Fenestrated AAA Endovascular Graft Post-Approval Study

NCT01990950 — Not applicable, Completed, 21 participants, Cook Research Incorporated
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Evaluation of the Long-term Safety and Performance of the Zenith® Fenestrated Abdominal Aortic Aneurysm (AAA) Endovascular Graft Post-Approval Study

RegistryNCT01990950
StatusCompleted
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, treatment
Enrollment21 (Actual)
SponsorCook Research Incorporated (Industry)
ConditionsAbdominal Aortic Aneurysm (AAA), Aorto-iliac Aneurysm, Juxtarenal Aneurysm
InterventionsZenith® Fenestrated AAA Endovascular Graft (Device)
Datesstart 2014-03-01, primary completion 2020-10-12, completion 2020-10-12, first posted 2013-11-25, last updated 2021-10-05
Locations6 sites in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Abdominal Aortic Aneurysm (AAA) All trials for Aorto-iliac Aneurysm All trials of Zenith® Fenestrated AAA Endovascular Graft

-Summary

This post-market study is approved by the US FDA to evaluate the long-term safety and performance of the Zenith® Fenestrated AAA Endovascular Graft.

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+Arms and interventions

ArmTypeInterventionsDescription
Zenith® Fenestrated AAA Endovascular GraftExperimentalDevice: Zenith® Fenestrated AAA Endovascular Graft
  • Zenith® Fenestrated AAA Endovascular Graft (Device): The Zenith® Fenestrated AAA Endovascular Graft with the H\&L-B One-Shot™ Introduction System is indicated for the endovascular treatment of patients with abdominal aortic or aortoiliac aneursyms having morphology suitable for endovascular repair

+Outcome measures

Primary outcomes

  • Treatment Success : AAA Related Mortality [5 years]: patients treated with the Zenith® Fenestrated AAA Endovascular Graft will have a rate of aneurysm-related mortality at 5 years that meets a performance goal of 18% ,

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* abdominal aortic and aortoiliac aneursyms with a diameter greater than or equal to 5 cm
* aortic or aortoiliac aneurysm with a history of growth greater than or equal to 0.5 cm per year, or clinical indication for AAA repair

Exclusion Criteria:

* proximal neck less than 4mm or greater than or equal to 15 mm in length unless otherwise compromised to preclude seal
* renal artery stenosis greater than 50 percent

+Posted results

Participant flow

MilestoneZenith® Fenestrated AAA Endovascular Graft
Started21
Completed10
Not completed11

Outcome results

  • Treatment Success : AAA Related Mortality (Primary), Count of participants, Participants: Zenith® Fenestrated AAA Endovascular Graft 0

Adverse events

Time frame: 5 years

ArmDeathsSerious adverse eventsOther adverse events
Zenith® Fenestrated AAA Endovascular Graft3/21 (14.3%)11/21 (52.4%)13/21 (61.9%)

Serious adverse events by term

TermOrgan systemZenith® Fenestrated AAA Endovascular Graft
ArrhythmiaCardiac disorders1/21
Atrial fibrillationCardiac disorders2/21
Atrial flutterCardiac disorders1/21
Atrioventricular block second degreeCardiac disorders1/21
Cardiac failure congestiveCardiac disorders1/21
Myocardial infarctionCardiac disorders1/21
Myocardial ischaemiaCardiac disorders3/21
Pancreatitis acuteGastrointestinal disorders1/21
Retroperitoneal haematomaGastrointestinal disorders1/21
Stent-graft endoleakGeneral disorders2/21
Bile duct stoneHepatobiliary disorders1/21
Gallbladder massHepatobiliary disorders1/21
Biliary tract infectionInfections and infestations1/21
SepsisInfections and infestations1/21
Acetabulum fractureInjury, poisoning and procedural complications1/21
FallInjury, poisoning and procedural complications1/21
Humerus fractureInjury, poisoning and procedural complications1/21
InjuryInjury, poisoning and procedural complications1/21
Vascular access site pseudoaneurysmInjury, poisoning and procedural complications1/21
Invasive ductal breast carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/21
Intracranial aneurysmNervous system disorders1/21
Acute kidney injuryRenal and urinary disorders1/21
Renal tubular necrosisRenal and urinary disorders1/21
DialysisSurgical and medical procedures1/21
TransfusionSurgical and medical procedures1/21
Aortic aneurysmVascular disorders1/21
Aortic aneurysm ruptureVascular disorders1/21
Aortic dissectionVascular disorders1/21
Peripheral artery aneurysmVascular disorders1/21

Other adverse events by term

TermOrgan systemZenith® Fenestrated AAA Endovascular Graft
Atrial fibrillationCardiac disorders2/21
Cardiac failure congestiveCardiac disorders2/21
ConstipationGastrointestinal disorders2/21
Stent-graft endoleakGeneral disorders2/21
PneumoniaInfections and infestations2/21
TransfusionSurgical and medical procedures2/21
Aortic aneurysmVascular disorders3/21
Renal infarctRenal and urinary disorders3/21
Myocardial ischaemiaCardiac disorders3/21

+Locations (6)

FacilityCityCountryStatus
University of California-DavisSacramento, CaliforniaUnited States
University of ColoradoAurora, ColoradoUnited States
Borgess Research InstituteKalamazoo, MichiganUnited States
Newark Beth Israel Medical CenterNewark, New JerseyUnited States
Wake Forest University HealthWinston-Salem, North CarolinaUnited States
University of Wisconsin Hospital and ClinicsMadison, WisconsinUnited States

+Study documents