An interventional study of Zenith Low Profile AAA Endovascular Graft and ancillary components in Abdominal Aortic Aneurysms, Iliac Aneurysms and Aortoiliac Aneurysms, sponsored by Cook Research Incorporated. Completed at 37 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-19.
Sponsored by Cook Research Incorporated · Not applicable, Interventional, and Treatment
The Zenith® Low Profile AAA Endovascular Graft Clinical Study is a clinical trial to study the safety and effectiveness of the Zenith® Low Profile AAA Endovascular Graft used in conjunction with the Zenith® Spiral-Z® AAA Iliac Leg Graft to treat abdominal aortic, aortoiliac, and iliac aneurysms.
960 studies on the registry are indexed under Aneurysm; 175 are open to participants now.
This study's enrollment of 62 is below the median of 72 across 462 interventional studies indexed under Aneurysm.
Browse Aneurysm studies →Cook Research Incorporated is the lead sponsor of 33 studies on the registry; 4 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 5 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subject has at least one of the following
Exclusion Criteria:
The Zenith Low Profile AAA Endovascular Graft and ancillary components
Device: Zenith Low Profile AAA Endovascular Graft and ancillary components
Treatment of patients with abdominal aortic, aortoiliac, or iliac aneurysms having morphology suitable for endovascular repair
Number of Patients Without Major Adverse Events Within 30 Days
Major adverse events include all-cause death, Q-wave MI, renal failure requiring dialysis, paralysis, stroke, bowel ischemia, re-intubation
Time frame: 30 days
Number of Patients With Device Success
Device success will be measured with none of the following: type I or III endoleaks requiring re-intervention, graft limb occlusion, aneurysm rupture or conversion to open surgical repair, aneurysm enlargement greater than 0.5 cm
Time frame: 12 months
| Milestone | Endovascular Graft |
|---|---|
| Started | 62 |
| 1-month follow-up | 62 |
| 12-month follow-up | 61 |
| Completed | 42 |
| Not completed | 20 |
| Withdrew: Death | 13 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Withdrawal by subject | 6 |
Major adverse events include all-cause death, Q-wave MI, renal failure requiring dialysis, paralysis, stroke, bowel ischemia, re-intubation
| Participants | Endovascular Graft |
|---|---|
| Number of Patients Without Major Adverse Events Within 30 Days | 62 |
Device success will be measured with none of the following: type I or III endoleaks requiring re-intervention, graft limb occlusion, aneurysm rupture or conversion to open surgical repair, aneurysm enlargement greater than 0.5 cm
| Participants | Endovascular Graft |
|---|---|
| Number of Patients With Device Success | 57 |
Collected over 5 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Endovascular Graft | 13/62 (21%) | 49/62 (79%) | 7/62 (11.3%) |
| Event | Endovascular Graft |
|---|---|
| PneumoniaInfections and infestations | 9/62 |
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 7/62 |
| ArrhythmiaCardiac disorders | 6/62 |
| Myocardial ischaemiaCardiac disorders | 5/62 |
| Stent-graft endoleakGeneral disorders | 5/62 |
| Vascular stent occlusionGeneral disorders | 5/62 |
| Cardiac failure congestiveCardiac disorders | 3/62 |
| Myocardial infarctionCardiac disorders | 3/62 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 3/62 |
| Cardiac arrestCardiac disorders | 2/62 |
| Event | Endovascular Graft |
|---|---|
| ArrhythmiaCardiac disorders | 4/62 |
| Stent-graft endoleakGeneral disorders | 4/62 |
| Age, Continuous(years) | Endovascular Graft |
|---|---|
| Mean | 70.5 ± 8.9 |
| Sex: Female, Male(Participants) | Endovascular Graft |
|---|---|
| Female | 4 |
| Male | 58 |
| Race (NIH/OMB)(Participants) | Endovascular Graft |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 61 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Endovascular Graft |
|---|---|
| United States | 62 |
| Diabetes(Participants) | Endovascular Graft |
|---|---|
| Yes | 15 |
| No | 47 |
| Smoking Status(Participants) | Endovascular Graft |
|---|---|
| Current | 16 |
| Past | 40 |
| Never | 6 |
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This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Cook Research Incorporated