch in Type 1 Aortic Dissection

NCT03885635 | Recruiting DMC

• 1 other identifier: HEADSTART
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (1)

• Number of patients experiencing a composite end-point of mortality or re-intervention

  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

  3 years

Secondary Outcomes (6)

• Number of patients achieving complete false lumen thrombosis on CT imaging

  3 years

• Delta change in the ratio of true lumen to total aortic area (TL: Ao)

  1 month

• Delta change in maximum cross-sectional descending thoracic aortic dimension

  3 years

• Number of patients experiencing the listed peri-operative complications

  1 month

• Number of patients requiring open surgical or endovascular re-intervention

  3 years

Study Arms (2)

Hemiarch repair

ACTIVE COMPARATOR

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

Procedure: Hemiarch repair

Extended arch repair

ACTIVE COMPARATOR

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

Procedure: Extended arch repair

Interventions

Hemiarch repair PROCEDURE

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.

Hemiarch repair

Extended arch repair PROCEDURE

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.

Extended arch repair

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead

Study Sites (4)

London Health Sciences Centre

London, Ontario, N6A5A5, Canada

RECRUITING

University Health Network

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

Montreal Heart Institute

Montreal, Quebec, H1T 1C8, Canada

RECRUITING

Institut Universitaire De Cardiologie Et De Pneumologie de Québec

Québec, Quebec, G1V 4G5, Canada

RECRUITING

Related Publications (1)

• Elbatarny M, Stevens LM, Dagenais F, Peterson MD, Vervoort D, El-Hamamsy I, Moon M, Al-Atassi T, Chung J, Boodhwani M, Chu MWA, Ouzounian M; Canadian Thoracic Aortic Collaborative Investigators. Hemiarch versus extended arch repair for acute type A dissection: Results from a multicenter national registry. J Thorac Cardiovasc Surg. 2024 Mar;167(3):935-943.e5. doi: 10.1016/j.jtcvs.2023.04.012. Epub 2023 Apr 20.

  PMID: 37084820 DERIVED

MeSH Terms

Conditions

Aortic Dissection

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases

Study Officials

• Munir Boodhwani, MD

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

• Jehangir Appoo, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Khatira Mehdiyeva

CONTACT

613-696-7000; kmehdiyeva@ottawaheart.ca

Alice Black

CONTACT

403-389-8958; AlBlack@ottawaheart.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Hemiarch vs. extended arch repair in the setting of acute DeBakey type 1 aortic dissections

Study Record Dates

• First Submitted: March 16, 2019
• First Posted: March 21, 2019
• Study Start: July 30, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: September 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)