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OpenTrials
Completed

NCT Number: NCT00803075

Endovascular Repair of Abdominal Aortic Aneurysms

The purpose of this study is to determine if it is safe and effective to use the TALENT AAA Stent Graft System as a treatment for AAAs in patients who are also candidates for conventional surgical aneurysm repair.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

1. Patient has one of the following:

  • Aneurysm >4 cm in diameter, or an aneurysm that has increased in size by 0.5 cm in the last 6-months
  • Aneurysm is 1.5 times larger than the diameter of the normal infrarenal aorta or symptomatic
  • Aneurysm is saccular
  • Penetrating ulcer 2. Patient's vascular dimensions must be in the range that can be safely treated with the stent graft available to the physician at the time of the procedure.
  • Patient has endovascular access to the aneurysmal site with the Introducer Sheath or Delivery Catheter of the appropriate ize device chosen for treatment.
  • Patient has anatomic characteristics suitable for endovascular repair. 5. Patient has an immediate life-threatening disease of the abdominal aorta in which there is a reasonable likelihood that death will occur within a matter of months or in which premature death is likely without early treatment.
  • Patient is American Society of Anesthesiology (ASA) grade 1 through 4. 7. Patient is able and willing to comply with 3 month, 6 month, 1 year and every year thereafter post treatment follow-up requirements.
  • Patient or patient's legal representative understands and has signed an Informed Consent.
 Exclusion Criteria:1. Patient is pregnant or nursing. 2. Patient is morbidly obese or has other clinical conditions that severely inhibit X-ray visualization of the aorta.
  • Patient has connective disease. 4. Patient is hypercoagulable. 5. Patient has active systemic infection. 6. Patient is less than 18 years old. 7. Patient has less than a one-year life expectancy. 8. Patient is unwilling or unable to return for follow-up visits.

Treatment and study plan

Endovascular Repair of Abdominal Aortic Aneurysms Using TALENT AAA Stent Graft System

Device

Primary outcomes

  1. Delivery success

  2. Deployment success

  3. Stent graft migration

  4. Aneurysm exclusion

  5. Stent graft patency

  6. Device integrity

  7. Major morbidity and mortality

  8. Vessel perforation

  9. Stent graft occlusion

  10. Collateral vessel occlusion

  11. Aneurysm rupture

Secondary outcomes

  1. Technical success

  2. Patency

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

TALENT Endoluminal Stent Graft System for the Treatment of Abdominal Aortic Aneurysms

Important dates

Study start
2002
Primary completion
2005
Study completion
2005
First posted
Dec 5, 2008
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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