Abdominal Aortic AneurysmNCT00739401

Suprarenal Proximal Cuff Study for Treatment of Abdominal Aortic Aneurysm

A study testing Suprarenal Proximal Cuff Extension in people with Abdominal Aortic Aneurysm, run by Endologix at 8 sites in United States.

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 use of a suprarenal extension device during the index AAA procedure to accommodate the patient's anatomy and to prevent or repair leakage. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Abdominal Aortic Aneurysm
What is being tested?: Suprarenal Proximal Cuff Extension
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 44 participants
Where: 8 sitesUnited States
Study dates: 5 May 2006to Aug 2009
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

18 years old
Informed consent understood and signed
Will comply with post-treatment follow-up requirements up to 5 years
Candidate for Powerlink Infrarenal Bifurcated Graft

Who cannot join

Life expectancy < 2 years
Participating in another clinical research study
Pregnant or lactating women
Patient has other medical or psychiatric problems, which in the opinion of the Investigator, precludes them from participating in the Study
Creatinine level > 1.7mg/dl
Renal transplant patient
Patient with > 75% renal artery stenosis and not eligible for PTA/stent intervention prior to suprarenal device fixation

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

Duke University Hospital
Durham, North Carolina, 27710
Deaconess Hospital - The Heart Group
Evansville, Indiana, 47710
East Carolina University - Brody School of Medicine
Greenville, North Carolina, 27834
Mount Sinai Medical Center
Miami Beach, Florida, 33140
Munroe Regional Medical Center
Ocala, Florida, 34474
Orlando Regional Hospital
Orlando, Florida, 32806
Sacred Heart Hospital - Pensacola Research Consultants
Pensacola, Florida, 32504
Methodist Medical Center of Illinois
Peoria, Illinois, 61636

Other trials in United States

About this study

Official title: Endologix Powerlink® Suprarenal Proximal Cuff

The use of a suprarenal extension device during the index AAA procedure to accommodate the patient's anatomy and to prevent or repair leakage.

Conditions: Abdominal Aortic Aneurysm
Being tested: Suprarenal Proximal Cuff Extension
Keywords: AAA, Aneurysm, Suprarenal, Proximal, Cuff, Extension, Endograft, Endovascular repair, EVAR, Endoleak, Type I
Medical subject headings: Aortic Aneurysm, Abdominal, Aneurysm, Endoleak

What participants receive

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

Suprarenal Proximal Cuff ExtensionDevice
Powerlink 25 and 28mm Suprarenal Proximal Extensions augmenting the 25 and 28mm Powerlink bifurcated stent graft

Study groups in NCT00739401
Study group	Role	What they receive
1	Experimental	Test subjects requiring endovascular treatment of abdominal aortic or aorto-iliac aneurysms including a proximal cuff extension. Receives: Device: Suprarenal Proximal Cuff Extension

What is being measured

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

Number of Subjects With Proximal Type I Endoleak
The primary study endpoint is defined as the incidence of type I proximal endoleak at 30 days post-treatment.
Measured: Within 30 Days

Secondary outcomes (6)

Number of Subjects With Major Adverse Events
All cause death, AAA rupture, Conversion / Explant, Coronary Intervention, Myocardial Infarction, Renal Failure, Respiratory Failure, Secondary Procedure, Stroke
Measured: Within 30 days
Number of Participants With Stent Graft Integrity and Performance
Number of Participants with Stent Fracture, Stent Graft Obstruction, Loss of device Integrity and Stent Migration - Core Lab reported Stent Graft Integrity Evaluation Results
Measured: 30 days
Endoleak
Type I (Attachment Site), Type II (Collateral), and Indeterminant type of Endoleak.
Endoleak diagnosis results as reported by the Core Lab.
Measured: 30 days
Aneurysm Morphology Changes
Aneurysm morphology changes (Maximum Daimeter) as reported by CoreLab.
Measured: 30 days
Renal Function
Renal function as measured by serum creatinine. Laboratory results,
Measured: 30 days
Aneurysm Morphology Changes
Aneurysm morphology changes (Volume) as reported by CoreLab.
Measured: 30 days

Timeline

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

5 May 2006Aug 2009

First posted21 Aug 2008 (estimated)
Study start5 May 2006
Primary completionAug 2008
Study completionAug 2009

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.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Abdominal Aortic AneurysmStudies 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: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00739401
Sponsor's protocol ID: CP04-002
Other IDs: IDE G990139
Status last verified: Dec 2021
First submitted: 19 Aug 2008
Last updated: 10 Dec 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Parmer SS, Carpenter JP; Endologix Investigators. Endovascular aneurysm repair with suprarenal vs infrarenal fixation: a study of renal effects. J Vasc Surg. 2006 Jan;43(1):19-25. doi: 10.1016/j.jvs.2005.09.025.
PubMed 16414382
Harlin SA, Beasley RE, Feldman RL, Thompson CS, Williams JB. Endovascular abdominal aortic aneurysm repair using an anatomical fixation technique and concomitant suprarenal orientation: results of a prospective, multicenter trial. Ann Vasc Surg. 2010 Oct;24(7):921-9. doi: 10.1016/j.avsg.2010.05.008.
PubMed 20831993

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

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All Abdominal Aortic Aneurysm trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Endologix Powerlink® Suprarenal Proximal Cuff
ClinicalTrials.gov ID: NCT00739401
Acronym / sponsor ID: CP04-002
Conditions: Abdominal Aortic Aneurysm
Keywords: AAA, Aneurysm, Suprarenal, Proximal, Cuff, Extension, Endograft, Endovascular repair
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: EndologixIndustry (pharma, biotech, devices)
Study start: 5 May 2006 (actual)
Primary completion: Aug 2008 (actual)
Study completion: Aug 2009 (actual)
First posted: 21 Aug 2008 (estimated)
Results: Posted 10 Dec 2021

Clinical summary

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

The use of a suprarenal extension device during the index AAA procedure to accommodate the patient's anatomy and to prevent or repair leakage.

Study design

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

Arm	Type	Receives
1	Experimental	Device: Suprarenal Proximal Cuff ExtensionTest subjects requiring endovascular treatment of abdominal aortic or aorto-iliac aneurysms including a proximal cuff extension.

Who may qualify

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

Key inclusion criteria (4 listed)

18 years old
Informed consent understood and signed
Will comply with post-treatment follow-up requirements up to 5 years
Candidate for Powerlink Infrarenal Bifurcated Graft

Key exclusion criteria (7 listed)

Life expectancy < 2 years
Participating in another clinical research study
Pregnant or lactating women
Patient has other medical or psychiatric problems, which in the opinion of the Investigator, precludes them from participating in the Study
Creatinine level > 1.7mg/dl

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
Suprarenal Proximal Cuff ExtensionPowerlink 25 and 28mm Suprarenal Proximal Extensions augmenting the 25 and 28mm Powerlink bifurcated stent graft	Device	1

Primary outcome

Number of Subjects With Proximal Type I Endoleak
Time frame: Within 30 Days
The primary study endpoint is defined as the incidence of type I proximal endoleak at 30 days post-treatment.

6 secondary outcomes

Number of Subjects With Major Adverse Events
Time frame: Within 30 days
Number of Participants With Stent Graft Integrity and Performance
Time frame: 30 days
Endoleak
Time frame: 30 days
Aneurysm Morphology Changes
Time frame: 30 days
Renal Function
Time frame: 30 days
Aneurysm Morphology Changes
Time frame: 30 days

Results and safety

Results posted to the registry on 10 Dec 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Suprarenal Proximal Cuff Extension	44	3

Primary outcome: Number of Subjects With Proximal Type I Endoleak

Time frame: Within 30 Days. Count of participants. Unit: Participants

Measure	Suprarenal Proximal Cuff Extension n = 42
Value	2

Population analysed: Out of the 44 subjects enrolled 2 subjects withdrew even before reaching the 30day follow-up visit mark. Thus, 42 subjects were analyzed for the primary outcome.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 2 year. All Cause mortality reported through 2 years. SAEs reported through 1 year. Non SAEs reported through 2 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Suprarenal Proximal Cuff Extension	11 of 44 (25%)	12 of 44 (27.3%)	3 of 44

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 16414382Parmer SS, Carpenter JP; Endologix Investigators. Endovascular aneurysm repair with suprarenal vs infrarenal fixation: a study of renal effects. J Vasc Surg. 2006 Jan;43(1):19-25. doi: 10.1016/j.jvs.2005.09.025.
Results publication: PubMed 20831993Harlin SA, Beasley RE, Feldman RL, Thompson CS, Williams JB. Endovascular abdominal aortic aneurysm repair using an anatomical fixation technique and concomitant suprarenal orientation: results of a prospective, multicenter trial. Ann Vasc Surg. 2010 Oct;24(7):921-9. doi: 10.1016/j.avsg.2010.05.008.
Sponsor InformationLink provided by the sponsor.

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RecruitingPhase 4
Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
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Not yet recruitingObservational study
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Enrolling by invitation
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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.

Robert Beasley, MD principal investigator

Icahn School of Medicine at Mount Sinai

William M. Bogey, MD principal investigator

East Carolina University Brody School of Medicine

Robert Feldman, MD principal investigator

Munroe Regional Medical Center

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Suprarenal Proximal Cuff Extension in people with Abdominal Aortic Aneurysm, run by Endologix at 8 sites in United States.

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 7 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 10 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. 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 10 Dec 2021). 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 Subjects With Proximal Type I Endoleak (time frame: Within 30 Days). 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 NCT00739401, which also lists 2 linked publications.

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 10 Dec 2021.