ABDOMINAL AORTIC ANEURYSMSNCT00444821
The (PIVOTAL) Study
A study testing AneuRx AAA stent graft / Talent AAA stent graft in people with ABDOMINAL AORTIC ANEURYSMS, run by Medtronic Cardiovascular at 65 sites in United States.
Trial summary
The purpose of this study is to compare endovascular repair using any FDA approved Medtronic AAA Stent Graft System versus surveillance in subjects with smaller abdominal aortic aneurysms (AAA)(4-5CM), with respect to AAA rupture and AAA related deaths. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- ABDOMINAL AORTIC ANEURYSMS
- What is being tested?
- AneuRx AAA stent graft / Talent AAA stent graft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 728 participants
- Where
- 65 sitesUnited States
- Study dates
- Mar 2005to Jan 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 40 to 90 years of age
- Meet all indications for use as stated in the Medtronic Vascular AAA Endograft Instructions for Use
- Maximum aneurysm diameter of 4-5cm
- If female patient with child bearing potential, must have a documented negative pregnancy test within seven(7)days prior to inclusion
- Patient is willing and able to comply with the specified follow-up evaluation
- Life expectancy at least 3 years
Who cannot join
- Meet any of the Contraindications stated in the Medtronic Vascular AAA Endograft instructions for Use
- Known co-existing condition with a life expectancy of less than 3 years
- Major surgical or interventional procedure (vascular and/or non-vascular)within 30 days prior to study enrollment
- Subjects enrolled in another clinical trial or anticipated to be included into a trial, which may interfere with this study, or subjects already enrolled in this trial before.
- Planned conduit procedure for introduction of endograft
Trial locations and contacts
65 sites in 1 country.
65 sites in 1 country
United States65 sites
Albany Medical Center
Albany, New York
Lehigh Valley Hospital
Allentown, Pennsylvania
University of Michigan
Ann Arbor, Michigan
Mission / St. Joseph Hospital
Asheville, North Carolina
Tri-State Vascular Group
Ashland, Kentucky
St. Joseph's Research Institute
Atlanta, Georgia
Vascular Surgery Associates
Baton Rouge, Louisiana
Vascular Surgery Associates
Bel Air, Maryland
University of Alabama
Birmingham, Alabama
Brigham and Women's Hospital
Boston, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts
University of North Carolina
Chapel Hill, North Carolina
Presbyterian Hospital
Charlotte, North Carolina
University of Virginia
Charlottesville, Virginia
University Surgical Associates
Chattanooga, Tennessee
University of Chicago
Chicago, Illinois
The Lindner Clinical Trials Center
Cincinnati, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio
Ohio State University
Columbus, Ohio
Methodist Dallas Medical Center
Dallas, Texas
UT Southwestern Medical Center
Dallas, Texas
The Dayton Heart Center
Dayton, Ohio
Decatur Memorial Hospital
Decatur, Illinois
Iowa Heart Center
Des Moines, Iowa
Palomar Hospital
Escondido, California
Michigan Vascular Center
Flint, Michigan
University of Florida
Gainesville, Florida
East Carolina University
Greenville, North Carolina
Westchester Medical Center
Hawthorne, New York
Adventist Midwest Health
Hinsdale, Illinois
Baylor College of Medicine
Houston, Texas
Mayo Clinic
Jacksonville, Florida
St. John's Regional Medical Center
Joplin, Missouri
Wilford Hall Medical Center
Lackland Air Force Base, Texas
South Central Regional Medical Center
Laurel, Mississippi
Leesburg Regional Medical Center
Leesburg, Florida
VA Hospital
Little Rock, Arkansas
Long Beach VA Healthcare System
Long Beach, California
UCLA Medical Center
Los Angeles, California
University of Southern California
Los Angeles, California
Wisconsin Heart / Meriter Hospital
Madison, Wisconsin
Wellstar Clinical Trials
Marietta, Georgia
Oregon
Medford, Oregon
Baptist Memorial Hospital
Memphis, Tennessee
Cardiac Surgery Associates
Munster, Indiana
St. Thomas Hospital
Nashville, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee
Columbia University Medical Center
New York, New York
Sentara Heart Hospital
Norfolk, Virginia
Stanford University VA
Palo Alto, California
UPMC Vascular Surgery
Pittsburgh, Pennsylvania
Mayo Clinic
Rochester, Minnesota
William Beaumont Hospital
Royal Oak, Michigan
UC Davis Medical Center
Sacramento, California
North Central Heart Institute
Sioux Falls, South Dakota
Sacred Heart Medical Center
Spokane, Washington
Southern Illinois University
Springfield, Illinois
Stanford University Medical Center
Stanford, California
Staten Island University Hospital
Staten Island, New York
University of South Florida
Tampa, Florida
Texas
Temple, Texas
Jobst Vascular Center
Toledo, Ohio
Tucson Vascular Surgery
Tucson, Arizona
University of Arizona - UMC
Tucson, Arizona
Wake Forest University School of Medicine
Winston-Salem, North Carolina
About this study
Official title: Positive Impact of Endovascular Options for Treating Aneurysms Early (PIVOTAL)
The purpose of this study is to compare endovascular repair using any FDA approved Medtronic AAA Stent Graft System versus surveillance in subjects with smaller abdominal aortic aneurysms (AAA)(4-5CM), with respect to AAA rupture and AAA related deaths.
- Conditions
- ABDOMINAL AORTIC ANEURYSMS
- Being tested
- AneuRx AAA stent graft / Talent AAA stent graft
- Keywords
- AAA, Aneurysm, AneuRx, Talent
- Medical subject headings
- Aortic Aneurysm, Abdominal, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AneuRx AAA stent graft / Talent AAA stent graftDevice
Catheter based stent graft inserted to seal off an abdominal aortic aneurysm
| Study group | Role | What they receive |
|---|---|---|
| Surveillance | No intervention | Not described |
| Early Endovascular Repair | Experimental | Not described Receives: Device: AneuRx AAA stent graft / Talent AAA stent graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects That Experienced Rupture or Aneurysm Related Death
Measured: 3 years
Secondary outcomes (2)
Aneurysm Growth >0.5 cm
After repair, AAA enlargement by >0.5cm
Measured: 1 year
Secondary Endovascular Procedures Between the 30-day Post Treatment and 3-year Follow-up
secondary interventions in those that had successful delivery and deployment by treatment group randomized to.
Measured: study termination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2007 (estimated)
- Study startMar 2005
- Primary completionJan 2010
- Study completionJan 2010
Why it stopped: Interim analysis of Primary Endpoint completed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ABDOMINAL AORTIC ANEURYSMSStudies of the same condition, open and under way.
- More trials run by Medtronic CardiovascularThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 728 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiovascular
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Cleveland Clinic
- Responsible party
- Sponsor
- Investigators
- Kenneth Ouriel, MD, Principal investigator, New York Presbyterian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00444821
- Sponsor's protocol ID
- VS-2005-01
- Status last verified
- Oct 2021
- First submitted
- 6 Mar 2007
- Last updated
- 11 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Eisenstein EL, Davidson-Ray L, Edwards R, Anstrom KJ, Ouriel K. Economic analysis of endovascular repair versus surveillance for patients with small abdominal aortic aneurysms. J Vasc Surg. 2013 Aug;58(2):302-10. doi: 10.1016/j.jvs.2013.01.038. Epub 2013 Apr 4.
PubMed 23562339
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positive Impact of Endovascular Options for Treating Aneurysms Early (PIVOTAL)
- ClinicalTrials.gov ID
- NCT00444821
- Acronym / sponsor ID
- VS-2005-01
- Conditions
- ABDOMINAL AORTIC ANEURYSMS
- Keywords
- AAA, Aneurysm, AneuRx, Talent
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis of Primary Endpoint completed
- Enrolment
- 728 participants (actual)
- Lead sponsor
- Medtronic CardiovascularIndustry (pharma, biotech, devices)
- Collaborators
- The Cleveland Clinic
- Study start
- Mar 2005
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 8 Mar 2007 (estimated)
- Results
- Posted 23 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare endovascular repair using any FDA approved Medtronic AAA Stent Graft System versus surveillance in subjects with smaller abdominal aortic aneurysms (AAA)(4-5CM), with respect to AAA rupture and AAA related deaths.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surveillance | No intervention | – |
| Early Endovascular Repair | Experimental | Device: AneuRx AAA stent graft / Talent AAA stent graft |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 40 to 90 years of age
- Meet all indications for use as stated in the Medtronic Vascular AAA Endograft Instructions for Use
- Maximum aneurysm diameter of 4-5cm
- If female patient with child bearing potential, must have a documented negative pregnancy test within seven(7)days prior to inclusion
- Patient is willing and able to comply with the specified follow-up evaluation
Key exclusion criteria (5 listed)
- Meet any of the Contraindications stated in the Medtronic Vascular AAA Endograft instructions for Use
- Known co-existing condition with a life expectancy of less than 3 years
- Major surgical or interventional procedure (vascular and/or non-vascular)within 30 days prior to study enrollment
- Subjects enrolled in another clinical trial or anticipated to be included into a trial, which may interfere with this study, or subjects already enrolled in this trial before.
- Planned conduit procedure for introduction of endograft
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AneuRx AAA stent graft / Talent AAA stent graftCatheter based stent graft inserted to seal off an abdominal aortic aneurysm | Device | Early Endovascular Repair |
Primary outcome
Number of Subjects That Experienced Rupture or Aneurysm Related Death
Time frame: 3 years
2 secondary outcomes
Aneurysm Growth >0.5 cm
Time frame: 1 year
Secondary Endovascular Procedures Between the 30-day Post Treatment and 3-year Follow-up
Time frame: study termination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23562339Eisenstein EL, Davidson-Ray L, Edwards R, Anstrom KJ, Ouriel K. Economic analysis of endovascular repair versus surveillance for patients with small abdominal aortic aneurysms. J Vasc Surg. 2013 Aug;58(2):302-10. doi: 10.1016/j.jvs.2013.01.038. Epub 2013 Apr 4.
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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.
Kenneth Ouriel, MD principal investigator
New York Presbyterian Hospital
65 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AneuRx AAA stent graft / Talent AAA stent graft in people with ABDOMINAL AORTIC ANEURYSMS, run by Medtronic Cardiovascular at 65 sites 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 6 inclusion and 5 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: stopped early, as of the sponsor's last update on 11 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 65 sites 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?
Yes. Results are posted in the registry (first posted 23 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Subjects That Experienced Rupture or Aneurysm Related Death (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00444821, which also lists 1 linked publication.
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 11 Oct 2021.