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Abdominal Aortic/Aorto-Iliac Aneurysm Endoluminal Graft Study

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2007 by Arizona Heart Institute.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00549354
First Posted: October 25, 2007
Last Update Posted: June 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Endologix
Information provided by:
Arizona Heart Institute
  Purpose
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.

Condition Intervention Phase
Aortic Aneurysm Device: Endoluminal Graft Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endologix Bifurcated PowerLink System Clinical Study

Resource links provided by NLM:


Further study details as provided by Arizona Heart Institute:

Primary Outcome Measures:
  • Mortality Rate [ Time Frame: one year ]
  • Major complications: myocardial infarction, coronary intervention, respiratory failure, aneurysm rupture, kidney failure, stroke or death [ Time Frame: one year ]

Secondary Outcome Measures:
  • Delivery and stent graft deployment success [ Time Frame: 1 month, 6 month, and 12 months ]
  • Apposition to the vessel wall [ Time Frame: 1 month, 6 month, and 12 months ]
  • Device Integrity [ Time Frame: 1 month, 6 month, and 12 months ]
  • Stent graft patency, occlusion (non-patency) and migration [ Time Frame: 1 month, 6 month, and 12 months ]
  • Duration of surgical procedure and hospitalization [ Time Frame: 1 month, 6 month, and 12 months ]
  • Time spent in the ICU [ Time Frame: 1 month, 6 month, and 12 months ]
  • Amount of blood loss and number of patients requiring blood transfusion with stored blood [ Time Frame: 1 month, 6 month, and 12 months ]

Enrollment: 34
Study Start Date: August 2000
Estimated Study Completion Date: December 2012
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥ 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)

Exclusion Criteria:

  • 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
  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00549354


Locations
United States, Arizona
Arizona Heart Institute
Phoenix, Arizona, United States, 85006
Sponsors and Collaborators
Arizona Heart Institute
Endologix
Investigators
Principal Investigator: Edward B Diethrich, M.D. Arizona Heart Institute
  More Information

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Maass D, Zollikofer CL, Largiadèr F, Senning A. Radiological follow-up of transluminally inserted vascular endoprostheses: an experimental study using expanding spirals. Radiology. 1984 Sep;152(3):659-63.
Balko A, Piasecki GJ, Shah DM, Carney WI, Hopkins RW, Jackson BT. Transfemoral placement of intraluminal polyurethane prosthesis for abdominal aortic aneurysm. J Surg Res. 1986 Apr;40(4):305-9.
Lawrence DD Jr, Charnsangavej C, Wright KC, Gianturco C, Wallace S. Percutaneous endovascular graft: experimental evaluation. Radiology. 1987 May;163(2):357-60.
Palmaz JC, Sibbitt RR, Tio FO, Reuter SR, Peters JE, Garcia F. Expandable intraluminal vascular graft: a feasibility study. Surgery. 1986 Feb;99(2):199-205.
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Yoshioka T, Wright KC, Wallace S, Lawrence DD Jr, Gianturco C. Self-expanding endovascular graft: an experimental study in dogs. AJR Am J Roentgenol. 1988 Oct;151(4):673-6.
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Chuter TA, Green RM, Ouriel K, Fiore WM, DeWeese JA. Transfemoral endovascular aortic graft placement. J Vasc Surg. 1993 Aug;18(2):185-95; discussion 195-7.
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Moore W. Presented the Southern California Chapter of the American College of Surgeons Meeting, Newport Beach, CA. January 1994.
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May J, White GH. Presented at III International Endovascular Surgery Symposium, Sydney, Australia, November 1993 and VII International Congress on Endovascular Interventions, Phoenix, Arizona, February 1994.
Chuter T. Presented at III International Endovascular Surgery Symposium, Sydney, Australia, November 1993 and VII International Congress on Endovascular Interventions, Phoenix, Arizona, February 1994.
Marin ML. Stented grafts for the treatment of aorto-iliac and femoropopliteal occlusive disease. Abstract, VII International Congress on Endovascular Interventions, Phoenix, Arizona, February 1994.
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ClinicalTrials.gov Identifier: NCT00549354     History of Changes
Other Study ID Numbers: 00-005
First Submitted: October 24, 2007
First Posted: October 25, 2007
Last Update Posted: June 3, 2015
Last Verified: October 2007

Keywords provided by Arizona Heart Institute:
Abdominal Infrarenal Aortic
Aorto-Iliac Aneurysms

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Iliac Aneurysm
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases


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