NCT00444821TerminatedNot Applicable
Positive Impact of Endovascular Options for Treating Aneurysms Early (PIVOTAL)
Medtronic Cardiovascular65 sites in 1 country728 target enrollmentStarted: March 1, 2005Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 728
- Locations
- 65
- Primary Endpoint
- Number of Subjects That Experienced Rupture or Aneurysm Related Death
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- 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
- •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
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
Outcomes
Primary Outcomes
Number of Subjects That Experienced Rupture or Aneurysm Related Death
Time Frame: 3 years
Secondary Outcomes
- Aneurysm Growth >0.5 cm(1 year)
- Secondary Endovascular Procedures Between the 30-day Post Treatment and 3-year Follow-up(study termination)
Investigators
Study Sites (65)
Loading locations...
Similar Trials
Completed
Not Applicable
Efficacy and Safety of Endovascular Recanalization for Acute Basilar Artery Occlusion With Extended Time Window (ANGEL-BAO)Acute Ischemic StrokeBasilar Artery OcclusionNCT06101667Beijing Tiantan Hospital224
Completed
Not Applicable
Evaluation of STaged Endovascular Aneurysm Repair in the Management of Thoracoabdominal Pathology by Means of Branched and Fenestrated Devices.(STEAR)Thoracoabdominal AneurysmNCT03342755IRCCS San Raffaele50
Completed
Not Applicable
Best Endovascular vs. Best Surgical Therapy in Patients With Critical Limb IschemiaCritical Limb IschemiaNCT02060630Carelon Research1,843
Unknown
Not Applicable
Efficacy and Safety Comparison of the Endovascular and the Hybrid Methods for the Treatment of Prolonged Atherosclerotic Lesions of the Femoral-popliteal Segment Above the Knee, TASC II, Type DIschemia LimbSuperficial Femoral Artery OcclusionPopliteal Artery OcclusionStent ComplicationAtherosclerosisNCT04590131Meshalkin Research Institute of Pathology of Circulation100
Completed
Phase 3
Endovascular Treatment With or Without Preceding Intravenous Tenecteplase (TNK) in Patients With Late-window acUte Ischemic Stroke Due to Middle Cerebral Artery OcclusionIschemic Stroke, AcuteThrombolysisEndovascular TreatmentNCT06221371Beijing Tiantan Hospital391