The (PIVOTAL) Study

checkorphan
Learn more about:
Abdominal aortic aneurysm
Related Access Program
Cook – Abdominal aortic aneurysm Cordis Corporation – Abdominal Aortic Aneurysm
Related Clinical Trial
Impact of Intra- and Postoperative Continuous Infusion of Lidocaine on Analgesia in Vascular Anaesthesia Detecting Abdominal Aortic Aneurysms in First Degree Relatives (Adult Offsprings) to AAA Patients (DAAAD) Contrast Enhanced Ultrasound Endoleak Identification and Classification CCR2 AAA Pilot Study NIH CCR2 AAA Study Predicting Endoleaks Following Endovascular Aortic Aneurysm Repair Using 18F-Sodium Fluoride Comparative Study of a Software With the Gold Standard Limiting AAA With Metformin (LIMIT) Trial Deep Learning Applied to Plain Abdominal Radiographic Surveillance After Endovascular Aneurysm Repair (EVAR) of Abdominal Aortic Aneurysm (AAA) Carbon Dioxide Guided Angiography in Endovascular Abdominal Aortic Aneurysm Repair MuLtibranchEd Graft for OPen RepAir of ThoRacoabdominal Aneurysms Aneurysm Diameter and Surgical Outcome Evaluation of the Long Term Efficacy of Endovascular Treatment of Type 2 Endoleaks Point-of-care Ultrasound in Finland BNP and Vascular Surgery Understanding the Role of Autoimmune Disorders on the Initial Presentation of Cardiovascular Disease Heart Rate and Initial Presentation of Cardiovascular Diseases (Caliber) Social Deprivation and Initial Presentation of 12 Cardiovascular Diseases: a CALIBER Study The Effects of Anesthesia on Patients Undergoing Surgery for Repair of a Thoracoabdominal Aneurysm. The Role of Alcohol Consumption in the Aetiology of Different Cardiovascular Disease Phenotypes: a CALIBER Study Body Mass Index and Initial Presentations of Cardiovascular Diseases Totally Percutaneous Approach to Endovascular Treatment of Aortic Aneurysms (PEVAR-PRO) Haemostasis Management of Abdominal Aortic Procedures Overlay of 3D Scans on Live Fluoroscopy for Endovascular Procedures in the Hybrid OR Evaluation of the Safety and Efficacy of the Multilayer Stent Serum Uric Acid Levels and Onset of Cardiovascular Diseases: a CALIBER Study Ethnicity and Onset of Cardiovascular Disease: A CALIBER Study Fenestrated AAA Endovascular Graft Post-Approval Study Preconditioning Shields Against Vascular Events in Surgery Zenith Low Profile AAA Endovascular Graft (ZLP) Clinical Study Terumo Aortic Global Endovascular Registry A Study of Remote Ischaemic Preconditioning in Patients With Atherosclerosis Undergoing Vascular Surgery Preconditioning Shields Against Vascular Events in Surgery Risk Factors in the Initial Presentation of Specific Cardiovascular Disease Syndromes White Blood Cell Counts and Onset of Cardiovascular Diseases: a CALIBER Study Contrast-enhanced Ultrasound in Follow-up After Endovascular Aneurysm Repair Use of Fish Oil to Reduce Inflammation During Endovascular Abdominal Aortic Repair Contrast Enhanced Ultrasound, Endoleak Detection Following EVAR v1.3 Glycemic Control to Prevent Cardiac Morbidity in Vascular Surgery Performance and Safety of a Second Generation Antimicrobial Graft in Abdominal Position AneuFix – Prophylactic Sac Filling ANEUFIX for Endoleak Type II Repair Endurant Evo US Clinical Trial The Use of Carbon Dioxide as a Contrast Media for Performing Endovascular Procedures A Study of the Safety of Targeted AAA Screening Zenith® Low Profile AAA Endovascular Graft Zenith® Low Profile AAA Endovascular Graft Zenith(R) Low Profile AAA Endovascular Graft Clinical Study Hemodynamic Changes After Aortic Aneurysm Treatment With Stent-Graft Zenith® AAA Endovascular Graft Clinical Study Talent Converter Post-Approval Study Arterial Stiffness, Blood Pressure and Cardiac Output Study LIFE Study: Least Invasive Fast-Track EVAR DynaCT in Preoperative Imaging Before Insertion of Stentgraft TriVascular European Union (EU) Abdominal Stent Graft Trial Percutaneous Endovascular Aneurysm Repair (PEVAR) Trial Biomarkers of Aneurysm Wall Strength Post Implant Syndrome After EVAR and EVAS (INSPIRE Study) Control Post Endovascular Treatment of Aortic Aneurisms Through Magnetic Resonance and Ultrasound (SAFEVAR) Estimation of Biomechanical Aortic Wall Properties in Healthy and Aneurysmal Aortas Using Novel Imaging Techniques ANEUFIX for Endoleaks Type II TriVascular Canadian LIFE Study: Least Invasive Fast-Track EVAR (Endovascular Aneurysm Repair) Screening Cardiovascular Patients for Aortic aNeurysms (SCAN) Emergency Department Ultrasound in Renal Colic Endurant Evo International Clinical Trial Physician Modified Endovascular Grafts Talent Aortic Cuff Stent Graft System Compassionate Use Registry Fusion of CT Angiography With 3D Contrast Ultrasound as a Method for Follow up for Endovascular Aneurysm Repair Evaluation of a New Imagingtechnologie for Thrombosis The Effect of Surgery on Central Aortic Pressure & haEmodynamics Study Image Fusion of Preprocedural CTA With Real Time Fluoroscopy to Enhance EVAR Repair Post-operative CT Follow up After Nellix Endoprosthesis Implantation Endovascular Exclusion of TAAA/AAA Utilizing Fenestrated/Branched Stent Grafts Zenith® p-Branch™: Single-Center Study Observatory of Screening Aneurysms of the Abdominal Aorta During Echocardiography. National Epidemiological Survey Female Aneurysm Screening STudy The Pivotal Study of the Aptus Endovascular AAA Repair System Endovascular Treatment of Aorto-iliac Disease Using in Situ Fenestration Interest of a Post-operative Ultrasound With Systematic Use of Ultrasonic Contrast in the Follow-up of Aortic Endoprosthesis: Prospective Study at the University Hospital of Nice Zenith® Fenestrated Abdominal Aortic Aneurysm (AAA) Endovascular Graft Continued Access Study Endovascular Aneurysm Repair (EVAR) Gate Study Powerlink Bifurcated Stent Graft Long-Term Follow-up Study Screening Cardiovascular Patients for Aortic Aneurysms Zenith(R) Fenestrated Abdominal Aortic Aneurysm (AAA) Endovascular Graft Clinical Study Global Fenestrated Anaconda Clinical sTudy TriVascular Post-Market Registry Vasovist Endoleak Study AAA Registry: Clinical Outcomes of Highly Angulated anatomY Treated With the Aorfix™ Stent Graft Italian Multicenter Database for Open Conversions After EVAR Evaluation of the Endovascular Repair for Aortic Aneurysm (EVAR) Program at LHSC Preoperative Methylprednisolone in Endovascular Aortic Repair Prospective Aortic Biobank of POP-STAR E-tegra Stent Graft System in the Treatment of Infra-renal Abdominal Aortic Aneurysms EValuation of Systemic Atherothrombosis in Patients With ARTerial Disease of the Lower Limbs A Clinical Study to Evaluate the Safety and Performance of the Modular AAA Stent-Graft System Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft The Vascutek Custom Fenestrated Anaconda Post-Market Surveillance Study Advanced MRI in AAA Korean Registry of Percutaneous EVAR With INCRAFT Stent Graft for the Treatment of Abdominalaortic Aneurysm (K-INCRAFT) Safety and Efficacy of the SETA LATECBA Stent Graft for EVAR in Subjects With AAA UVA Brain and Aortic Aneurysm Study Acute Technical Outcomes of the Talent Abdominal Aortic Aneurysm (AAA) Stent-Graft Versus Cook Zenith Stent-Graft South American Abdominal Stent Graft Trial Zenith® Spiral-Z® AAA Iliac Leg Graft Post-market Registry AneuRx Post Market Study in the Treatment of AAA Predicting Aneurysm Growth and Rupture With Longitudinal Biomarkers The Boston Scientific ENOVUS Trial The (PIVOTAL) Study Suprarenal Proximal Cuff Study for Treatment of Abdominal Aortic Aneurysm Relation betwEen Abdominal Aorta and Carotid Artery Responses to SymPathetic stimulatiON uSing duplEx Ultrasound ARBITER-II: Aorfix™ Bifurcated Safety and Performance Trial: Phase II, Angulated Vessels Evaluation of Predictors of Aortic Aneurysm Growth and Rupture Compassionate Use of the Incraft® AAA Stent Graft System Aortic Distensibility Randomized Preventive Vascular Screening Trial of 65-74 Year Old Men in the Central Region of Denmark CRD007 for the Treatment of Abdominal Aorta Aneurysm (The AORTA Trial) ACT Guided Heparinization During Open Abdominal Aortic Aneurysm Repair. Cross-sectional Study of Prevalence Rate of Abdominal Aortic Aneurysm in OSAHS Patients From BTCH Mechanism and Prevention of Remote Organ Injury Following Ruptured Aortic Aneurysm Study of Abdominal Aortic Stent Grafts in the Treatment of Infrarenal Abdominal Aortic Aneurysms Study on Anti-inflammatory Effect of Anti-hypertensive Treatment in Patients With Small AAA’s and Mild Hypertension DynaCT Imaging in EVAR: Comparing Clinical Benefit of DynaCT to Multidetector CT as the Current Gold Standard. Zenith® LP Abdominal Aortic Aneurysm (AAA) Post-Market Registry Endovascular Exclusion of Thoracoabdominal and/or Paravisceral Abdominal Aortic Aneurysm Safety and Efficacy of Allogeneic MSCs in Promoting T-regulatory Cells in Patients With Small Abdominal Aortic Aneurysms Post-Market Study to Assess Outcomes of Patients Treated With AFX System Compared to Other EVAR Devices Dutch Randomised Endovascular Aneurysm Management (DREAM-) Trial Metformin Therapy in Non-diabetic AAA Patients Tonometry(1) and Duplex Ultrasound(2) to Predict CV Events in to be Treated Patients With an AAA Tonometry and Duplex Ultrasound to Predict AAA Progression and CV Events in Aneurysm Patients (1-2-3 Trial) Endoprosthesis Treatment Effects on Human Abdominal Aorta Aneurysms (AAA) Metabolic Activity Surviving Aneurysm Surgery: A Pilot Study on Exercise Training in Abdominal Aortic Aneurysm Patients Treovance Stent-Graft With Navitel Delivery System for Patients With Infrarenal Abdominal Aortic Aneurysms Cyclosporine A in Patients With Small Diameter Abdominal Aortic Aneurysms Intraoperative Assessment of Pulsatile Aneurysm Wall Motion During Endovascular Aneurysm Repair Curcumin to Prevent Complications After Elective Abdominal Aortic Aneurysm (AAA) Repair Post Implantation Syndrome and Administration on NSAIDs in Patients Undergoing EVAR for AAA LUCY Study: TriVascular Evaluation of Females Who Are Underrepresented Candidates for Abdominal Aortic Aneurysm Repair Elective Abdominal Aortic Aneurism – Open Versus Endovascular Repair TriVascular Evaluation of Females Who Are Underrepresented Candidates for Abdominal Aortic Aneurysm Repair in Europe Statin Use in Abdominal Aortic Aneurysm Repair GORE® EXCLUDER® Endoprosthesis French Mandatory Registry Endovascular Exclusion of Abdominal Aortic Aneurysms in High Risk Patients Aneurysma Hernia Study – Incidence of Incisional Hernias After Abdominal Aortic Aneurysm Repair Predictors of AAA Expansion and/or Rupture Non-invasive Monitoring of Endovascular Repair of Abdominal Aortic Aneurysm (VBA) Comparison of Beta-blocker Versus Angiotensin Receptor Blocker for Suppression of Aneurysm Expansion in Patients With Small Abdominal Aortic Aneurysm and Hypertension (BASE Trial) Preferences for Open Vs. Endovascular Repair for Abdominal Aortic Aneurysm Pharmacokinetics of CRD007 in Patients With Abdominal Aorta Aneurisms. Study of the Endovascular QUANTUM LP™ Stent Graft System in Abdominal Aortic Aneurysms (AAA) Immediate Management of the Patient With Rupture : Open Versus Endovascular Repair Study of the Glycocalyx in Abdominal Aortic Aneurysm Effect of Pre-operative Exercise in Abdominal Aortic Aneurysms (AAA) Patients. Validation of Fenestrations Positioning by Numerical Simulation Prevalence and Screening of Abdominal Aortic Aneurysms Among Men With Coronary Artery Disease START – Early Thrombocyte Administration to Patients With Ruptured Abdominal Aortic Aneurism Intraoperative Perfusion Patterns of the Sigmoid Colon During Elective Open Abdominal Aortic Aneurysm Repair The Inter and Intra Reliability of Cardiopulmonary Exercise Testing in Abdominal Aortic Aneurysm Patients Prevalence of Carotid Artery Stenosis and Abdominal Aortic Aneurysms in Brussels: a Population-based Screening Study. Screening of Abdominal Aortic Aneurysms Among Male Patients With TIA Symptoms The Nellix® EndoVascular Aneurysm Sealing System for the Treatment of Infrarenal Abdominal Aortic Aneurysms Screening of Abdominal Aortic Aneurysms Among Men With Coronary Artery Disease Cordis Bilateral AAA Device Compared to Open Surgical Repair of Abdominal Aortic Aneurysms (ARIBA) A Large Surgical Registry for Abdominal Aortic Aneurysms (AAA) Circulating microRNAs and Degenerative Abdominal Aorta Aneurysm Follow-up After Endovascular Repair of Abdominal Aortic Aneurysm Abdominal Aortic Aneurysms and Pseudoexfoliation Syndrome The Efficacy of Ticagrelor on Abdominal Aortic Aneurysm (AAA) Expansion Physician-Sponsored IDE for Talent Endoluminal Spring Graft System in Patients With Abdominal Aortic Aneurysms (AAA) Impact of Limb Remote Ischemic Preconditioning on Mortality and Quality of Life During Abdominal Aortic Aneurysm Repair Magnetic Resonance Elastography in Patients With Abdominal Aortic Aneurysms 34mm Cuff Study for Endovascular Repair of Abdominal Aortic Aneurysms Metformin for Abdominal Aortic Aneurysm Growth Inhibition Clinical Study of Abdominal Aortic Aneurysm Exclusion (TALENT Abdominal) A Phase I Evaluation of the Safety of the TriVascular Stent-Graft System in the Treatment of Abdominal Aortic Aneurysms Screening for Abdominal Aortic Aneurysm and Abdominal Aortic Atherosclerosis by Hand-Held Ultrasonography Clinical Study of the Treovance Stent-Graft for Patients With Abdominal Aortic Aneurysms Development of Novel Imaging Markers Predicting the Progression of Abdominal Aortic Aneurysm Using 3D Computed Tomography Structured Exercise Programme and Abdominal Aortic Aneurysm Surgery Study of the Effectiveness of Telmisartan in Slowing the Progression of Abdominal Aortic Aneurysms Evaluation of Effect of Angiotensin-converting Enzyme (ACE) Inhibitors on Small Aneurysm Growth Rate A Prospective Analysis on the Expansion Rates of Abdominal Aortic Aneurysms Reduction of Myocardial Infarction by Preconditioning in Patients With Ruptured Abdominal Aortic Aneurysm Magnetic Resonance Imaging To Predict Outcomes In Aortic Aneurysms Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks A MULTICENTER, OPEN LABEL, PROSPECTIVE, NON-RANDOMIZED STUDY OF INCRAFT™ IN SUBJECTS WITH ABDOMINAL AORTIC ANEURYSMS (INNOVATION) Abdominal Aortic Aneurysm Surgery and Thrombosis Ultra-sound for AAA Screening in Smoking Israeli Arab Men Prophylactic Mesh Implantation After Abdominal Aortic Aneurysm Repair Compassionate Use Treatment for a Single Patient With a Custom Made Branched/Fenestrated Endovascular Device for the Treatment of Complex Abdominal Aortic Aneurysm Comparison of Methods to Improve Abdominal Aortic Aneurysm (AAA) Screening Rates in the Primary Care Setting. Safety Study for the Treatment of Abdominal Aortic Aneurysms Prevention of Incisional Hernia After Elective Open Abdominal Aortic Aneurysm (AAA) Repair Sodium Fluoride Imaging of Abdominal Aortic Aneurysms Biomarker Profiling in Abdominal Aortic Aneurysm Patients Vascutek Anaconda™ Abdominal Aortic Aneurysm (AAA) Post-Market Surveillance Registry Limb Remote Ischemic Preconditioning Reduces Heart and Lung Injury After Abdominal Aortic Aneurysm Repair China Post-market Study of the INCRAFT® AAA Stent Graft System in Subjects With Abdominal Aortic Aneurysms (INITIATION) Screening for Thoracic Aortic Aneurysm Among a Cohort of Patients With a Degenerative Abdominal Aortic Aneurysm A Multicenter, Open Label, Prospective, Non-randomized Study of the InCraft® Stent Graft System in Subjects With Abdominal Aortic Aneurysms (INSPIRATION) Prevention of Endoleaks Using Autologous Platelet Gel on Unruptured Abdominal Aortic Aneurysms Screening for Abdominal Aortic Aneurysm in 65 Year Old Males in Oslo European (EU) Post Approval Study of the INCRAFT® AAA Stent Graft System in Subjects With Abdominal Aortic Aneurysms Prevention of Type II Endoleaks During Endovascular Treatment of Abdominal Aortic Aneurysm: Endovascular Treatment Versus Combination With Coil Embolisation of the Aneurysmal Sac HORIZON CE Pivotal Study to Treat Abdominal Aortic Aneurysm Screening Programme for Abdominal Aortic Aneurysm by Hand-Held-Ultrasonography in Primary Health Care ACZ885 for the Treatment of Abdominal Aortic Aneurysm Measurement of Maximum Diameter of Native Abdominal Aortic Aneurysm by Angio-CT Intact Abdominal Aortic Aneurysm Repair in Portugal The Altura Abdominal Aortic Aneurysm (AAA) Endograft Safety and Feasibility Study

Brief Title

The (PIVOTAL) Study

Official Title

Positive Impact of Endovascular Options for Treating Aneurysms Early (PIVOTAL)

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 Type

Interventional

Primary Outcome

Number of Subjects That Experienced Rupture or Aneurysm Related Death

Secondary Outcome

 Aneurysm Growth >0.5 cm

Condition

ABDOMINAL AORTIC ANEURYSMS

Intervention

AneuRx AAA stent graft / Talent AAA stent graft

Study Arms / Comparison Groups

 Surveillance
Description:

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Device

Estimated Enrollment

728

Start Date

March 2005

Completion Date

January 2010

Primary Completion Date

January 2010

Eligibility 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

          -  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

Gender

All

Ages

40 Years - 90 Years

Accepts Healthy Volunteers

No

Contacts

Kenneth Ouriel, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT00444821

Organization ID

VS-2005-01

Responsible Party

Sponsor

Study Sponsor

Medtronic Endovascular

Collaborators

 The Cleveland Clinic

Study Sponsor

Kenneth Ouriel, MD, Principal Investigator, New York Presbyterian Hospital

Verification Date

April 2018