Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
ID03885635

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

Led by Ottawa Heart Institute Research Corporation · Updated on 2025-09-22

50

Participants Needed

4

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating two surgical methods, hemiarch repair and extended arch repair, for patients with acute DeBakey Type 1 aortic dissection, a serious heart condition. This prospective, randomized trial aims to compare patient outcomes, including mortality and the need for additional surgeries, over a three-year follow-up period. The study addresses uncertainty about the best surgical approach and patient selection to improve long-term results and reduce complications. Participants will be randomly assigned to receive either the standard hemiarch repair, which involves replacing the ascending aorta without treating the mid arch or descending aorta, or the extended arch repair, which includes more extensive replacement of the aorta and arch with or without re-implantation of head vessels and a stent graft device. Both procedures follow each participating center's standard practices for anesthesia and brain protection. Clinical and CT imaging data will be collected before surgery, shortly after, and during long-term follow-up. During the study, participants will undergo clinical evaluations and imaging scans to monitor outcomes such as survival, complications, and changes in aortic structure for up to three years. Researchers will track the occurrence of mortality, need for re-intervention, and aortic healing measures like false lumen thrombosis and aortic size changes. This comprehensive data collection aims to clarify which surgical technique offers better patient outcomes over time.

CONDITIONS

Brief Title

Hemiarch vs Extended Arch in Type 1 Aortic Dissection

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Emergent surgical repair of Acute DeBakey Type 1 aortic dissection
  • Age over 18 years and under 70 years
  • Operating surgeon believes that both surgeries could be safe and effective
Not Eligible

You will not qualify if you...

  • Hemodynamic instability or shock with systolic blood pressure below 90 mm Hg
  • Previous cardiac surgery with sternotomy or thoracic endograft placement
  • Aortic arch diameter over 6 cm requiring arch replacement
  • Salvage operations where survival to hospital discharge is unlikely
  • Glasgow Coma Scale less than 8 for more than 6 hours
  • History of cirrhosis
  • History of chronic renal failure with baseline eGFR under 50
  • Metastatic cancer
  • Pregnancy

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

screening and enrollment visit

Surgery and Immediate Post-operative Care

Duration - Up to 1 week

Participants undergo either hemiarch or extended arch surgical repair for acute DeBakey Type 1 aortic dissection. Post-operative management occurs during hospitalization.

1 surgical hospitalization

Post-operative Follow-up

Duration - Up to 3 years

Participants are followed with clinical assessments and CT imaging to monitor recovery and aortic remodeling.

Multiple follow-up visits including assessments at 1 month and periodic visits up to 3 years

Trial Site Locations

Total: 4 locations

1

London Health Sciences Centre

London, Ontario, Canada, N6A5A5

Actively Recruiting

2

University Health Network

Toronto, Ontario, Canada, M5G 2C4

Actively Recruiting

3

Montreal Heart Institute

Montreal, Quebec, Canada, H1T 1C8

Actively Recruiting

4

Institut Universitaire De Cardiologie Et De Pneumologie de Québec

Québec, Quebec, Canada, G1V 4G5

Actively Recruiting

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Research Team

K

Khatira Mehdiyeva

A

Alice Black

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Hemiarch versus extended arch repair for acute type A dissection: Results from a multicenter national registry.

Malak Elbatarny, Louis-Mathieu Stevens, Francois Dagenais...

https://pubmed.ncbi.nlm.nih.gov/37084820