Hemiarch vs Extended Arch in Type 1 Aortic Dissection (HEADSTART)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Dissection
• Intervention / Treatment: Procedure: Hemiarch repair; Procedure: Extended arch repair

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.

• Study Type: Interventional
• Enrollment (Anticipated): 182
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Linet Kiplagat, MSc; Phone Number: 403-220-3370; Email: lkiplaga@ucalgary.ca
• Study Contact Backup: Name: Vamshi Kotha, MD; Phone Number: 403-389-8958; Email: vamshi.kotha@ucalgary.ca

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N2T9
      • Recruiting
      • University of Calgary
      • Contact: Vamshi Kotha, MD; Phone Number: 4033898958; Email: vamshi.kotha@ucalgary.ca
      • Contact: Linet Kiplagat, MSc; Phone Number: 4032203370; Email: lkiplaga@ucalgary.ca
      • Principal Investigator: Vamshi Kotha, MD
      • Sub-Investigator: Jehangir Appoo, MD
      • Sub-Investigator: Alex Gregory, MD
      • Sub-Investigator: Eric Herget, MD
    • Edmonton, Alberta, Canada, T6G2B7
      • Not yet recruiting
      • Mazankowski Alberta Heart Institute
      • Contact: Jeff Cheng; Phone Number: 7804076861; Email: jeff.cheng@ualberta.ca
      • Principal Investigator: Michael Moon, MD
  • New Brunswick
    • Saint John, New Brunswick, Canada, E2L4L2
      • Not yet recruiting
      • New Brunswick Heart Centre
      • Contact: Carole Dube; Phone Number: 5066487360; Email: Carole.Dube@horizonnb.ca
  • Ontario
    • London, Ontario, Canada, N6A5A5
      • Not yet recruiting
      • London Health Sciences Centre
      • Contact: Stephen Mardell; Phone Number: 34070 5196858500; Email: Stephen.Mardell@lhsc.on.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Calgary
• Investigators: Principal Investigator: Vamshi Kotha, MD, University of Calgary

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 15, 2019
• Primary Completion (ANTICIPATED): March 31, 2025
• Study Completion (ANTICIPATED): March 31, 2025

Study Registration Dates

• First Submitted: March 16, 2019
• First Submitted That Met QC Criteria: March 19, 2019
• First Posted (ACTUAL): March 21, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 17, 2019
• Last Update Submitted That Met QC Criteria: May 15, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Aneurysm, Dissecting
• Other Study ID Numbers: HEADSTART

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No