Recruiting

Observational Study

Sponsor:

Arizona Heart Institute

Code:

NCT00549315

Conditions

Thoracic Aortic Aneurysm

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Valiant Endoluminal Stent-Graft Stent-Graft Balloon Catheter

Study Details

Brief summary:

The Valiant stent-graft system is a flexible, implantable vascular stent-graft endoluminal device preloaded in a delivery system that is used to exclude thoracic aortic lesions (thoracic aneurysms, thoracic dissections, penetrating ulcers, traumatic transections and both traumatic and degenerative pseudoaneurysms.

Conditions

Thoracic Aortic Aneurysm

Study ID

NCT00549315

Start date

Oct, 2002

Status verified date

May, 2009

Completion date

Sep, 2012

Anticipated

Primary completion date

Sep, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Subject is ≥ 18 years of age.
  • Subject is not pregnant or lactating. Females of child-bearing potential must practice a reliable method of contraception.
  • Subject is diagnosed with one of the following conditions of the descending thoracic aorta. All conditions must be verified by diagnostic imaging \[ultrasonography, computed tomography (CT), magnetic resonance imaging (MRI) or angiography\].

  • A true (i.e., atherosclerotic) supraceliac aneurysm (fusiform or saccular type) with or without a co-existing aortic dissection or penetrating aortic ulcer;
  • Aortic dissection of DeBakey Type I or II (Stanford A, proximal) in the absence of an aneurysm; or
  • Penetrating aortic ulcer in the absence of an aneurysm; or
  • Traumatic transection; or
  • Pseudoaneurysm - traumatic or degenerative (i.e., one that does not involve all layers of the vessel and is not atherosclerotic in origin.
  • Subject's anatomy is suitable for placement of the TALENT endoluminal stent-graft, with a distinct proximal aneurysm neck of 10 mm or more in length and a distal aneurysm neck of at least 10 mm.
  • Subject has a TAA that is dilated to ≥ 5 cm in diameter, ≥ 1.5 times the diameter of the adjacent native/non-aneurysmal aorta, or is symptomatic.
  • Subject has a proximal and distal aortic neck diameter ≥ 18 mm and ≤ 42 mm.
  • Subject has an arterial access site, either peripherally or via infrarenal abdominal aorta that is adequate for introduction of the stent-graft delivery system.
  • Subject has signed the informed consent.
  • Subject will be available for the periodic follow-up (surveillance) after the procedure.
  • Aortic.

Exclusion Criteria:

  • Subject has TAA with less than 10 mm proximal fixation length.
  • Subject has an aneurysm that would require exclusion by the stent-graft of the segment of the aorta that gives rise to dominant spinal cord/intercostal arteries.
  • Subject has a lesion that prevents delivery or expansion of the device.
  • Subject has systemic infection, or is suspected of having systemic infection.
  • Subject has a known mycotic aneurysm.
  • Subject is not available or is not willing to come back for periodic follow-up (surveillance) after the procedure.

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 1

Interventions

Valiant Endoluminal Stent-Graft Stent-Graft Balloon Catheter

VALIANT stent-graft endoprosthesis is inserted by the Xcelerant Delivery System via a surgical cutdown (e.g., external iliac artery, femoral artery, common iliac artery conduit, etc.) approach. The insertion method depends on each patient's anatomy and is determined by the Clinical Investigator.

Primary outcome measure

  • Determine the proportion in whom successful implantation is achieved, as indicated by aneurysm exclusion and graft patency. [ Time Frame: At implant, time of discharge, and 1, 6, and 12 months. ]

Central Contacts and Locations

Central contacts

Russell Williams

602-266-2200rwilliams@azheart.com

Anthony Forner

602-266-2200tforner@azheart.com

Locations

Arizona Heart Institute

Recruiting

Phoenix, Arizona, United States, 85006

Principal Investigator:

Edward B Diethrich, M.D.

More Information

Sponsor

Arizona Heart Institute

Last update posted

May 15, 2009

Last verified

May, 2009

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Arizona Heart Institute on 2009-05-15.