Abdominal Aortic/Aorto-Iliac Aneurysm Endoluminal Graft Study

June 2, 2015 updated by: Arizona Heart Institute

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Arizona Heart Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mortality Rate
Time Frame: one year
one year
Major complications: myocardial infarction, coronary intervention, respiratory failure, aneurysm rupture, kidney failure, stroke or death
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Delivery and stent graft deployment success
Time Frame: 1 month, 6 month, and 12 months
1 month, 6 month, and 12 months
Apposition to the vessel wall
Time Frame: 1 month, 6 month, and 12 months
1 month, 6 month, and 12 months
Device Integrity
Time Frame: 1 month, 6 month, and 12 months
1 month, 6 month, and 12 months
Stent graft patency, occlusion (non-patency) and migration
Time Frame: 1 month, 6 month, and 12 months
1 month, 6 month, and 12 months
Duration of surgical procedure and hospitalization
Time Frame: 1 month, 6 month, and 12 months
1 month, 6 month, and 12 months
Time spent in the ICU
Time Frame: 1 month, 6 month, and 12 months
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
1 month, 6 month, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2000

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

October 24, 2007

First Submitted That Met QC Criteria

October 24, 2007

First Posted (Estimate)

October 25, 2007

Study Record Updates

Last Update Posted (Estimate)

June 3, 2015

Last Update Submitted That Met QC Criteria

June 2, 2015

Last Verified

October 1, 2007

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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