Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

The (PIVOTAL) Study

This study has been terminated.
(Interim analysis of Primary Endpoint completed)
The Cleveland Clinic
Information provided by:
Medtronic Vascular Identifier:
First received: March 6, 2007
Last updated: February 4, 2010
Last verified: February 2010

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.

Condition Intervention Phase
Abdominal Aortic Aneurysms
Device: AneuRx AAA stent graft / Talent AAA stent graft
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Positive Impact of Endovascular Options for Treating Aneurysms Early (PIVOTAL)

Resource links provided by NLM:

Further study details as provided by Medtronic Vascular:

Primary Outcome Measures:
  • To determine whether repair of small aneurysms is superior to surveillance with respect to the frequency of rupture or aneurysm related deaths. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Aneurysm shrinkage or growth [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Secondary endovascular procedures between the 30-day post treatment and 1-year follow-up. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 728
Study Start Date: March 2005
Study Completion Date: January 2010
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: AneuRx AAA stent graft / Talent AAA stent graft
    Catheter based stent graft inserted to seal off an abdominal aortic aneurysm

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 40 to 90 years of age
  • Meet all indications for use as stated in the Medtronic Vascular AAA Endograft Instructions for Use
  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00444821

  Show 65 Study Locations
Sponsors and Collaborators
Medtronic Vascular
The Cleveland Clinic
Principal Investigator: Kenneth Ouriel, MD New York Presbyterian Hospital
  More Information

No publications provided by Medtronic Vascular

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Simona Zanetti, MD / VP of Clinical Research, Medtronic Vascular Identifier: NCT00444821     History of Changes
Other Study ID Numbers: VS-2005-01
Study First Received: March 6, 2007
Last Updated: February 4, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Medtronic Vascular:

Additional relevant MeSH terms:
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Aortic Diseases
Cardiovascular Diseases
Vascular Diseases processed this record on November 25, 2014