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VALOR: The Talent Thoracic Stent Graft System Clinical Study (VALOR)

Primary Purpose

Thoracic Aortic Aneurysms

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Talent Thoracic Stent Graft

About this trial

This is an interventional treatment trial for Thoracic Aortic Aneurysms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Talent Captivia Inclusion Criteria

Patient is at least 18 years of age.
Patient is a surgical or non-surgical candidate
Patient has a:
1. Fusiform focal TAA AND / OR
2. Focal saccular TAA or penetrating atherosclerotic ulcer.
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
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.
Subject or subject's legal representative understands and has signed an Informed Consent approved by the Sponsor and by the IRB for this study.
Patient must be able and willing to undergo follow-up imaging and examinations postoperatively up to 6 months.

Talent Captivia Exclusion Criteria

Planned placement of the COVERED (top edge of fabric) portion of the stent graft requires implant to occur in zones 0 or 1
Pregnant female
Patient has a connective tissue disease (e.g Marfan's syndrome, medial degeneration).
Patient has a mycotic aneurysm or is suspected of having systemic infection.
Patient has a history of bleeding diathesis, coagulopathy, or refuses blood transfusions.
Patient is currently participating in an investigational drug or device clinical trial that would interfere with the Talent Captivia protocol endpoints or follow-up.
The patient has known allergy or intolerance to the device components.
The patient has a known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment.
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.

Sites / Locations

University of Pennsylvania Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Other

Arm Label

Test (Enrollment Completed)

Registry (Enrollment Completed)

High Risk (Enrollment Completed)

Talent Captivia (Recruiting)

Arm Description

Patients diagnosed with a TAA of degenerative etiology that are considered candidates for open surgical repair whom are low to moderate risk (0, 1, & 2) per the modified SVS/AAVS criteria who meet inclusion/exclusion criteria. The aneurysm must be at least 20 mm distal to the left common carotid artery & 20 mm proximal to the origin of the celiac artery.

Surgical candidates of low to moderate risk (SVS 0, 1, 2) that meet the Registry Inclusion/Exclusion criteria.

Patients that meet one or more of the following: High Risk (SVS 3) Non-surgical candidates not associated with SVS scoring Traumatic thoracic injuries

Patients diagnosed with a TAA of degenerative etiology that are considered candidates for open surgical repair who meet inclusion/exclusion criteria.

Outcomes

Primary Outcome Measures

Primary Efficacy Endpoint: proportion of patients in the Test Group who have successful aneurysm treatment at the 12-month follow-up visit.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00604799

First Posted

December 21, 2007

Last Updated

October 27, 2021

Sponsor

Medtronic Cardiovascular

1. Study Identification

Unique Protocol Identification Number

NCT00604799

Brief Title

VALOR: The Talent Thoracic Stent Graft System Clinical Study

Acronym

VALOR

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

July 2003 (undefined)

Primary Completion Date

June 2006 (Actual)

Study Completion Date

June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medtronic Cardiovascular

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Thoracic Aortic Aneurysms

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

379 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Test (Enrollment Completed)

Arm Type

Active Comparator

Arm Description

Arm Title

Registry (Enrollment Completed)

Arm Type

Other

Arm Description

Surgical candidates of low to moderate risk (SVS 0, 1, 2) that meet the Registry Inclusion/Exclusion criteria.

Arm Title

High Risk (Enrollment Completed)

Arm Type

Other

Arm Description

Patients that meet one or more of the following: High Risk (SVS 3) Non-surgical candidates not associated with SVS scoring Traumatic thoracic injuries

Arm Title

Talent Captivia (Recruiting)

Arm Type

Other

Arm Description

Patients diagnosed with a TAA of degenerative etiology that are considered candidates for open surgical repair who meet inclusion/exclusion criteria.

Intervention Type

Device

Intervention Name(s)

Talent Thoracic Stent Graft

Intervention Description

TEVAR

Primary Outcome Measure Information:

Title

Primary Efficacy Endpoint: proportion of patients in the Test Group who have successful aneurysm treatment at the 12-month follow-up visit.

Time Frame

12 months

Title

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.

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Talent Captivia Inclusion Criteria Patient is at least 18 years of age. Patient is a surgical or non-surgical candidate Patient has a: Fusiform focal TAA AND / OR Focal saccular TAA or penetrating atherosclerotic ulcer. Subject's anatomy must meet all of the following anatomical criteria: iliac/femoral access vessel morphology that is compatible with vascular access techniques, devices, and/or accessories non-aneurysmal aortic diameter in the range of 18-42mm; and non-aneurysmal aortic proximal and distal neck lengths =/>20mm 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. Subject or subject's legal representative understands and has signed an Informed Consent approved by the Sponsor and by the IRB for this study. Patient must be able and willing to undergo follow-up imaging and examinations postoperatively up to 6 months. Talent Captivia Exclusion Criteria Planned placement of the COVERED (top edge of fabric) portion of the stent graft requires implant to occur in zones 0 or 1 Pregnant female Patient has a connective tissue disease (e.g Marfan's syndrome, medial degeneration). Patient has a mycotic aneurysm or is suspected of having systemic infection. Patient has a history of bleeding diathesis, coagulopathy, or refuses blood transfusions. Patient is currently participating in an investigational drug or device clinical trial that would interfere with the Talent Captivia protocol endpoints or follow-up. The patient has known allergy or intolerance to the device components. The patient has a known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment. 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.

Overall Study Officials: