Abdominal Aortic/Aorto-Iliac Aneurysm Endoluminal Graft Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by Arizona Heart Institute.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Endologix
Information provided by:
Arizona Heart Institute
ClinicalTrials.gov Identifier:
NCT00549354
First received: October 24, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Publications:
Palmaz JC, Parodi JC, Barone HD, et al. Transluminal bypass of experimental abdominal aortic aneurysm. RSNA 1990; 177(s):202.
Parodi JC. Endovascular repair of abdominal aortic aneurysms. Advances in Vascular Surgery 1993; 1:85-106.
Piquet P, Bartoli JM, Rolland PH, Mercier C. Tantalum Dacron co-knit stent for endovascular treatment of aorto-iliac aneurysms. Presented at the 17th World Congress of the International Union of Angiology, London, England, April 1995.
Moore W. Presented the Southern California Chapter of the American College of Surgeons Meeting, Newport Beach, CA. January 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.
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.
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.
Diethrich EB, Parazoglou CD, Lundquist P, Rodriguez-Lopez J, Lopez-Galarza L, Eckert J, Stone D, Cassess R, Matveevskii A. Early experience with aneurysm exclusion devices and endoluminal bypass prosthesis. Abstract, VII International Congress on Endovascular Interventions, Phoenix, Arizona, February 1994.
Chuter T, Hopinson B, Wendt G et al. Transfemoral aortic aneurysm repair with bifurcated endovascular grafts. Presented at the 43rd meeting of the International Society for Cardiovascular surgery, North American Chapter, New Orleans, LA June 1995.
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.

ClinicalTrials.gov Identifier: NCT00549354     History of Changes
Other Study ID Numbers: 00-005
Study First Received: October 24, 2007
Last Updated: October 24, 2007
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 20, 2014