VALOR: The Talent Thoracic Stent Graft System Clinical Study

Thoracic Aortic Aneurysms Clinical Trial

— VALOR  

Official title:

Evaluation of the Medtronic Vascular Talent Thoracic Stent Graft System for the Treatment of Thoracic Aortic Aneurysms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00604799
• Other study ID #: Investigational Plan #031
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: July 2003
• Est. completion date: June 2011

Study information

• Verified date: October 2021
• Source: Medtronic Cardiovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Descending Thoracic Aneurysm is a bulge in the aorta. The aorta is a large blood vessel that carries blood away from your heart to organs in the rest of your body. Your aneurysm is caused by a weakening in the artery wall. If left untreated, this bulge may continue to grow larger and may ultimately rupture (break open) or extend in size to seriously affect other major arteries in the area. In this Research Study a device will be placed inside your aorta to block the weakened part of the artery wall from the circulatory system. Information will be collected on the performance for the device for 5 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 379
• Est. completion date: June 2011
• Est. primary completion date: June 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Talent Captivia Inclusion Criteria

1. Patient is at least 18 years of age.

2. Patient is a surgical or non-surgical candidate

3. Patient has a:

1. Fusiform focal TAA AND / OR

2. Focal saccular TAA or penetrating atherosclerotic ulcer.

4. Subject's anatomy must meet all of the following anatomical criteria:

1. iliac/femoral access vessel morphology that is compatible with vascular access techniques, devices, and/or accessories

2. non-aneurysmal aortic diameter in the range of 18-42mm; and

3. non-aneurysmal aortic proximal and distal neck lengths =/>20mm

5. Thoracic aortic lesion is confirmed, at a minimum, by diagnostic contrast enhanced computerized tomography (CTA) with optional 3-D reconstruction, and/or contrast enhanced Magnetic Resonance Angiogram (MRA) obtained within the previous three (3) months prior to the implant procedure.

6. Subject or subject's legal representative understands and has signed an Informed Consent approved by the Sponsor and by the IRB for this study.

7. Patient must be able and willing to undergo follow-up imaging and examinations postoperatively up to 6 months.

Talent Captivia Exclusion Criteria

1. Planned placement of the COVERED (top edge of fabric) portion of the stent graft requires implant to occur in zones 0 or 1

2. Pregnant female

3. Patient has a connective tissue disease (e.g Marfan's syndrome, medial degeneration).

4. Patient has a mycotic aneurysm or is suspected of having systemic infection.

5. Patient has a history of bleeding diathesis, coagulopathy, or refuses blood transfusions.

6. Patient is currently participating in an investigational drug or device clinical trial that would interfere with the Talent Captivia protocol endpoints or follow-up.

7. The patient has known allergy or intolerance to the device components.

8. The patient has a known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment.

9. The patient has another medical condition, which may cause them to be non-compliant with the protocol, confound the data interpretation, or limited life expectancy of less than 6 months.

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Thoracic
• Thoracic Aortic Aneurysms

Intervention

Device:
• Talent Thoracic Stent Graft
TEVAR

Locations

Country	Name	City	State
United States	University of Pennsylvania Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiovascular

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Efficacy Endpoint: proportion of patients in the Test Group who have successful aneurysm treatment at the 12-month follow-up visit.		12 months
Primary	Primary Safety Endpoint: rate of "all cause" mortality of TAA repair with the Talent Thoracic Stent Graft against the literature control for open surgical repair within 1 year of follow-up.		12 months