Hemiarch vs Extended Arch in Type 1 Aortic Dissection

Not Applicable

Recruiting

• Conditions: Aortic Dissection
• Interventions: Procedure: Hemiarch repair; Procedure: Extended arch repair

• Registration Number: NCT03885635
• Lead Sponsor: University of Calgary

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-03-16
• Study First Submitted QC: 2019-03-19
• Study First Posted: 2019-03-21
• Status Verified: 2019-05
• Study Start: 2019-05-15
• Last Update Submitted: 2019-05-15
• Last Update Posted: 2019-05-17
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 182

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hemiarch repair	Hemiarch repair	Standard hemiarch repair with open distal anastomosis in the proximal arch without replacement of the head vessels.
Extended arch repair	Extended arch repair	Ascending aortic and arch replacement with or without head vessel re-implantation and single TEVAR device placement within 1 week.

Primary Outcome Measures

Name	Time	Method
Number of patients experiencing a composite end-point of mortality or re-intervention	3 years	Compare the proportion of patients between the two groups who over a 3 year follow up period attain a composite clinical end-point of 1) mortality, 2) late aortic re-intervention, either surgical or endovascular (\> 30 days from index procedure) or 3) early (\< 30 days from index procedure) re-intervention for branch malperfusion

Secondary Outcome Measures

Name	Time	Method
Delta change in maximum cross-sectional descending thoracic aortic dimension	3 years	Compare delta change in the maximum cross-sectional descending thoracic dimension between the two groups over 3 years
Preoperative malperfusion and perioperative mortality/early re-intervention	1 month	Correlate pre-operative CT signs of malperfusion with peri-operative mortality and early post-operative re-intervention in both groups
Number of patients experiencing the listed peri-operative complications	1 month	To compare the proportion of patients experiencing the following peri-operative complications between the two groups: mortality, stroke, paraplegia/paraparesis, vascular injury, renal ischemia, bowel ischemia warranting operative intervention, peripheral limb ischemic changes and re-operation for bleeding.
Delta change in the ratio of true lumen to total aortic area (TL: Ao)	1 month	Compare delta change in the ratio of true lumen to total aortic area (TL:Ao) in the descending thoracic and abdominal aorta from pre-operative to first post-operative CT scans, between the two groups.
Number of patients achieving complete false lumen thrombosis on CT imaging	3 years	Compare the proportions of patients achieving complete false lumen (FL) thrombosis in the proximal, mid and distal descending thoracic aorta at 3 years after intervention between the two groups
Number of patients requiring open surgical or endovascular re-intervention	3 years	Compare the proportion of patients requiring open surgical and endovascular re-intervention over 3 years in both groups

Trial Locations

Locations (4)

University of Calgary; 🇨🇦 Calgary, Alberta, Canada

Mazankowski Alberta Heart Institute; 🇨🇦 Edmonton, Alberta, Canada

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada

New Brunswick Heart Centre; 🇨🇦 Saint John, New Brunswick, Canada