NCT03885635

Hemiarch vs Extended Arch in Type 1 Aortic Dissection

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Ottawa Heart Institute Research Corporation · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Aortic Dissection

Interventions

Type	Name	Description
PROCEDURE	Hemiarch repair	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.
PROCEDURE	Extended arch repair	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.

Timeline

• Start date: 2024-07-30
• Primary completion: 2027-03-31
• Completion: 2027-03-31
• First posted: 2019-03-21
• Last updated: 2025-09-22

Locations

4 sites across 1 country: Canada