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Procedure

Hemiarch vs Extended Arch Surgery for Aortic Dissection (HEADSTART Trial)

N/A
Recruiting
Led By Vamshi Kotha, MD
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age >18 years and <70 years
Emergent surgical repair of Acute DeBakey Type 1 aortic dissection
Must not have
Procedures deemed to be "salvage operations" where the patient is unlikely to survive hospital discharge
History of chronic renal failure (baseline eGFR < 50)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is comparing two different surgical strategies for people with a specific kind of aortic dissection. One group will have a hemiarch repair and the other group will have an extended arch repair. Clinical and imaging data will be collected over 3 years to see which strategy is better.

Who is the study for?
This trial is for adults aged 18-70 with acute DeBakey Type 1 aortic dissection, where surgeons believe both hemiarch and extended arch repairs could work. It's not for those with cirrhosis, pregnant women, people in shock (very low blood pressure), prior major heart surgeries or thoracic endografts, patients unlikely to survive after surgery, severe brain injury (low GCS for over 6 hours), very large aortic arches needing replacement (>6cm), metastatic cancer, or chronic kidney failure.
What is being tested?
The HEADSTART trial compares two surgical methods—hemiarch repair and extended arch repair—for treating acute DeBakey type 1 aortic dissection. Patients will be randomly assigned to one of the procedures and monitored for outcomes like survival and need for additional interventions over three years.
What are the potential side effects?
While specific side effects are not listed here, surgeries on the aorta can include risks such as bleeding, infection at the incision site, stroke due to disrupted blood flow during operation, damage to organs if blood supply is affected temporarily during surgery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 70 years old.
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I need urgent surgery for a major artery rupture.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not expected to survive after my current hospital treatment.
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I have chronic kidney disease with an eGFR below 50.
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My aortic arch is larger than 6cm and needs surgery.
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I have had heart or chest surgery involving cutting through the breastbone or placing a stent in the chest.
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My consciousness level has been very low for over 6 hours.
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I have a history of cirrhosis.
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My cancer has spread to other parts of my body.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of patients experiencing a composite end-point of mortality or re-intervention
Secondary study objectives
Delta change in maximum cross-sectional descending thoracic aortic dimension
Delta change in the ratio of true lumen to total aortic area (TL: Ao)
Number of patients achieving complete false lumen thrombosis on CT imaging
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Hemiarch repairActive Control1 Intervention
Standard hemiarch repair with open distal anastomosis in the proximal arch without replacement of the head vessels.
Group II: Extended arch repairActive Control1 Intervention
Ascending aortic and arch replacement with or without head vessel re-implantation and single TEVAR device placement within 1 week.

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor
809 Previous Clinical Trials
886,632 Total Patients Enrolled
Vamshi Kotha, MDPrincipal InvestigatorUniversity of Calgary
Jehangir Appoo, MDPrincipal InvestigatorUniversity of Calgary
1 Previous Clinical Trials
610 Total Patients Enrolled

Media Library

Extended arch repair (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03885635 — N/A
Aortic Dissection Research Study Groups: Hemiarch repair, Extended arch repair
Aortic Dissection Clinical Trial 2023: Extended arch repair Highlights & Side Effects. Trial Name: NCT03885635 — N/A
Extended arch repair (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03885635 — N/A
~10 spots leftby Mar 2025
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