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

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ClinicalTrials.gov Identifier: NCT03885635
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
Vamshi Kotha, University of Calgary

Study Description
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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.

Condition or disease Intervention/treatment Phase
Aortic Dissection Procedure: Hemiarch repair Procedure: Extended arch repair Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 182 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Hemiarch vs. extended arch repair in the setting of acute DeBakey type 1 aortic dissections
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hemiarch vs Extended Arch in Aortic Dissection - a SystemaTic Analysis by Randomized Trial (HEADSTART)
Estimated Study Start Date : May 15, 2019
Estimated Primary Completion Date : March 31, 2025
Estimated Study Completion Date : March 31, 2025
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Number of patients experiencing a composite end-point of mortality or re-intervention [ Time Frame: 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 :
  1. Number of patients achieving complete false lumen thrombosis on CT imaging [ Time Frame: 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

  2. Delta change in the ratio of true lumen to total aortic area (TL: Ao) [ Time Frame: 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.

  3. Delta change in maximum cross-sectional descending thoracic aortic dimension [ Time Frame: 3 years ]
    Compare delta change in the maximum cross-sectional descending thoracic dimension between the two groups over 3 years

  4. Number of patients experiencing the listed peri-operative complications [ Time Frame: 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.

  5. Number of patients requiring open surgical or endovascular re-intervention [ Time Frame: 3 years ]
    Compare the proportion of patients requiring open surgical and endovascular re-intervention over 3 years in both groups

  6. Preoperative malperfusion and perioperative mortality/early re-intervention [ Time Frame: 1 month ]
    Correlate pre-operative CT signs of malperfusion with peri-operative mortality and early post-operative re-intervention in both groups


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885635


Contacts
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Contact: Linet Kiplagat, MSc 403-220-3370 lkiplaga@ucalgary.ca
Contact: Vamshi Kotha, MD 403-389-8958 vamshi.kotha@ucalgary.ca

Locations
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Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada, T2N2T9
Contact: Vamshi Kotha, MD    4033898958    vamshi.kotha@ucalgary.ca   
Contact: Linet Kiplagat, MSc    4032203370    lkiplaga@ucalgary.ca   
Principal Investigator: Vamshi Kotha, MD         
Sub-Investigator: Jehangir Appoo, MD         
Sub-Investigator: Alex Gregory, MD         
Sub-Investigator: Eric Herget, MD         
Mazankowski Alberta Heart Institute Not yet recruiting
Edmonton, Alberta, Canada, T6G2B7
Contact: Jeff Cheng    7804076861    jeff.cheng@ualberta.ca   
Principal Investigator: Michael Moon, MD         
Canada, New Brunswick
New Brunswick Heart Centre Not yet recruiting
Saint John, New Brunswick, Canada, E2L4L2
Contact: Carole Dube    5066487360    Carole.Dube@horizonnb.ca   
Principal Investigator: Zlatko Pozeg, MD         
Canada, Ontario
London Health Sciences Centre Not yet recruiting
London, Ontario, Canada, N6A5A5
Contact: Stephen Mardell    5196858500 ext 34070    Stephen.Mardell@lhsc.on.ca   
Principal Investigator: Michael Chu, MD         
Sponsors and Collaborators
University of Calgary
Investigators
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Principal Investigator: Vamshi Kotha, MD University of Calgary
Principal Investigator: Jehangir Appoo, MD University of Calgary
More Information
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Responsible Party: Vamshi Kotha, Clinical Assistant Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT03885635    
Other Study ID Numbers: HEADSTART
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Aneurysm, Dissecting
Aneurysm
Vascular Diseases
Cardiovascular Diseases