Hemiarch vs Extended Arch in Type 1 Aortic Dissection (HEADSTART)
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- STATUS
- Recruiting
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- End date
- Mar 31, 2025
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- participants needed
- 182
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- sponsor
- University of Calgary
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.
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.
Details
| Condition | Aortic Dissection |
|---|---|
| Treatment | Hemiarch repair, Extended arch repair |
| Clinical Study Identifier | NCT03885635 |
| Sponsor | University of Calgary |
| Last Modified on | 7 February 2022 |
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