Abdominal Aortic AneurysmNCT00706394

34mm Cuff Study for Endovascular Repair of Abdominal Aortic Aneurysms

A study testing Endologix Powerlink 34 mm stent graft cuff in people with Abdominal Aortic Aneurysm, run by Endologix at 10 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

Study of anatomical fixation with a 34mm proximal extension 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?: Endologix Powerlink 34 mm stent graft cuff
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: 10 sitesUnited States
Study dates: 10 Aug 2007to Sep 2013
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 or older
Informed consent understood and signed
Will comply with protocol follow-up requirements
Candidate for conventional open surgical repair
Aneurysm outer diameter is one or more of the following:
greater than or equal to 4.0cm

Show all 12Show fewer

greater than or equal to 3.0cm (saccular aneurysm)
greater than or equal to twice the normal aortic outer diameter
rapidly growing (greater than or equal to 5mm over 6 months)
Proximal non-aneurysmal aortic neck fixation length greater than or equal to 1.5cm between the renal arteries and the aneurysm
Non-aneurysmal proximal aortic neck inner diameter between 23 and 32mm
Iliac artery internal diameter greater than or equal to 8 mm

Who cannot join

Life expectancy <2 years
Participating in another clinical study
Pregnant or lactating women
Acutely ruptured/leaking aneurysm
Traumatic vascular injury
Other medical or psychiatric problems

Show all 17Show fewer

Contraindication to non-ionic contrast media or anticoagulants
Coagulopathy or bleeding disorder
Active systemic or localized groin infection
Indispensable inferior mesenteric artery
Connective tissue disease (e.g., Marfan's Syndrome)
Creatinine level >1.7 mg/dl
Renal transplant patient
Proximal attachment site >60º angle to the aneurysm body
Iliac arteries >90º angle
<1.5 cm of non-aneurysmal common iliac artery above the iliac bifurcation on both sides [One internal iliac artery is required to remain patent]
Thrombus >30% at implantation site

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 sites

Sisters of Charity Hospital
Buffalo, New York, 14214
Nebraska Heart Institute
Lincoln, Nebraska, 68526
Baptist Hospital East
Louisville, Kentucky, 40207
Mount Sinai Medical Center
Miami, Florida, 33140
Baptist Cardiac and Vascular Institute
Miami, Florida, 33176
Oklahoma Cardiovascular Associates
Oklahoma City, Oklahoma, 73120
Hospital at the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
William Beaumont Hospital
Royal Oak, Michigan, 48073
St. Joseph Medical Center
Towson, Maryland, 21204
Lexington Medical Center
West Columbia, South Carolina, 29169

Other trials in United States

About this study

Official title: Prospective, Multicenter, Single Arm Phase II Study of the Powerlink 34mm Cuff for the Endovascular Repair of Abdominal Aortic Aneurysms

Study of anatomical fixation with a 34mm proximal extension

Read the detailed description

The 34mm proximal extension stent graft is intended to augment the primary 28mm infrarenal bifurcated stent graft to accommodate patient anatomy (neck diameters up to 32mm) and provide an effective seal to prevent/repair proximal Type I endoleaks.

Conditions: Abdominal Aortic Aneurysm
Being tested: Endologix Powerlink 34 mm stent graft cuff
Keywords: Powerlink, 34mm, Abdominal Aortic Aneurysm, EVAR
Medical subject headings: Aortic Aneurysm, Abdominal

What participants receive

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

Endologix Powerlink 34 mm stent graft cuffDevice
Also called Endologix Powerlink 34mm cuff [model 34-34-80L]
Endovascular abdominal aortic aneurysm repair

Study groups in NCT00706394
Study group	Role	What they receive
A	Experimental	Powerlink 34mm cuff stent graft Receives: Device: Endologix Powerlink 34 mm stent graft cuff

What is being measured

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

Number of Participants With Proximal Type I Endoleak at Each Timepoint
Percentage of patients with Type Ia endoleaks at each timepoint (discharge, 1, 6, 12, 24, 36, 48 and 60 months).
Measured: Five years

Secondary outcomes (9)

Number of Participants With Successful Delivery and Deployment of the Device
Successful delivery and deployment of the device with no complication.
Measured: 1 Month
Number of Participants With Type III Endoleaks at Each Timepoint
Percentage of patients with a Type III endoleaks at the timepoints (1, 6, 12, 24, 36, 48 and 60 Months) as reported by CoreLab.
Measured: 5 Years
Number of Participants With Stent Fracture at Each Timepoint
Percentage of patients with a stent fracture over the timepoints (1, 6, 12, 24, 36, 48 and 60 Months) as reported by the CoreLab.
Measured: 5 Years
Number of Participants With Stent Graft Obstruction at Each Timepoint
Percentage of patients with a stent graft obstruction at each timepoint (1, 6, 12, 24, 36, 48 and 60 Months) as reported by Corelab.
Measured: 5 Years
Number of Participants With Migration at Each Timepoint
Percentage of patients presenting a migration at each timepoint (1, 6, 12, 24, 36, 48, 60 Months) as reported by Corelab.
Measured: 5 Years
Number of Participants With Type II Endoleaks at Each Timepoint
Percentage of patients with Type II endoleak at each time point (1, 6, 12, 24, 36, 48 and 60 Months) as reported by CoreLab.
Measured: 5 Years
Number of Participants With Aneurysm Diameter Change at Each Timepoint
Percentage of patients with a decrease, stable or increase aneurysm diameter at 6, 12, 24, 36, 48 and 60 Months compared to 1 Month as reported by CoreLab.
Measured: 5 Years
Maximum Diameter Measurements
Maximum Diameter changes compared to the pre-operative at each timepoint (1, 6, 12, 24, 36, 48 Months).
Measured: 5 Years
Aneurysm Volume Measurements
Aneurysm Volume changes over each time point (1, 6, 12, 24, 36, 48 and 60 Months) compared to pre-operative as reported by CoreLab.
Measured: 5 Years

Timeline

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

10 Aug 2007Sep 2013

First posted27 Jun 2008 (estimated)
Study start10 Aug 2007
Primary completionSep 2013
Study completionSep 2013

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 (1)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: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00706394
Sponsor's protocol ID: CP03-023
Status last verified: Oct 2021
First submitted: 2 May 2008
Last updated: 1 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Jordan WD Jr, Moore WM Jr, Melton JG, Brown OW, Carpenter JP; Endologix Investigators. Secure fixation following EVAR with the Powerlink XL System in wide aortic necks: results of a prospective, multicenter trial. J Vasc Surg. 2009 Nov;50(5):979-86. doi: 10.1016/j.jvs.2009.05.057. Epub 2009 Aug 12.
PubMed 19679425

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 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective, Multicenter, Single Arm Phase II Study of the Powerlink 34mm Cuff for the Endovascular Repair of Abdominal Aortic Aneurysms
ClinicalTrials.gov ID: NCT00706394
Acronym / sponsor ID: CP03-023
Conditions: Abdominal Aortic Aneurysm
Keywords: Powerlink, 34mm, Abdominal Aortic Aneurysm, EVAR
Study type: Interventional
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: EndologixIndustry (pharma, biotech, devices)
Study start: 10 Aug 2007 (actual)
Primary completion: Sep 2013 (actual)
Study completion: Sep 2013 (actual)
First posted: 27 Jun 2008 (estimated)
Results: Posted 20 Oct 2021

Clinical summary

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

Study of anatomical fixation with a 34mm proximal extension

Detailed description

Study design

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

Arm	Type	Receives
A	Experimental	Device: Endologix Powerlink 34 mm stent graft cuffPowerlink 34mm cuff stent graft

Who may qualify

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

Key inclusion criteria (12 listed)

18 years old or older
Informed consent understood and signed
Will comply with protocol follow-up requirements
Candidate for conventional open surgical repair
Aneurysm outer diameter is one or more of the following:

Key exclusion criteria (17 listed)

Life expectancy <2 years
Participating in another clinical study
Pregnant or lactating women
Acutely ruptured/leaking aneurysm
Traumatic vascular injury

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
Endologix Powerlink 34 mm stent graft cuffAlso: Endologix Powerlink 34mm cuff [model 34-34-80L]Endovascular abdominal aortic aneurysm repair	Device	A

Primary outcome

Number of Participants With Proximal Type I Endoleak at Each Timepoint
Time frame: Five years
Percentage of patients with Type Ia endoleaks at each timepoint (discharge, 1, 6, 12, 24, 36, 48 and 60 months).

9 secondary outcomes

Number of Participants With Successful Delivery and Deployment of the Device
Time frame: 1 Month
Number of Participants With Type III Endoleaks at Each Timepoint
Time frame: 5 Years
Number of Participants With Stent Fracture at Each Timepoint
Time frame: 5 Years
Number of Participants With Stent Graft Obstruction at Each Timepoint
Time frame: 5 Years
Number of Participants With Migration at Each Timepoint
Time frame: 5 Years
Number of Participants With Type II Endoleaks at Each Timepoint
Time frame: 5 Years
Number of Participants With Aneurysm Diameter Change at Each Timepoint
Time frame: 5 Years
Maximum Diameter Measurements
Time frame: 5 Years
Aneurysm Volume Measurements
Time frame: 5 Years

Results and safety

Results posted to the registry on 20 Oct 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
Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy	19	8

Primary outcome: Number of Participants With Proximal Type I Endoleak at Each Timepoint

Time frame: Five years. Count of participants. Unit: Participants

Measure	Single Arm 34mm Infrarenal Cuff for Treatment of Patients With Larger Aortic Neck Anatomy n = 19
Discharge	1
1 Month	0
6 Months	0
12 Months	0
24 Months	0
48 Months	0
60 Months	0

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 5 Years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Powerlink 34mm Cuff Stent Graft	14 of 19 (73.7%)	7 of 19 (36.8%)	6 of 19

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 19679425Jordan WD Jr, Moore WM Jr, Melton JG, Brown OW, Carpenter JP; Endologix Investigators. Secure fixation following EVAR with the Powerlink XL System in wide aortic necks: results of a prospective, multicenter trial. J Vasc Surg. 2009 Nov;50(5):979-86. doi: 10.1016/j.jvs.2009.05.057. Epub 2009 Aug 12.

Related trials for Abdominal Aortic Aneurysm

Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
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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Not yet recruitingObservational study
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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.

Edward Y Woo, MD principal investigator

Hospital at the University of Pennsylvania, Philadelphia, PA 19104, United States

O. W. Brown, MD principal investigator

William Beaumont Hospital, Royal Oak, MI 48073, United States

James G. Melton, DO principal investigator

Oklahoma Cardiovascular Research Group, Oklahoma City, OK 73120, United States

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

Questions about this trial

What is this clinical trial studying?

A study testing Endologix Powerlink 34 mm stent graft cuff in people with Abdominal Aortic Aneurysm, run by Endologix at 10 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 12 inclusion and 17 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 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 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 20 Oct 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 Participants With Proximal Type I Endoleak at Each Timepoint (time frame: Five years). 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 NCT00706394, which also lists 1 linked publication.

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 1 Nov 2021; AzTrials last refreshed its copy on 8 Nov 2026.