Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03885635

Hemiarch vs Extended Arch in Type 1 Aortic Dissection

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

London Health Sciences Centre, London, Ontario, Canada

Loading trial locations.

About this study

DeBakey Type 1 aortic dissections continue to have high operative mortality and morbidity and there is equipoise in available literature with regards to the best operative strategy and patient selection criteria. Hemiarch repair is current standard of care in most centers but extended arch repair is gaining popularity aiming to address early post-operative malperfusion and improve long term aortic remodeling.

HEADSTART is a randomized controlled prospective trial of patients presenting to participating institutes with acute DeBakey 1 aortic dissection. Patients will be enrolled and randomized into one of two groups - 'hemiarch repair' and 'extended arch repair'. Pre-operative, early post-operative and long term follow clinical and CT imaging data will be collated on a centralized database and at a core lab respectively.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: 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

Secondary outcomes

  1. Number of patients achieving complete false lumen thrombosis on CT imaging

    Time frame: 3 years

    Compare the proportions of patients achieving complete false lumen (FL) thrombosis in the proximal, mid and distal descending thoracic aorta at 3 years after intervention between the two groups

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

    Time frame: 1 month

    Compare delta change in the ratio of true lumen to total aortic area (TL:Ao) in the descending thoracic and abdominal aorta from pre-operative to first post-operative CT scans, between the two groups.

  3. Delta change in maximum cross-sectional descending thoracic aortic dimension

    Time frame: 3 years

    Compare delta change in the maximum cross-sectional descending thoracic dimension between the two groups over 3 years

  4. Number of patients experiencing the listed peri-operative complications

    Time frame: 1 month

    To compare the proportion of patients experiencing the following peri-operative complications between the two groups: mortality, stroke, paraplegia/paraparesis, vascular injury, renal ischemia, bowel ischemia warranting operative intervention, peripheral limb ischemic changes and re-operation for bleeding.

  5. Number of patients requiring open surgical or endovascular re-intervention

    Time frame: 3 years

    Compare the proportion of patients requiring open surgical and endovascular re-intervention over 3 years in both groups

  6. Preoperative malperfusion and perioperative mortality/early re-intervention

    Time frame: 1 month

    Correlate pre-operative CT signs of malperfusion with peri-operative mortality and early post-operative re-intervention in both groups

Study contacts

Contact information is provided by the study sponsor or research team.

Alice Black

CONTACT

[email protected]

403-389-8958 ext. 613-696-7230

Khatira Mehdiyeva

CONTACT

[email protected]

613-696-7000 ext. 18328

Sponsors and collaborators

Lead sponsor

Ottawa Heart Institute Research Corporation

Other

Registry information

Official study title

Hemiarch vs Extended Arch in Aortic Dissection - a SystemaTic Analysis by Randomized Trial (HEADSTART)

Acronym: HEADSTART

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 21, 2019
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.