Comparing TEVAR with Guideline directed medical therapy and for type b aortic dissection
Official title: IMPRoving Outcomes in Vascular DisEase - Aortic Dissection
IMPRoving Outcomes in Vascular DisEase- Aortic Dissection
- 2 groups
- 2 sites in Montreal
- Recruiting
Interventions
- Medical procedure
TEVAR
Thoracic endovascular aortic repair
- Other intervention
Guideline directed medical therapy and surveillance of dissection
Routine clinical care with suggested antihypertensive therapy and cardiovascular risk factor reduction as per appropriate cardiovascular guidelines.
Canadian Sites (2)
2 of 2 recruiting
- Recruiting
CHUM - Centre hospitalier de l'Universite de Montreal
Montreal, Quebec
- Recruiting
McGill University Medical Center
Montreal, Quebec
Eligibility Criteria
See who this study is looking for12 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Age \> 21 years
- +Patients with a Stanford type B aortic dissection not involving the aorta at or proximal to the innominate artery, without rupture and/or malperfusion syndrome (renal, mesenteric, or extremity) who are within 48 hours to 6 weeks after start of index admission for their type B dissection
- +Ability to provide written informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →
- +InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → believes anatomy is suitable for TEVAR
Exclusion
- −Ongoing systemic infection
- −Life expectancy related to non-aortic conditions \< 2 years
- −Unwilling or unable to comply with all study procedures
- −Known patient history of genetic aortopathy
- −Penetrating Aortic Ulcer without concomitant uTBAD
- −Intramural hematoma without concomitant uTBAD
- −Iatrogenic (traumatic) aortic dissection
- −Pregnant or planning to become pregnant in the next 3 months
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives TEVAR, together with one or more of: Guideline directed medical therapy and surveillance of dissection.
Registry label: A: Upfront TEVAR plus Medical Therapy
Group B, the comparison group, receives Guideline directed medical therapy and surveillance of dissection.
Registry label: B: Medical Therapy with surveillance for deterioration
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
One group of people involved — usually the participants — is not told which treatment is which.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 21 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 1,100 people.
The study is currently expected to finish around June 2030.
The main measurement is taken over: Last follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → timepoint. Differential follow-up with median of about 4 years.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
All-cause death or major aortic complications (MAC) — measured over Last follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → timepoint. Differential follow-up with median of about 4 years.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06087029 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About TEVARProcedure
Thoracic endovascular aortic repair
From the trial registry — its own words, unedited.
What a procedure is here: A surgery, technique or clinical procedure being studied.
Read the full explanation → · in clinical review
About Guideline directed medical therapy and surveillance of dissectionOther
Routine clinical care with suggested antihypertensive therapy and cardiovascular risk factor reduction as per appropriate cardiovascular guidelines.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 21 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
One group of people involved — usually the participants — is not told which treatment is which.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 21 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Last follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → timepoint. Differential follow-up with median of about 4 years.
The study as a whole is currently expected to finish around 2030-06-30.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 1,100 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 13 locations, including: Montreal, Quebec, Canada; Ann Arbor, Michigan, United States; Detroit, Michigan, United States; Grand Rapids, Michigan, United States; Minneapolis, Minnesota, United States; Rochester, Minnesota, United States, and 7 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
The goal of this clinical trial is to determine whether an upfront invasive strategy of TEVAR plus medical therapy reduces the occurrence of a composite endpoint of all-cause death or major aortic complications compared to an upfront conservative strategy of medical therapy with surveillance for deterioration in patients with uncomplicated type B aortic dissection.
Other Sites (13)
University of Michigan Health
Ann Arbor, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Spectrum Health and Hospitals and Corewell
Grand Rapids, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Maimonides Medical Center
Brooklyn, New York, United States
NYU Langone Health
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
St. Francis Hospital and Heart Center
Roslyn, New York, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
SUNY Upstate Medical University
Syracuse, New York, United States
University of Washington
Seattle, Washington, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.