Hemiarch vs Extended Arch in Type 1 Aortic Dissection
ConditionAortic Dissection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorOttawa Heart Institute Research Corporation
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Hemiarch repair
- Extended arch repair
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov