Abdominal Aortic AneurysmsNCT02535065

Zenith® Low Profile AAA Endovascular Graft

A study testing Zenith Low Profile AAA Endovascular Graft and ancillary components in people with Abdominal Aortic Aneurysms and Iliac Aneurysms, run by Cook Research Incorporated at 37 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Abdominal Aortic Aneurysms, Iliac Aneurysms, Aortoiliac Aneurysms
What is being tested?: Zenith Low Profile AAA Endovascular Graft and ancillary components
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 62 participants
Where: 37 sitesin 2 countries
Study dates: Aug 2014to 27 Jan 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject has at least one of the following
Aortic or aortoiliac aneurysm
Iliac aneurysm
Aneurysm with a history of growth

Who cannot join

Less than 18 years of age
Inability or refusal to give informed consent
Disease considerations that would compromise patient safety or study outcomes
Pregnant of breastfeeding or planning on becoming pregnant with 60 months
Unwilling to comply with the follow-up schedule

Trial locations and contacts

37 sites in 2 countries.

Country

City, postcode or hospital

37 sites in 2 countries

United States36 sites

Summa Akron
Akron, Ohio, 44309
Piedmont Hospital
Atlanta, Georgia, 30309
University of Colorado
Aurora, Colorado, 80045
Bend Memorial Clinic
Bend, Oregon, 97701
St. Vincent's Heart and Vascular Center
Billings, Montana, 59101
Massachusetts General
Boston, Massachusetts, 02114
Cooper University Hospital
Camden, New Jersey, 08103
Charleston Area Medical Center
Charleston, West Virginia, 25304
Good Samaritan-Trihealth
Cincinnati, Ohio, 45220
Morton Plant Hospital
Clearwater, Florida, 33756
Missouri Heart Center
Columbia, Missouri, 65201
University of Florida
Gainesville, Florida, 32610
Hartford Hospital
Hartford, Connecticut, 06102
Borgess Research Institute
Kalamazoo, Michigan, 49048
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601
Baptist Health Louisville
Louisville, Kentucky, 40207
Baptist Memorial Hospital-Memphis
Memphis, Tennessee, 38120
New York University - Langone Medical Center
New York, New York, 10016
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
Sentara Vascular Specialists
Norfolk, Virginia, 23507
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
Mayo Clinic Rochester
Rochester, Minnesota, 55905
University of Rochester
Rochester, New York, 14642
Wm Beaumont Hospital
Royal Oak, Michigan, 48073
University of Washington-Harborview Medical Center
Seattle, Washington, 98104
St. John's Mercy Medical Center
St Louis, Missouri, 63141
Stanford University Medical Center
Stanford, California, 94305
SUNY at Stony Brook Hospital
Stony Brook, New York, 11794
SUNY Upstate
Syracuse, New York, 13210
Washington Hospital Center
Washington D.C., District of Columbia, 20010
Aspirus Wausau
Wausau, Wisconsin, 54401
Iowa Heart Center
West Des Moines, Iowa, 50266
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 25157
University of Massachusetts Medical School
Worcester, Massachusetts, 01655

Other trials in United States

Canada1 site

Hamilton General Hospital
Hamilton, Ontario, L8L2X2

Other trials in Canada

About this study

Official title: Clinical Study Plan for the Zenith® Low Profile AAA Endovascular Graft

Conditions: Abdominal Aortic Aneurysms, Iliac Aneurysms, Aortoiliac Aneurysms
Being tested: Zenith Low Profile AAA Endovascular Graft and ancillary components
Keywords: Low Profile, Abdominal Aortic Aneurysms, Endovascular
Medical subject headings: Aortic Aneurysm, Abdominal, Iliac Aneurysm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Zenith Low Profile AAA Endovascular Graft and ancillary componentsDevice
Treatment of patients with abdominal aortic, aortoiliac, or iliac aneurysms having morphology suitable for endovascular repair

Study groups in NCT02535065
Study group	Role	What they receive
Endovascular Graft	Experimental	The Zenith Low Profile AAA Endovascular Graft and ancillary components Receives: Device: Zenith Low Profile AAA Endovascular Graft and ancillary components

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 201427 Jan 2021

First posted28 Aug 2015 (estimated)
Study startAug 2014
Primary completion23 Jan 2017
Study completion27 Jan 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Abdominal Aortic AneurysmsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 62 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02535065
Sponsor's protocol ID: 08-013 Spiral-Z
Status last verified: Mar 2022
First submitted: 26 Aug 2015
Last updated: 19 Apr 2022
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal
Not yet recruitingObservational study
Aortic Size and Height Indices in Abdominal Aortic Aneurysms
Abdominal Aortic Aneurysm, Abdominal Aortic Aneurysm, Ruptured
Not yet recruitingObservational study
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
Complex Aortic Aneurysms, Thoracoabdominal Aneurysm
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm
Active, not recruiting
ANEUFIX for Endoleak Type II Repair
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All Abdominal Aortic Aneurysms trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Study Plan for the Zenith® Low Profile AAA Endovascular Graft
ClinicalTrials.gov ID: NCT02535065
Acronym / sponsor ID: 08-013 Spiral-Z
Conditions: Abdominal Aortic Aneurysms, Iliac Aneurysms, Aortoiliac Aneurysms
Keywords: Low Profile, Abdominal Aortic Aneurysms, Endovascular
Study type: Interventional
Recruitment status: Completed
Enrolment: 62 participants (actual)
Lead sponsor: Cook Research IncorporatedIndustry (pharma, biotech, devices)
Study start: Aug 2014
Primary completion: 23 Jan 2017 (actual)
Study completion: 27 Jan 2021 (actual)
First posted: 28 Aug 2015 (estimated)
Results: Posted 6 Jun 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Endovascular Graft	Experimental	Device: Zenith Low Profile AAA Endovascular Graft and ancillary componentsThe Zenith Low Profile AAA Endovascular Graft and ancillary components

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Subject has at least one of the following

Key exclusion criteria (5 listed)

Less than 18 years of age
Inability or refusal to give informed consent
Disease considerations that would compromise patient safety or study outcomes
Pregnant of breastfeeding or planning on becoming pregnant with 60 months
Unwilling to comply with the follow-up schedule

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Zenith Low Profile AAA Endovascular Graft and ancillary componentsTreatment of patients with abdominal aortic, aortoiliac, or iliac aneurysms having morphology suitable for endovascular repair	Device	Endovascular Graft

Primary outcome

Number of Patients Without Major Adverse Events Within 30 Days
Time frame: 30 days
Major adverse events include all-cause death, Q-wave MI, renal failure requiring dialysis, paralysis, stroke, bowel ischemia, re-intubation
Number of Patients With Device Success
Time frame: 12 months
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

Results and safety

Results posted to the registry on 6 Jun 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Endovascular Graft	62	42

Primary outcome: Number of Patients Without Major Adverse Events Within 30 Days

Time frame: 30 days. Count of participants. Unit: Participants

Measure	Endovascular Graft n = 62
Value	62

Primary outcome: Number of Patients With Device Success

Time frame: 12 months. Count of participants. Unit: Participants

Measure	Endovascular Graft n = 62
Value	57

Adverse events

Time frame: 5 years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Endovascular Graft	49 of 62 (79%)	7 of 62 (11.3%)	13 of 62

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Abdominal Aortic Aneurysms

RecruitingPhase 4
Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal
Not yet recruitingObservational study
Aortic Size and Height Indices in Abdominal Aortic Aneurysms
Abdominal Aortic Aneurysm, Abdominal Aortic Aneurysm, Ruptured
Not yet recruitingObservational study
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
Complex Aortic Aneurysms, Thoracoabdominal Aneurysm
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm
Active, not recruiting
ANEUFIX for Endoleak Type II Repair
Abdominal Aortic Aneurysm, Endoleak

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

37 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients Without Major Adverse Events Within 30 Days (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02535065.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2022.