Abdominal Aortic AneurysmNCT00543270
Powerlink Bifurcated Stent Graft Long-Term Follow-up Study
A study testing Powerlink infrarenal bifurcated stent graft delivery system and Open Surgery in people with Abdominal Aortic Aneurysm, run by Endologix at 14 sites in United States.
Trial summary
Endologix Infrarenal Bifurcated Stent Graft Study 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?
- Powerlink infrarenal bifurcated stent graft delivery system and Open Surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 14 sitesUnited States
- Study dates
- Oct 2005to Nov 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- All surviving patients from the original study cohort who received the Powerlink device
- All surviving patients from the original study cohort who were assigned to the open surgical control arm
Who cannot join
None listed.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Cleveland Clinic
Cleveland, Ohio, 44195
Mercy Hospital
Des Moines, Iowa, 50314
Greenville Hospital System
Greenville, South Carolina, 29605
Advanced Vascular Associates
Morristown, New Jersey, 07960
Vascular and Transplant Specialists
Norfolk, Virginia, 23510
Oklahoma Cardiovascular Research Group
Oklahoma City, Oklahoma, 73120
University of Illinois School of Medicine
Peoria, Illinois, 61604
University Hospital of Pennsylvania
Philadelphia, Pennsylvania, 19104
Arizona Heart Institute
Phoenix, Arizona, 85006
Mayo Clinic
Rochester, Minnesota, 55905
Heart Hospital of South Dakota
Sioux Falls, South Dakota, 57108
SIU School of Medicine
Springfield, Illinois, 62702
Barnes Jewish Hospital
St Louis, Missouri, 63110
Harbor-UCLA Medical Center
Torrance, California, 90506
About this study
Official title: Endologix Powerlink Long-Term Follow-up Study
Endologix Infrarenal Bifurcated Stent Graft Study
- Conditions
- Abdominal Aortic Aneurysm
- Being tested
- Powerlink infrarenal bifurcated stent graft delivery system, Open Surgery
- Keywords
- EVAR, AAA, Aneurysm, Powerlink
- Medical subject headings
- Aortic Aneurysm, Abdominal, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Powerlink infrarenal bifurcated stent graft delivery systemDevice
Also called Powerlink Stent Graft Delivery System
Endovascular abdominal aortic aneurysm repair
Open SurgeryProcedure or surgery
Open surgical abdominal aortic aneurysm repair
| Study group | Role | What they receive |
|---|---|---|
| Endovascular Repair - EVAR (Powerlink System) | Experimental | EVAR (Powerlink System) Receives: Device: Powerlink infrarenal bifurcated stent graft delivery system |
| Open Surgical Control | Active comparator | Open Surgical Control Receives: Procedure: Open Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
No of Subjects with Major adverse events
Aneurysm-related mortality, aneurysm rupture, conversion to open repair, coronary intervention, myocardial infarction, renal failure, respiratory failure, secondary procedure, and stroke
Measured: At 1 Year
All Cause Mortality
No of deaths reported through 1 year
Measured: At 1 Year
Secondary outcomes (17)
Stent Graft Performance
Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration
Measured: 30 Days
Stent Graft Performance
Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration
Measured: 6 Months
Stent Graft Performance
Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration
Measured: Year 1
Stent Graft Performance
Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration
Measured: Year 2
Stent Graft Performance
Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration
Measured: Year 3
Stent Graft Performance
Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration
Measured: Year 4
Stent Graft Performance
Total number of Subjects with Stent fracture, Stent Graft Migration, Stent Graft patency and Device Migration
Measured: Year 5
Clinical Utility Outcomes
Estimated anesthesia time, fluoroscopy time, procedure time
Measured: During the Procedure
Clinical Utility Outcomes
Estimated blood loss (ml) and contrast volume (ml). Estimated blood loss records the approximate amount of blood that the patient lost during the surgery (ml) and contract volume is the volume of the contrast (ml) calculated during the procedure.
Measured: During the Procedure
Clinical Utility Outcomes
Estimated ICU time
Measured: up to 1 week
Clinical Utility Outcomes
Estimated Hospitalization Time
Measured: up to 1 week
Aneurysm Morphology
Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to 6 Months
Measured: 6 Months
Aneurysm Morphology
Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to Year 1
Measured: Year 1
Aneurysm Morphology
Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to Year 2
Measured: Year 2
Aneurysm Morphology
Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to Year 3
Measured: Year 3
Aneurysm Morphology
Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to Year 4
Measured: Year 4
Aneurysm Morphology
Change in aneurysm sac diameter from first post-procedural CT scan (30 days) to Year 5
Measured: Year 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2007 (estimated)
- Study startOct 2005
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endologix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rodney White, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00543270
- Sponsor's protocol ID
- TP00-005/CP04-001
- Status last verified
- Sep 2021
- First submitted
- 10 Oct 2007
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Carpenter JP. The Powerlink bifurcated system for endovascular aortic aneurysm repair: four-year results of the US multicenter trial. J Cardiovasc Surg (Torino). 2006 Jun;47(3):239-43.
PubMed 16760859Parmer 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 16414382Wang GJ, Carpenter JP. EVAR in small versus large aneurysms: does size influence outcome? Vasc Endovascular Surg. 2009 Jun-Jul;43(3):244-51. doi: 10.1177/1538574408327570. Epub 2008 Dec 16.
PubMed 19088132Wang GJ, Carpenter JP; Endologix Investigators. The Powerlink system for endovascular abdominal aortic aneurysm repair: six-year results. J Vasc Surg. 2008 Sep;48(3):535-45. doi: 10.1016/j.jvs.2008.04.031. Epub 2008 Jul 16.
PubMed 18635335
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endologix Powerlink Long-Term Follow-up Study
- ClinicalTrials.gov ID
- NCT00543270
- Acronym / sponsor ID
- TP00-005/CP04-001
- Conditions
- Abdominal Aortic Aneurysm
- Keywords
- EVAR, AAA, Aneurysm, Powerlink
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- EndologixIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 12 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Endologix Infrarenal Bifurcated Stent Graft Study
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endovascular Repair - EVAR (Powerlink System) | Experimental | Device: Powerlink infrarenal bifurcated stent graft delivery systemEVAR (Powerlink System) |
| Open Surgical Control | Active comparator | Procedure: Open SurgeryOpen Surgical Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All surviving patients from the original study cohort who received the Powerlink device
- All surviving patients from the original study cohort who were assigned to the open surgical control arm
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Powerlink infrarenal bifurcated stent graft delivery systemAlso: Powerlink Stent Graft Delivery SystemEndovascular abdominal aortic aneurysm repair | Device | Endovascular Repair - EVAR (Powerlink System) |
| Open SurgeryOpen surgical abdominal aortic aneurysm repair | Procedure or surgery | Open Surgical Control |
Primary outcome
No of Subjects with Major adverse events
Time frame: At 1 Year
Aneurysm-related mortality, aneurysm rupture, conversion to open repair, coronary intervention, myocardial infarction, renal failure, respiratory failure, secondary procedure, and stroke
All Cause Mortality
Time frame: At 1 Year
No of deaths reported through 1 year
17 secondary outcomes
Stent Graft Performance
Time frame: 30 Days
Stent Graft Performance
Time frame: 6 Months
Stent Graft Performance
Time frame: Year 1
Stent Graft Performance
Time frame: Year 2
Stent Graft Performance
Time frame: Year 3
Stent Graft Performance
Time frame: Year 4
Stent Graft Performance
Time frame: Year 5
Clinical Utility Outcomes
Time frame: During the Procedure
Clinical Utility Outcomes
Time frame: During the Procedure
Clinical Utility Outcomes
Time frame: up to 1 week
Clinical Utility Outcomes
Time frame: up to 1 week
Aneurysm Morphology
Time frame: 6 Months
Aneurysm Morphology
Time frame: Year 1
Aneurysm Morphology
Time frame: Year 2
Aneurysm Morphology
Time frame: Year 3
Aneurysm Morphology
Time frame: Year 4
Aneurysm Morphology
Time frame: Year 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
- Results publication: PubMed 16760859Carpenter JP. The Powerlink bifurcated system for endovascular aortic aneurysm repair: four-year results of the US multicenter trial. J Cardiovasc Surg (Torino). 2006 Jun;47(3):239-43.
- Results publication: 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 19088132Wang GJ, Carpenter JP. EVAR in small versus large aneurysms: does size influence outcome? Vasc Endovascular Surg. 2009 Jun-Jul;43(3):244-51. doi: 10.1177/1538574408327570. Epub 2008 Dec 16.
- Results publication: PubMed 18635335Wang GJ, Carpenter JP; Endologix Investigators. The Powerlink system for endovascular abdominal aortic aneurysm repair: six-year results. J Vasc Surg. 2008 Sep;48(3):535-45. doi: 10.1016/j.jvs.2008.04.031. Epub 2008 Jul 16.
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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.
Rodney White, MD principal investigator
University of California, Los Angeles
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Powerlink infrarenal bifurcated stent graft delivery system and Open Surgery in people with Abdominal Aortic Aneurysm, run by Endologix at 14 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 2 inclusion and 0 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 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
No of Subjects with Major adverse events (time frame: At 1 Year). 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 NCT00543270, which also lists 4 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 5 Oct 2021.