Clinical Trial: Abdominal Aortic/Aorto-Iliac Aneurysm Endoluminal Graft Study

Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Endologix Bifurcated PowerLink System Clinical Study

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.

Detailed Summary:

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 diamet
Sponsor: Arizona Heart Institute

Current Primary Outcome:

  • 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 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Arizona Heart Institute

Dates:
Date Received: October 24, 2007
Date Started: August 2000
Date Completion: December 2012
Last Updated: June 2, 2015
Last Verified: October 2007