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Hemiarch vs Extended Arch in Type 1 Aortic Dissection

ConditionAortic Dissection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorOttawa Heart Institute Research Corporation

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Emergent surgical repair of Acute DeBakey Type 1 aortic dissection

Age >18 years and <70 years

Operating surgeon believes that both surgeries could be safe and effective

Disqualifiers

Hemodynamic instability/shock defined as systolic BP < 90 mm Hg

Previous cardiac surgery with sternotomy or thoracic endograft placement

Aortic arch diameter > 6cm in which a concomitant arch replacement is judged necessary

Procedures deemed to be "salvage operations" where the patient is unlikely to survive hospital discharge.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hemiarch repair

    Procedure/Surgery

    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.

  • Extended arch repair

    Procedure/Surgery

    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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Hemiarch repairActive comparator 1 intervention
Group B: Extended arch repairActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
3 years

Secondary outcomes

1

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

Time frame
3 years
2

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.

Time frame
1 month
3

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

Time frame
3 years
4

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.

Time frame
1 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ottawa Heart Institute Research Corporation

Lead sponsor

Source ClinicalTrials.gov
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