Clinical trial NCT03885635: Hemiarch vs Extended Arch in Type 1 Aortic Dissection
Official title: Hemiarch vs Extended Arch in Aortic Dissection - a SystemaTic Analysis by Randomized Trial (HEADSTART)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aortic Dissection
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2019-03-21
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Hemiarch vs. extended arch repair in the setting of acute DeBakey type 1 aortic dissections
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria

1. Emergent surgical repair of Acute DeBakey Type 1 aortic dissection
2. Age \>18 years and \<70 years
3. Operating surgeon believes that both surgeries could be safe and effective

Exclusion Criteria

1. Hemodynamic instability/shock defined as systolic BP \< 90 mm Hg
2. Previous cardiac surgery with sternotomy or thoracic endograft placement
3. Aortic arch diameter \> 6cm in which a concomitant arch replacement is judged necessary
4. Procedures deemed to be "salvage operations" where the patient is unlikely to survive hospital discharge.
5. GCS \< 8 for more than 6 hours
6. History of cirrhosis.
7. History of chronic renal failure (baseline eGFR \< 50)
8. Metastatic malignancy
9. Pregnancy

Primary outcomes:
measure: Number of patients experiencing a composite end-point of mortality or re-intervention
timeFrame: 3 years
Secondary outcomes:
measure: Number of patients achieving complete false lumen thrombosis on CT imaging
timeFrame: 3 years
measure: Delta change in the ratio of true lumen to total aortic area (TL: Ao)
timeFrame: 1 month
measure: Delta change in maximum cross-sectional descending thoracic aortic dimension
timeFrame: 3 years
measure: Number of patients experiencing the listed peri-operative complications
timeFrame: 1 month
measure: Number of patients requiring open surgical or endovascular re-intervention
timeFrame: 3 years
measure: Preoperative malperfusion and perioperative mortality/early re-intervention
timeFrame: 1 month
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: Mazankowski Alberta Heart Institute
state: Alberta
city: Saint John
country: Canada
facility: New Brunswick Heart Centre
state: New Brunswick
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: University of Calgary
name: Vamshi Kotha, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Calgary
name: Jehangir Appoo, MD
role: PRINCIPAL_INVESTIGATOR
References: