Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2025-12-25 @ 8:09 PM
Study NCT ID:
NCT03885635
Status:
RECRUITING
Last Update Posted:
2025-09-22
First Post:
2019-03-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hemiarch vs Extended Arch in Type 1 Aortic Dissection
Sponsor:
Ottawa Heart Institute Research Corporation
Organization:
Study Overview
Official Title:
Hemiarch vs Extended Arch in Aortic Dissection - a SystemaTic Analysis by Randomized Trial (HEADSTART)
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HEADSTART
Brief 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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: