Aortic DissectionHEADSTARTNCT03885635
Hemiarch vs Extended Arch in Type 1 Aortic Dissection
A study testing Hemiarch repair and Extended arch repair in people with Aortic Dissection, run by Ottawa Heart Institute Research Corporation at 5 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Aortic Dissection
- What is being tested?
- Hemiarch repair and Extended arch repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 5 sitesCanada
- Study dates
- 30 Jul 2024to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 9Show fewer
- History of chronic renal failure (baseline eGFR < 50)
- Metastatic malignancy
- Pregnancy
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Canada5 sites, 5 recruiting
- Recruiting
London Health Sciences Centre
London, Ontario, N6A5A5
Stephen Mardell, 5196858500 ext. 34070, Stephen.Mardell@lhsc.on.ca
Michael Chu, MD
- Recruiting
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
Asma Hamlili, 514-376-3330 ext. 3725, asma.hamlili@icm-mhi.org
Alexandre Bergeron, 514-376-3330 ext. 3725, alexandre.bergeron.icm@icm-mhi.org
- Recruiting
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
Khatira Mehdiyeva, 613-696-7000, kmehdiyeva@ottawaheart.ca
Munir Boodhwani, MD
- Recruiting
Institut Universitaire De Cardiologie Et De Pneumologie de Québec
Québec, Quebec, G1V 4G5
Annie Bergeron, 418-656-8711 ext. 2768, annie.bergeron@criucpq.ulaval.ca
François Dagenais, MD
- Recruiting
University Health Network
Toronto, Ontario, M5G 2C4
Waleed Alnimr, 416 340 4800, Waleed.AlNimr@uhn.ca
Maral Ouzounian, MD
About this study
Official title: Hemiarch vs Extended Arch in Aortic Dissection - a SystemaTic Analysis by Randomized Trial (HEADSTART)
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.
Read the detailed description
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.
- Conditions
- Aortic Dissection
- Being tested
- Hemiarch repair, Extended arch repair
- Medical subject headings
- Aortic Dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemiarch repairProcedure or surgery
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 repairProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| Hemiarch repair | Active comparator | Standard hemiarch repair with open distal anastomosis in the proximal arch without replacement of the head vessels. Receives: 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. Receives: Procedure: Extended arch repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years
Secondary outcomes (6)
Number of patients achieving complete false lumen thrombosis on CT imaging
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
Measured: 3 years
Delta change in the ratio of true lumen to total aortic area (TL: Ao)
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.
Measured: 1 month
Delta change in maximum cross-sectional descending thoracic aortic dimension
Compare delta change in the maximum cross-sectional descending thoracic dimension between the two groups over 3 years
Measured: 3 years
Number of patients experiencing the listed peri-operative complications
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.
Measured: 1 month
Number of patients requiring open surgical or endovascular re-intervention
Compare the proportion of patients requiring open surgical and endovascular re-intervention over 3 years in both groups
Measured: 3 years
Preoperative malperfusion and perioperative mortality/early re-intervention
Correlate pre-operative CT signs of malperfusion with peri-operative mortality and early post-operative re-intervention in both groups
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start30 Jul 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic DissectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Hemiarch vs. extended arch repair in the setting of acute DeBakey type 1 aortic dissections
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Munir Boodhwani, MD, Principal investigator, Ottawa Heart Institute Research CorporationJehangir Appoo, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03885635
- Sponsor's protocol ID
- HEADSTART
- Acronym
- HEADSTART
- Status last verified
- Sep 2026
- First submitted
- 16 Mar 2019
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37084820
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemiarch vs Extended Arch in Aortic Dissection - a SystemaTic Analysis by Randomized Trial (HEADSTART)
- ClinicalTrials.gov ID
- NCT03885635
- Acronym / sponsor ID
- HEADSTART / HEADSTART
- Conditions
- Aortic Dissection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 21 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Hemiarch vs. extended arch repair in the setting of acute DeBakey type 1 aortic dissections
| Arm | Type | Receives |
|---|---|---|
| Hemiarch repair | Active comparator | Procedure: Hemiarch repairStandard hemiarch repair with open distal anastomosis in the proximal arch without replacement of the head vessels. |
| Extended arch repair | Active comparator | Procedure: Extended arch repairAscending aortic and arch replacement with or without head vessel re-implantation and single TEVAR device placement within 1 week. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hemiarch repairCurrent 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. | Procedure or surgery | Hemiarch repair |
| Extended arch repairSurgical 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. | Procedure or surgery | Extended arch repair |
Primary outcome
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
6 secondary outcomes
Number of patients achieving complete false lumen thrombosis on CT imaging
Time frame: 3 years
Delta change in the ratio of true lumen to total aortic area (TL: Ao)
Time frame: 1 month
Delta change in maximum cross-sectional descending thoracic aortic dimension
Time frame: 3 years
Number of patients experiencing the listed peri-operative complications
Time frame: 1 month
Number of patients requiring open surgical or endovascular re-intervention
Time frame: 3 years
Preoperative malperfusion and perioperative mortality/early re-intervention
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Derived from this study: PubMed 37084820Elbatarny 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Munir Boodhwani, MD principal investigator
Ottawa Heart Institute Research Corporation
Jehangir Appoo, MD principal investigator
University of Calgary
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemiarch repair and Extended arch repair in people with Aortic Dissection, run by Ottawa Heart Institute Research Corporation at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Khatira Mehdiyeva (613-696-7000 ext. 18328, kmehdiyeva@ottawaheart.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients experiencing a composite end-point of mortality or re-intervention (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03885635, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.