Abdominal Aortic/Aorto-Iliac Aneurysm Endoluminal Graft Study

NCT00549354 | Unknown Phase 2

• 1 other identifier: 00-005
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aortic Aneurysm

Keywords

Abdominal Infrarenal Aortic; Aorto-Iliac Aneurysms

Outcome Measures

Primary Outcomes (2)

• Mortality Rate

  one year

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

  one year

Secondary Outcomes (7)

• Delivery and stent graft deployment success

  1 month, 6 month, and 12 months

• Apposition to the vessel wall

  1 month, 6 month, and 12 months

• Device Integrity

  1 month, 6 month, and 12 months

• Stent graft patency, occlusion (non-patency) and migration

  1 month, 6 month, and 12 months

• Duration of surgical procedure and hospitalization

  1 month, 6 month, and 12 months

Interventions

Endoluminal Graft DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years old
• Informed consent understood and signed
• Will comply with post-treatment follow-up requirements
• Candidate for conventional open surgical repair
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Arizona Heart Institute: lead
• Endologix: collaborator

Study Sites (1)

Arizona Heart Institute

Phoenix, Arizona, 85006, United States

Location

Related Publications (51)

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  BACKGROUND

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  BACKGROUND

• Parodi J. Presented at III International Endovascular Surgery Symposium, Sydney, Australia, November 1993 and VII International Congress on Endovascular Interventions, Phoenix, Arizona, February 1994.

  BACKGROUND

• Moore W. Presented the Southern California Chapter of the American College of Surgeons Meeting, Newport Beach, CA. January 1994.

  BACKGROUND

• Ahn R. Presented at VII International Congress on Endovascular Interventions, Phoenix, Arizona, February 1994.

  BACKGROUND

• 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.

  BACKGROUND

• Chuter T. Presented at III International Endovascular Surgery Symposium, Sydney, Australia, November 1993 and VII International Congress on Endovascular Interventions, Phoenix, Arizona, February 1994.

  BACKGROUND

• 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.

  BACKGROUND

• Vieth FJ, Mann ML, Panetta TF, Parodi JC, Cinaron J. Stented grafts for the treatment of traumatic arterial lesions and non-aortic aneurysms. Abstract, VII International Congress on Endovascular Interventions, Phoenix, Arizona, February 1994.

  BACKGROUND

• Semba CP, Dake MD, Mitchell RS, Miller DC. Endovascular grafting for the treatment of thoracic aortic aneurysms: Preliminary experience at Stanford University Medical Center. Abstract, VII International Congress on Endovascular Interventions, Phoenix, Arizona, February 1994.

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  BACKGROUND

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  BACKGROUND

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  BACKGROUND

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  BACKGROUND

• Mailhe C. Results of the Stentor Trial. Presented at the 17th World Congress of the International Union of Angiology, London, England, April 1995.

  BACKGROUND

• Mann ML. Complications of endovascular stented grafts for the treatment of arterial lesions: The agony after ecstasy. Presented at the 43rd meeting of the International Society for Cardiovascular Surgery, North American Chapter, New Orleans, LA, June 1994.

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• Ancure Summary of Safety and Efficacy, Table 16, page 18 of 24.

  BACKGROUND

• AneuRx Summary of Safety and Efficacy. Adverse Events, Section 8, Page 7.

  BACKGROUND

MeSH Terms

Conditions

Aortic Aneurysm

Condition Hierarchy (Ancestors)

Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Edward B Diethrich, M.D.

  Arizona Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 24, 2007
• First Posted: October 25, 2007
• Study Start: August 1, 2000
• Study Completion: December 1, 2012
• Last Updated: June 3, 2015

Record last verified: 2007-10

Locations

US (1)