Hemiarch vs Extended Arch in Type 1 Aortic Dissection

Aortic Dissection Clinical Trial

— HEADSTART  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03885635
• Other study ID #: HEADSTART
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2019
• Est. completion date: March 31, 2025

Study information

• Verified date: May 2019
• Source: University of Calgary
• Contact: Linet Kiplagat, MSc
• Phone: 403-220-3370
• Email: lkiplaga[@]ucalgary.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 182
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm, Dissecting
• Aortic Dissection

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	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

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients experiencing a composite end-point of mortality or re-intervention	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	3 years
Secondary	Number of patients achieving complete false lumen thrombosis on CT imaging	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	3 years
Secondary	Delta change in the ratio of true lumen to total aortic area (TL: Ao)	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.	1 month
Secondary	Delta change in maximum cross-sectional descending thoracic aortic dimension	Compare delta change in the maximum cross-sectional descending thoracic dimension between the two groups over 3 years	3 years
Secondary	Number of patients experiencing the listed peri-operative complications	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.	1 month
Secondary	Number of patients requiring open surgical or endovascular re-intervention	Compare the proportion of patients requiring open surgical and endovascular re-intervention over 3 years in both groups	3 years
Secondary	Preoperative malperfusion and perioperative mortality/early re-intervention	Correlate pre-operative CT signs of malperfusion with peri-operative mortality and early post-operative re-intervention in both groups	1 month