Endovascular Abdominal Aortic Aneurysm Repair (EVAR)EVARNCT01452620
Endovascular Abdominal Aortic Aneurysm Repair by Interventional Cardiologists
An observational study of Endovascular Abdominal Aortic Aneurysm Repair (EVAR), run by St. Joseph Mercy Oakland Hospital at 1 site in United States.
Trial summary
Registry for Endovascular repair of abdominal aortic aneurysm performed primarily by Interventional Cardiologists Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endovascular Abdominal Aortic Aneurysm Repair (EVAR)
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to May 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study patients comprised of all patients undergoing endovascular abdominal aortic aneurysm repair performed primarily by Interventional Cardiologists in our community setting.
Who may be able to join
- Patients with abdominal aortic aneurysm amenable for endovascular repair
Who cannot join
- Pregnant patients
- Patients less than 18 years old.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Joseph Mercy Oakland Hospital
Pontiac, Michigan, 48341
About this study
Registry for Endovascular repair of abdominal aortic aneurysm performed primarily by Interventional Cardiologists
- Keywords
- Endovascular Abdominal Aortic Aneurysm Repair (EVAR), Abdominal Aortic aneurysm (AAA)
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| EVAR cohort | All consecutive patients undergoing endovascular AAA repair (EVAR) in our community setting were followed for outcomes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: mean follow up, 30 months
Secondary outcomes (1)
Complications
Peri-procedural (30 day) and follow up complications
Measured: mean follow up, 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2011 (estimated)
- Study startJan 2011
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endovascular Abdominal Aortic Aneurysm Repair (EVAR)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph Mercy Oakland Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abhijeet Basoor, St. Joseph Mercy Oakland Hospital
- Investigators
- Abhijeet Basoor, MD, Principal investigator, St. Joseph Mercy Oakland HospitalKiritkumar Patel, MD, Study director, St. Joseph Mercy Oakland HospitalAbdul R Halabi, MD, Study director, St. Joseph Mercy Oakland HospitalNishit Choksi, MD, Study director, St. Joseph Mercy Oakland HospitalThanh Phan, MD, Study director, St. Joseph Mercy Oakland HospitalMichele DeGregorio, MD, Study director, St. Joseph Mercy Oakland Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01452620
- Sponsor's protocol ID
- 11-10-01
- Acronym
- EVAR
- Status last verified
- Oct 2011
- First submitted
- 12 Oct 2011
- Last updated
- 17 Oct 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endovascular Abdominal Aortic Aneurysm Repair by Interventional Cardiologists
- ClinicalTrials.gov ID
- NCT01452620
- Acronym / sponsor ID
- EVAR / 11-10-01
- Keywords
- Endovascular Abdominal Aortic Aneurysm Repair (EVAR), Abdominal Aortic aneurysm (AAA)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- St. Joseph Mercy Oakland HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 17 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Registry for Endovascular repair of abdominal aortic aneurysm performed primarily by Interventional Cardiologists
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EVAR cohort | – | –All consecutive patients undergoing endovascular AAA repair (EVAR) in our community setting were followed for outcomes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study patients comprised of all patients undergoing endovascular abdominal aortic aneurysm repair performed primarily by Interventional Cardiologists in our community setting.
Key inclusion criteria (1 listed)
- Patients with abdominal aortic aneurysm amenable for endovascular repair
Key exclusion criteria (2 listed)
- Pregnant patients
- Patients less than 18 years old.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: mean follow up, 30 months
1 secondary outcome
Complications
Time frame: mean follow up, 30 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abhijeet Basoor, MD principal investigator
St. Joseph Mercy Oakland Hospital
Kiritkumar Patel, MD study director
St. Joseph Mercy Oakland Hospital
Abdul R Halabi, MD study director
St. Joseph Mercy Oakland Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endovascular Abdominal Aortic Aneurysm Repair (EVAR), run by St. Joseph Mercy Oakland Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: mean follow up, 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2011.