NCT00549315

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

October 24, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 25, 2007

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

May 15, 2009

Status Verified

May 1, 2009

Enrollment Period

9.9 years

First QC Date

October 24, 2007

Last Update Submit

May 14, 2009

Conditions

Thoracic Aortic Aneurysm

Outcome Measures

Primary Outcomes (1)

  • Determine the proportion in whom successful implantation is achieved, as indicated by aneurysm exclusion and graft patency.

    At implant, time of discharge, and 1, 6, and 12 months.

Secondary Outcomes (2)

  • Determine the proportion of patients who experience adverse events.

    During and after implantation.

  • Determine the proportion of patients who experience comorbidities and overall mortality rates.

    During and after implantation.

Study Arms (1)

1

EXPERIMENTAL
Device: Valiant Endoluminal Stent-Graft Stent-Graft Balloon Catheter

Interventions

Valiant Endoluminal Stent-Graft Stent-Graft Balloon CatheterDEVICE

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.

1

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Subject has TAA with less than 10 mm proximal fixation length.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arizona Heart Institute

Phoenix, Arizona, 85006, United States

RECRUITING

Related Publications (10)

  • Coselli JS, S Buket, and ES Crawford. 1996. Thoracic aortic aneurysms. In: Haimovicis Vascular Surgery, 4th ed, H Haimovici, E Ascer, LH Hollier, DE Strandness, and JB Towne, eds. Blackwell Science, chapter 57.

    BACKGROUND

  • Coselli JS and SA LeMaire. 1995. Diseases of the thoracic aorta. In: Current Diagnosis and Treatment in Vascular Surgery, 1st ed, RH Dean, JST Yao, and DC Brewster, eds. Appleton & Lange, Norwalk, CT, chapter 11.

    BACKGROUND

  • Dake MD, Miller DC, Semba CP, Mitchell RS, Walker PJ, Liddell RP. Transluminal placement of endovascular stent-grafts for the treatment of descending thoracic aortic aneurysms. N Engl J Med. 1994 Dec 29;331(26):1729-34. doi: 10.1056/NEJM199412293312601.

    PMID: 7984192BACKGROUND

  • Mitchell RS, Miller DC, Dake MD. Stent-graft repair of thoracic aortic aneurysms. Semin Vasc Surg. 1997 Dec;10(4):257-71.

    PMID: 9431597BACKGROUND

  • Moreno-Cabral CE, Miller DC, Mitchell RS, Stinson EB, Oyer PE, Jamieson SW, Shumway NE. Degenerative and atherosclerotic aneurysms of the thoracic aorta. Determinants of early and late surgical outcome. J Thorac Cardiovasc Surg. 1984 Dec;88(6):1020-32.

    PMID: 6503314BACKGROUND

  • Najafi H. Thoracic aortic aneurysm: evaluation and surgical management. Compr Ther. 1994;20(5):282-8. No abstract available.

    PMID: 8045085BACKGROUND

  • Pressler V, McNamara JJ. Thoracic aortic aneurysm: natural history and treatment. J Thorac Cardiovasc Surg. 1980 Apr;79(4):489-98. No abstract available.

    PMID: 7359927BACKGROUND

  • Skeens JL and MD Dake. 1997. Thoracic aortic aneurysm stent-grafts. Eighth Complex Peripheral Angioplasty Course. Paris, May 20-23, 1997, pp. 289-295.

    BACKGROUND

  • Nienaber CA, Fattori R, Lund G, Dieckmann C, Wolf W, von Kodolitsch Y, Nicolas V, Pierangeli A. Nonsurgical reconstruction of thoracic aortic dissection by stent-graft placement. N Engl J Med. 1999 May 20;340(20):1539-45. doi: 10.1056/NEJM199905203402003.

    PMID: 10332015BACKGROUND

  • White RA, Donayre CE, Walot I, Lippmann M, Woody J, Lee J, Kim N, Kopchok GE, Fogarty TJ. Endovascular exclusion of descending thoracic aortic aneurysms and chronic dissections: Initial clinical results with the AneuRx device. J Vasc Surg. 2001 May;33(5):927-34. doi: 10.1067/mva.2001.114998.

    PMID: 11331830BACKGROUND

MeSH Terms

Conditions

Aortic Aneurysm, Thoracic

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Officials

  • Edward B Diethrich, M.D.

    Arizona Heart Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Russell Williams

CONTACT

602-266-2200rwilliams@azheart.com

Anthony Forner

CONTACT

602-266-2200tforner@azheart.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 24, 2007

First Posted

October 25, 2007

Study Start

October 1, 2002

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

May 15, 2009

Record last verified: 2009-05

Locations

US(1)