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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

HEADSTART Trial 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.Check my eligibility
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.See study design
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.

HEADSTART Trial 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.

HEADSTART Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of patients experiencing a composite end-point of mortality or re-intervention
Secondary outcome measures
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

HEADSTART 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
792 Previous Clinical Trials
868,972 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many healthcare centers are executing this experiment?

"Currently, this clinical trial is running in 4 distinct locations. These sites are based in Edmonton, London, and Calgary to name a few. To reduce travel requirements for potential participants of the study, it's recommended that they select the nearest site for their enrolment purposes."

Answered by AI

Who has the opportunity to take part in this experiment?

"This medical study requires 182 participants, aged between 18 and 70 years old, suffering from aortic dissection. In addition to meeting the age requirement, those who hope to be included must have their operating surgeon confirm that both surgeries would be safe and effective."

Answered by AI

Is this clinical experiment currently accepting participants?

"Affirmative. Clinicaltrials.gov has recorded that this particular medical trial is actively recruiting participants, having been posted on May 15th 2019 and recently updated on the same date. 182 patients are needed to be recruited from 4 different sites for completion of the study."

Answered by AI

Could you provide an estimate of the number of participants in this research endeavor?

"182 participants, who conform to the stipulated inclusion criteria, have been mandated to be involved in this medical research. Participants may originate from various sites such as Mazankowski Alberta Heart Institute in Edmonton and London Health Sciences Centre in London Ontario."

Answered by AI

Is the current recruitment process for this clinical trial limited to individuals aged 30 and above?

"This medical study is enrolling individuals aged 18 and above who are under the age of 70."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Hemiarch vs Extended Arch in Type 1 Aortic Dissection
Vamshi Kotha 2019. "Hemiarch vs Extended Arch in Type 1 Aortic Dissection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03885635.
~29 spots leftby Mar 2025
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