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Aortic AneurysmPhase 2NCT00549354

Abdominal Aortic/Aorto-Iliac Aneurysm Endoluminal Graft Study

A Phase 2 study testing Endoluminal Graft in people with Aortic Aneurysm, run by Arizona Heart Institute at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The Bifurcated PowerLink System is intended to provide a permanent alternative conduit for blood flow within a patient's abdominal vascular system, which excludes the aneurysmal sac from blood flow and pressure. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Aortic Aneurysm
What is being tested?
Endoluminal Graft
Type of treatment
Medical device
How many people
34 participants
Where
1 siteUnited States
Study dates
Aug 2000to Dec 2012
Phase
Phase 2
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

  • ≥ 18 years old
  • Informed consent understood and signed
  • Will comply with post-treatment follow-up requirements
  • Candidate for conventional open surgical repair
  • Anatomic Inclusion Criteria:
  • Aneurysm is ≥ 4.0 cm in outer diameter or Saccular aneurysm ≥ 3.0 cm in outer diameter or Aneurysm ≥ twice the normal aortic outer diameter or rapidly growing aneurysm (≥ 5 mm over 6 months)

Who cannot join

  • Life expectancy < 2 years
  • Participating in another clincal research study
  • Pregnant or lactating women
  • Acutely ruptured or leaking aneurysm, or vascular injury due to trauma
  • Patient has other medical or psychiatric problems, which in the opinion of the Investigator, precludes them from participating in the Study.
  • Contrast medium or anticoagulation drugs are contraindicated
Show all 12Show fewer
  • Coagulopathy or bleeding disorder
  • Active systemic or localized groin infection
  • Inferior mesenteric artery is indispensable
  • Connective tissue disease (e.g. Marfan's Syndrome)
  • Creatinine level > 1.7 mg/dl
  • Thrombus at implantation sites

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Arizona Heart Institute

    Phoenix, Arizona, 85006

Other trials in United States

About this study

Official title: Endologix Bifurcated PowerLink System Clinical Study

The Bifurcated PowerLink System is intended to provide a permanent alternative conduit for blood flow within a patient's abdominal vascular system, which excludes the aneurysmal sac from blood flow and pressure.

Read the detailed description

An arterial anuerysm is a permanent, localized dilatation of an artery with an increase in diameter ≥ 50% larger than the normal artery. Although any artery may develop an aneurysm, they are most commonly seen in the abdominal aorta, the thoracic aorta, the popliteal artery and the common iliac artery.

The use of intravascular stents and endoluminal grafts to exclude natural arterial aneurysms or treat occlusive vascular lesions has been evaluated in a number of preclinical studies. Endovascular stent graft implantation obviates the need for abdominal surgery by using the peripheral arteries as a route to the aneurysm, and stents provide a means of graft attachment other than sutures. The goal of endoluminal grafting is the same as that of conventional repair and allows insertion of a resilient conduit between the ends of the aneurysm to exclude it from the circulation and prevent rupture of the aneurysm.

This is a Phase 2 Clinical Study of the Bifurcated PowerLink System (Endoluminal Graft) for the treatment of abdominal infrarenal aorto-iliac aneurysmal disease (AAA). Diagnostic imaging methods such as Spiral CT Scans, angiography, ultrasound and fluoroscopy imaging will be used to choose the sites for placement of the device and to assure precise deployment.

The Delivery Catheter allows endovascular placement of the Device (endoluminal graft) via either retrograde (femoral or iliac arteries) or antegrade (brachial arteries) approaches. The Endoluminal Graft (ELG) is a self-expanding metal alloy stent cage, which is covered on the outside by a thin walled ePTPE graft material. The graft material is fully supported throughout the entire ELG length. The ELG is also available in a bifurcated configuration. The bifurcated delivery catheter is available in various diameters and working lengths. The catheter consists of an introducer sheath with homeostatic vavle and an inner shaft. The inner shaft is an obturator with a tapered tip connected to a rear obturator by means of a hypotube. The main body of the ELG is compressed around the hypotube then loaded into the Delivery Catheter. The contralateral and ipsilateral limbs of the ELG are compressed in their respective limb covers and loaded into the Delivery Catheter. The inner shaft accommodates a standard .035 inch guidewire.

The concurrent surgical control and test patients' participation in the Study will include enrollment, the Investigational Device procedure or surgical repair and follow-up period. Patient data will be collected during: pre-operative, operative and post-operative follow-up at discharge and at 1 month. Long term follow-up for both the concurrent surgical controls and test patients will continue for 6 and 12 months to support a PMA. Extended follow-up may be required until the Investigational Device is approved under a PMA, or up to 5 years follow-up under Post Market Surveillance requirements.

Conditions
Aortic Aneurysm
Being tested
Endoluminal Graft
Keywords
Abdominal Infrarenal Aortic, Aorto-Iliac Aneurysms
Medical subject headings
Aortic Aneurysm

What participants receive

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

  • Endoluminal GraftDevice

What is being measured

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

  1. Mortality Rate

    Measured: one year

  2. Major complications: myocardial infarction, coronary intervention, respiratory failure, aneurysm rupture, kidney failure, stroke or death

    Measured: one year

Secondary outcomes (7)

  1. Delivery and stent graft deployment success

    Measured: 1 month, 6 month, and 12 months

  2. Apposition to the vessel wall

    Measured: 1 month, 6 month, and 12 months

  3. Device Integrity

    Measured: 1 month, 6 month, and 12 months

  4. Stent graft patency, occlusion (non-patency) and migration

    Measured: 1 month, 6 month, and 12 months

  5. Duration of surgical procedure and hospitalization

    Measured: 1 month, 6 month, and 12 months

  6. Time spent in the ICU

    Measured: 1 month, 6 month, and 12 months

  7. Amount of blood loss and number of patients requiring blood transfusion with stored blood

    Measured: 1 month, 6 month, and 12 months

Timeline

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

  1. First posted25 Oct 2007 (estimated)
  2. Study startAug 2000
  3. Study completionDec 2012 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00549354
Sponsor's protocol ID
00-005
Status last verified
Oct 2007
First submitted
24 Oct 2007
Last updated
3 Jun 2015
Results posted
No
Data monitoring committee
No

Publications

  • Bickerstaff LK, Hollier LH, Van Peenen HJ, Melton LJ 3rd, Pairolero PC, Cherry KJ. Abdominal aortic aneurysms: the changing natural history. J Vasc Surg. 1984 Jan;1(1):6-12.

    PubMed 6481873

  • Castleden WM, Mercer JC. Abdominal aortic aneurysms in Western Australia: descriptive epidemiology and patterns of rupture. Br J Surg. 1985 Feb;72(2):109-12. doi: 10.1002/bjs.1800720213.

    PubMed 3971115

  • Lilienfeld DE, Gunderson PD, Sprafka JM, Vargas C. Epidemiology of aortic aneurysms: I. Mortality trends in the United States, 1951 to 1981. Arteriosclerosis. 1987 Nov-Dec;7(6):637-43. doi: 10.1161/01.atv.7.6.637.

    PubMed 3689207

  • Bickerstaff LK, Pairolero PC, Hollier LH, Melton LJ, Van Peenen HJ, Cherry KJ, Joyce JW, Lie JT. Thoracic aortic aneurysms: a population-based study. Surgery. 1982 Dec;92(6):1103-8.

    PubMed 7147188

  • McFarlane MJ. The epidemiologic necropsy for abdominal aortic aneurysm. JAMA. 1991 Apr 24;265(16):2085-8.

    PubMed 2013928

  • Collin J, Araujo L, Walton J. How fast do very small abdominal aortic aneurysms grow? Eur J Vasc Surg. 1989 Feb;3(1):15-7. doi: 10.1016/s0950-821x(89)80102-1.

    PubMed 2714450

  • Bernstein EF, Chan EL. Abdominal aortic aneurysm in high-risk patients. Outcome of selective management based on size and expansion rate. Ann Surg. 1984 Sep;200(3):255-63. doi: 10.1097/00000658-198409000-00003.

    PubMed 6465980

  • Delin A, Ohlsen H, Swedenborg J. Growth rate of abdominal aortic aneurysms as measured by computed tomography. Br J Surg. 1985 Jul;72(7):530-2. doi: 10.1002/bjs.1800720709.

    PubMed 4016532

  • Cronenwett JL, Murphy TF, Zelenock GB, Whitehouse WM Jr, Lindenauer SM, Graham LM, Quint LE, Silver TM, Stanley JC. Actuarial analysis of variables associated with rupture of small abdominal aortic aneurysms. Surgery. 1985 Sep;98(3):472-83.

    PubMed 3898453

  • Brown PM, Pattenden R, Gutelius JR. The selective management of small abdominal aortic aneurysms: the Kingston study. J Vasc Surg. 1992 Jan;15(1):21-5; discussion 25-7. doi: 10.1067/mva.1992.33840.

    PubMed 1728677

  • Guirguis EM, Barber GG. The natural history of abdominal aortic aneurysms. Am J Surg. 1991 Nov;162(5):481-3. doi: 10.1016/0002-9610(91)90266-g.

    PubMed 1951914

  • Ouriel K, Green RM, Donayre C, Shortell CK, Elliott J, DeWeese JA. An evaluation of new methods of expressing aortic aneurysm size: relationship to rupture. J Vasc Surg. 1992 Jan;15(1):12-8; discussion 19-20. doi: 10.1067/mva.1992.32982.

    PubMed 1728670

  • Limet R, Sakalihassan N, Albert A. Determination of the expansion rate and incidence of rupture of abdominal aortic aneurysms. J Vasc Surg. 1991 Oct;14(4):540-8. doi: 10.1067/mva.1991.30047.

    PubMed 1920652

  • Nevitt MP, Ballard DJ, Hallett JW Jr. Prognosis of abdominal aortic aneurysms. A population-based study. N Engl J Med. 1989 Oct 12;321(15):1009-14. doi: 10.1056/NEJM198910123211504.

    PubMed 2674715

  • Ingoldby CJ, Wujanto R, Mitchell JE. Impact of vascular surgery on community mortality from ruptured aortic aneurysms. Br J Surg. 1986 Jul;73(7):551-3. doi: 10.1002/bjs.1800730711.

    PubMed 3730787

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Endoluminal Graft in people with Aortic Aneurysm, run by Arizona Heart Institute at 1 site 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 6 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 3 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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?

Mortality Rate (time frame: one 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 NCT00549354, which also lists 51 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 3 Jun 2015.

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