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
|Condition or disease||Intervention/treatment||Phase|
|Aortic Dissection||Procedure: Hemiarch repair Procedure: Extended arch repair||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||182 participants|
|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)|
|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|
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.
- 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
- 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
- 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.
- 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
- 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.
- 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
- 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
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
|Contact: Linet Kiplagat, MScfirstname.lastname@example.org|
|Contact: Vamshi Kotha, MDemail@example.com|
|University of Calgary||Recruiting|
|Calgary, Alberta, Canada, T2N2T9|
|Contact: Vamshi Kotha, MD 4033898958 firstname.lastname@example.org|
|Contact: Linet Kiplagat, MSc 4032203370 email@example.com|
|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 firstname.lastname@example.org|
|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|
|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|
|Principal Investigator:||Vamshi Kotha, MD||University of Calgary|
|Principal Investigator:||Jehangir Appoo, MD||University of Calgary|