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The (PIVOTAL) Study

This study has been terminated.
(Interim analysis of Primary Endpoint completed)
Sponsor:
Collaborator:
The Cleveland Clinic
Information provided by:
Medtronic Vascular
ClinicalTrials.gov Identifier:
NCT00444821
First received: March 6, 2007
Last updated: February 4, 2010
Last verified: February 2010
History of Changes
  Purpose

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:

U.S. FDA Resources

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
  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00444821

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

No publications provided

Responsible Party: Simona Zanetti, MD / VP of Clinical Research, Medtronic Vascular
ClinicalTrials.gov 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:
AAA
Aneurysm
AneuRx
Talent

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
 Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on May 22, 2013