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Valor II: The Valiant Thoracic Stent Graft System Clinical Study

Primary Purpose

Thoracic Aortic Aneurysm

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Valiant Thoracic Stent Graft System
Sponsored by
Medtronic Cardiovascular
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thoracic Aortic Aneurysm focused on measuring Thoracic Aneurysm, Endovascular Aortic Repair (EVAR), Endovascular Stent Graft, Endograft, Thoracic Aortic Aneurysm, Endovascular procedure, Descending Thoracic Aneurysm, Valiant Stent Graft System

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

The following inclusion/exclusion criteria was obtained from the study protocol.

INCLUSION CRITERIA

To be eligible for enrollment, a subject must meet all of the following inclusion criteria:

  1. Subject is between the age of 18 and 85.
  2. Subject must be considered a candidate for elective surgical repair of the TAA (i.e., low-to-moderate risk [categories 0, 1, and 2] per the modified SVS/AAVS scoring system at the time of implant). See Appendix B: Modified SVS/AAVS Medical Co-Morbidity Grading System
  3. If subject is female of childbearing potential, she must have a negative pregnancy test within 7 days before the implant procedure.
  4. Subject has a DTA that is:

    1. A fusiform aneurysm with a maximum diameter of ≥ 5 cm OR is > 2 times the diameter of the non-aneurysmal thoracic aorta;

      AND/OR

    2. Saccular aneurysm (penetrating atherosclerotic ulcer)
  5. Subject's anatomy must meet all of the following anatomical criteria:

    1. Subject's TAA must be ≥ 20 mm distal to the origin of the left common carotid artery and must be ≥ 20 mm proximal to the celiac artery;
    2. Proximal and distal non-aneurysmal neck diameter measurements must be between 20 mm and 42 mm;
    3. Proximal and distal non-aneurysmal neck must be ≥ 20 mm in length.
  6. Thoracic aortic lesion is confirmed, at a minimum, by diagnostic contrast enhanced computerized tomography (CT) with optional 3-D reconstruction, and/or contrast enhanced Magnetic Resonance Angiogram obtained within four (4) months prior to the implant procedure.
  7. Subject is able and willing to comply with the protocol and undergo follow-up requirements.
  8. Subject or subject's legal representative understands and has signed an Informed Consent approved by the Sponsor and by the IRB for this study.
  9. Subject has patent iliac or femoral arteries or can tolerate a vascular conduit that allows endovascular access to the aneurysmal site with the delivery system of the appropriate size device chosen for treatment.

EXCLUSION CRITERIA

To be eligible for enrollment, a subject cannot meet any of the following exclusion criteria:

  1. Planned placement of the COVERED portion of the stent graft requires implant to occur in zones 0 or 1.
  2. Subject has a thoracic aneurysm with a contained rupture.
  3. Subject has a connective tissue disease (e.g., Marfan's syndrome, aortic medial degeneration).
  4. Subject has a mycotic aneurysm or is suspected of having systemic infection.
  5. Subject has received a previous stent or stent graft or previous surgical repair in the DTA.
  6. Subject requires treatment of an infra-renal aneurysm at the time of implant.
  7. Subject has a history of bleeding diathesis, coagulopathy, or refuses blood transfusion.
  8. Subject has had or plans to have a major surgical procedure within 30 days before or after the Valiant Stent Graft procedure. This does not include planned procedures that are needed for the safe and effective placement of the stent graft (i.e., carotid/subclavian transposition, carotid/subclavian bypass procedure).
  9. Subject has had an MI or cerebral vascular accident (CVA) within 3 months.
  10. Subject is currently participating in an investigational drug or device clinical trial.
  11. Subject has a known allergy or intolerance to the device components.
  12. Subject has a known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment.
  13. Subject has significant and/or circumferential aortic mural thrombus at either the proximal or distal attachment sites that would compromise fixation and seal of the device.
  14. Subject has other medical, social, or psychological problems that, in the opinion of the investigator, preclude him or her from receiving this treatment and the procedures and evaluations pre- and post-treatment, or a limited life expectancy of less than 1 year.

Sites / Locations

  • University of Alabama at Birmingham
  • University of Southern California - Healthcare Consultation Center
  • Los Angeles Biomedical Research Institute @ Harbor-UCLA Medical Center
  • Hartford Hospital
  • University of Florida
  • University of South Florida
  • Emory University Hospital
  • Loyola University Medical Center
  • Union Memorial
  • Massachusetts General Hospital
  • William Beaumont Hospital
  • Minneapolis Vascular Physicians
  • Washington University School of Medicine
  • Advance Vascular Associates (Morristown Memorial Hospital)
  • Albany Medical Center
  • New York University Medical Center
  • Mount Sinai School of Medicine
  • University of North Carolina
  • Cleveland Clinic Foundation
  • University of Pennsylvania
  • Shadyside Hospital - University of Pittsburgh Medical Center
  • Baptist Memorial Hospital
  • Baylor College of Medicine
  • St. Luke's Episcopal Hospital - Houston
  • University of Virginia
  • Inova Fairfax Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Valiant Thoracic Stent Graft System

Arm Description

160 subjects were enrolled into the study, including 157 subjects treated with the study device and three subjects classified as intent-to-treat who did not receive the study device. There were no other arms for this study.

Outcomes

Primary Outcome Measures

Percentage of Participants That Did NOT Experience Aneurysm-Related Mortality (Post-market Primary Endpoint)
Evaluation of the ARM-free rate in subjects implanted with the Valiant Thoracic Stent Graft five years post-implantation by comparing it to a pre-defined performance goal (PG) based on an analysis of ARM-free rates from TEVAR data and on results from the VALOR (Talent Thoracic Endoluminal Stent Graft, IDE G980116) clinical study.
Percentage of Participants With Successful Aneurysm Treatment (Primary Effectiveness Endpoint)
Percentage of subjects with absence of both: a) aneurysm growth of more than 5 mm at the 12-month visit relative to the 1-month visit; and b) secondary procedure due to type I or III endoleak performed or recommended at or before the 12-month visit. Success means a subject experienced neither a nor b. Type I: endoleak in continuity with the proximal anchoring site(proximal endoleak) or the distal anchoring site(distal endoleak)of the device. Type III: endoleak is present in the mid-graft region due to defect of fabric or between the segments of the modular graft (junctional endoleak).
Percentage of Participants Who Died (Primary Safety Endpoint: All-Cause Mortality) > >
The percentage of participants who died within 12-months of the initial procedure, whether or not the cause of death was related to the study device, procedure, or condition treated. > > Note: All-cause mortality endpoint is not directly related to successful aneurysm treatment, which pertains to the absence of aneurysm growth and secondary procedure due to Type I and III endoleaks.

Secondary Outcome Measures

Percentage of Subjects That Experienced Successful Deployment and Delivery of the Stent Graft at Implant
Percentage of subjects that experienced successful deployment and delivery of the stent graft at implant. Successful deployment and delivery of the stent graft is used to measure effectiveness.
Percentage of Participants That Experienced Perioperative Mortality
Percentage of subjects that experienced perioperative mortality. Perioperative morality is defined as all-cause mortality within 30 days after index procedure.
Percentage of Participants That Experienced Paraplegia
Percentage of subjects that experienced paraplegia within 30 days post treatment
Percentage of Participants That Experienced Paraparesis
Percentage of subjects that experienced paraparesis within 30 days post treatment
Percentage of Participants That Experienced Secondary Procedures Due to Endoleak After Discharge
Percentage of subjects that experienced secondary procedures due to endoleak after discharge within 30 days post treatment
Percentage of Participants That Experienced One or More Major Adverse Events
Percentage of subjects that experienced one or more major adverse events within 30 days post treatment, regardless of relatedness to study device
Percentage of Participants That Experienced Aneurysm-related Mortality
Percentage of subjects that experienced aneurysm-related mortality within 12 months post treatment
Percentage of Participants That Experience Aneurysm Rupture
Percentage of subjects that experience aneurysm rupture within 12 months post treatment
Percentage of Participants That Experienced Conversion to Open Surgical Repair
Percentage of subjects that experienced conversion to open surgical repair within 12 months post treatment
Percentage of Participants That Experienced Endoleak(s)
Percentage of subjects that experienced endoleak(s) of any type at 12 months
Percentage of Participants That Experienced Secondary Endovascular Procedures Due to Endoleak
Percentage of subjects that experienced secondary endovascular procedures due to endoleak between 30 days and 12 months
Percentage of Participants That Experienced Stent Graft Migration
Percentage of subjects that experienced stent graft migration within 12 months post treatment, as reported by the CEC. Of note, all migrations resulted from anatomical accommodation of the stent graft. All migrations were at the distal end of the stent graft, moving proximally. No endoleaks were associated to these migrations.
Percentage of Participants That Experience Loss of Stent Graft Patency
Percentage of subjects that experience loss of stent graft patency within 12 months post treatment
Percentage of Participants That Experienced One or More Major Adverse Events
Percentage of subjects that experienced one or more Major Adverse Events within 12 months post treatment
Percentage of Participants That Died (All-cause Mortality)
Percentage of subjects that died (all-cause mortality) five years post implant, regardless whether or not the cause of death was related to procedure, device, or condition treated
Percentage of Participants That Experienced Aneurysm-related Mortality
Percentage of subjects that experienced aneurysm-related within five years post implant
Percentage of Participants That Experienced Aneurysm Ruptures
Percentage of subjects that experienced aneurysm ruptures within five years post implant
Percentage of Participants That Experienced Conversions to Open Surgical Repair
Percentage of subjects that experienced conversions to open surgical repair within five years post implant
Percentage of Participants That Experienced Type I Endoleaks
Percentage of subjects that experienced type I endoleaks within five years post implant
Percentage of Participants That Experienced Type III Endoleaks
Percentage of subjects that experienced type III endoleaks within five years post implant
Percentage of Participants That Experienced Type IV Endoleaks
Percentage of subjects that experienced type IV endoleaks within five years post implant
Percentage of Participants That Experienced Secondary Endovascular Procedures
Percentage of subjects that experienced secondary endovascular procedures within five years post implant
Percentage of Participants That Experienced Stent Graft Migrations (Site Reported)
Percentage of subjects that experienced stent graft migrations within five years post implant, as reported by the clinical sites
Percentage of Participants That Experienced Loss of Stent Graft Patency
Percentage of subjects that experienced loss of stent graft patency within five years post implant

Full Information

First Posted
December 15, 2006
Last Updated
October 27, 2021
Sponsor
Medtronic Cardiovascular
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1. Study Identification

Unique Protocol Identification Number
NCT00413231
Brief Title
Valor II: The Valiant Thoracic Stent Graft System Clinical Study
Official Title
The Valiant Thoracic Stent Graft System. The Evaluation of the Clinical Performance of the Valiant Thoracic Stent Graft System in the Treatment of Descending Thoracic Aneurysms of Degenerative Etiology in Subjects Who Are Candidates for Endovascular Repair.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
October 2014 (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
This study was designed to study safety and effectiveness of the Valiant Thoracic Stent Graft to treat thoracic aortic aneurysms.
Detailed Description
The aorta is a large blood vessel that carries blood away from the heart to the organs in the rest of the body. An aneurysm is a weakening in the artery wall that will become a bulge in the aorta. If left untreated, this bulge may continue to grow larger and may rupture (break open) with fatal consequences. In this research study we are investigating a device that can be placed in the aorta to exclude the weakened part of the artery wall and restore blood flow. Information will be collected on the performance of 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 Aneurysm
Keywords
Thoracic Aneurysm, Endovascular Aortic Repair (EVAR), Endovascular Stent Graft, Endograft, Thoracic Aortic Aneurysm, Endovascular procedure, Descending Thoracic Aneurysm, Valiant Stent Graft System

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Valiant Thoracic Stent Graft System
Arm Type
Experimental
Arm Description
160 subjects were enrolled into the study, including 157 subjects treated with the study device and three subjects classified as intent-to-treat who did not receive the study device. There were no other arms for this study.
Intervention Type
Device
Intervention Name(s)
Valiant Thoracic Stent Graft System
Other Intervention Name(s)
Valiant device; Valiant stent graft.
Intervention Description
Surgical procedure in which a device is implanted inside the aorta, isolating the diseased area (aneurysm).
Primary Outcome Measure Information:
Title
Percentage of Participants That Did NOT Experience Aneurysm-Related Mortality (Post-market Primary Endpoint)
Description
Evaluation of the ARM-free rate in subjects implanted with the Valiant Thoracic Stent Graft five years post-implantation by comparing it to a pre-defined performance goal (PG) based on an analysis of ARM-free rates from TEVAR data and on results from the VALOR (Talent Thoracic Endoluminal Stent Graft, IDE G980116) clinical study.
Time Frame
0 through 1825 days post treatment
Title
Percentage of Participants With Successful Aneurysm Treatment (Primary Effectiveness Endpoint)
Description
Percentage of subjects with absence of both: a) aneurysm growth of more than 5 mm at the 12-month visit relative to the 1-month visit; and b) secondary procedure due to type I or III endoleak performed or recommended at or before the 12-month visit. Success means a subject experienced neither a nor b. Type I: endoleak in continuity with the proximal anchoring site(proximal endoleak) or the distal anchoring site(distal endoleak)of the device. Type III: endoleak is present in the mid-graft region due to defect of fabric or between the segments of the modular graft (junctional endoleak).
Time Frame
At 12-month post procedure
Title
Percentage of Participants Who Died (Primary Safety Endpoint: All-Cause Mortality) > >
Description
The percentage of participants who died within 12-months of the initial procedure, whether or not the cause of death was related to the study device, procedure, or condition treated. > > Note: All-cause mortality endpoint is not directly related to successful aneurysm treatment, which pertains to the absence of aneurysm growth and secondary procedure due to Type I and III endoleaks.
Time Frame
Within 12-months post treatment
Secondary Outcome Measure Information:
Title
Percentage of Subjects That Experienced Successful Deployment and Delivery of the Stent Graft at Implant
Description
Percentage of subjects that experienced successful deployment and delivery of the stent graft at implant. Successful deployment and delivery of the stent graft is used to measure effectiveness.
Time Frame
At implant
Title
Percentage of Participants That Experienced Perioperative Mortality
Description
Percentage of subjects that experienced perioperative mortality. Perioperative morality is defined as all-cause mortality within 30 days after index procedure.
Time Frame
Within 30 days post treatment
Title
Percentage of Participants That Experienced Paraplegia
Description
Percentage of subjects that experienced paraplegia within 30 days post treatment
Time Frame
Within 30 days post treatment
Title
Percentage of Participants That Experienced Paraparesis
Description
Percentage of subjects that experienced paraparesis within 30 days post treatment
Time Frame
Within 30 days post treatment
Title
Percentage of Participants That Experienced Secondary Procedures Due to Endoleak After Discharge
Description
Percentage of subjects that experienced secondary procedures due to endoleak after discharge within 30 days post treatment
Time Frame
Within 30 days post treatment
Title
Percentage of Participants That Experienced One or More Major Adverse Events
Description
Percentage of subjects that experienced one or more major adverse events within 30 days post treatment, regardless of relatedness to study device
Time Frame
Within 30 days post treatment
Title
Percentage of Participants That Experienced Aneurysm-related Mortality
Description
Percentage of subjects that experienced aneurysm-related mortality within 12 months post treatment
Time Frame
Within 12 months post treatment
Title
Percentage of Participants That Experience Aneurysm Rupture
Description
Percentage of subjects that experience aneurysm rupture within 12 months post treatment
Time Frame
Within 12 months post treatment
Title
Percentage of Participants That Experienced Conversion to Open Surgical Repair
Description
Percentage of subjects that experienced conversion to open surgical repair within 12 months post treatment
Time Frame
Within 12 months post treatment
Title
Percentage of Participants That Experienced Endoleak(s)
Description
Percentage of subjects that experienced endoleak(s) of any type at 12 months
Time Frame
At 12 months
Title
Percentage of Participants That Experienced Secondary Endovascular Procedures Due to Endoleak
Description
Percentage of subjects that experienced secondary endovascular procedures due to endoleak between 30 days and 12 months
Time Frame
Between 30 days and 12 months
Title
Percentage of Participants That Experienced Stent Graft Migration
Description
Percentage of subjects that experienced stent graft migration within 12 months post treatment, as reported by the CEC. Of note, all migrations resulted from anatomical accommodation of the stent graft. All migrations were at the distal end of the stent graft, moving proximally. No endoleaks were associated to these migrations.
Time Frame
Within 12 months post treatment
Title
Percentage of Participants That Experience Loss of Stent Graft Patency
Description
Percentage of subjects that experience loss of stent graft patency within 12 months post treatment
Time Frame
Within 12 months post treatment
Title
Percentage of Participants That Experienced One or More Major Adverse Events
Description
Percentage of subjects that experienced one or more Major Adverse Events within 12 months post treatment
Time Frame
Within 12 months post treatment
Title
Percentage of Participants That Died (All-cause Mortality)
Description
Percentage of subjects that died (all-cause mortality) five years post implant, regardless whether or not the cause of death was related to procedure, device, or condition treated
Time Frame
0 through 1825 days post treatment
Title
Percentage of Participants That Experienced Aneurysm-related Mortality
Description
Percentage of subjects that experienced aneurysm-related within five years post implant
Time Frame
0 through 1825 days post treatment
Title
Percentage of Participants That Experienced Aneurysm Ruptures
Description
Percentage of subjects that experienced aneurysm ruptures within five years post implant
Time Frame
0 through 1825 days post treatment
Title
Percentage of Participants That Experienced Conversions to Open Surgical Repair
Description
Percentage of subjects that experienced conversions to open surgical repair within five years post implant
Time Frame
0 through 1825 days post treatment
Title
Percentage of Participants That Experienced Type I Endoleaks
Description
Percentage of subjects that experienced type I endoleaks within five years post implant
Time Frame
0 through 1825 days post treatment
Title
Percentage of Participants That Experienced Type III Endoleaks
Description
Percentage of subjects that experienced type III endoleaks within five years post implant
Time Frame
0 through 1825 days post treatment
Title
Percentage of Participants That Experienced Type IV Endoleaks
Description
Percentage of subjects that experienced type IV endoleaks within five years post implant
Time Frame
0 through 1825 days post treatment
Title
Percentage of Participants That Experienced Secondary Endovascular Procedures
Description
Percentage of subjects that experienced secondary endovascular procedures within five years post implant
Time Frame
0 through 1825 days post treatment
Title
Percentage of Participants That Experienced Stent Graft Migrations (Site Reported)
Description
Percentage of subjects that experienced stent graft migrations within five years post implant, as reported by the clinical sites
Time Frame
0 through 1825 days post treatment
Title
Percentage of Participants That Experienced Loss of Stent Graft Patency
Description
Percentage of subjects that experienced loss of stent graft patency within five years post implant
Time Frame
0 through 1825 days post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
The following inclusion/exclusion criteria was obtained from the study protocol. INCLUSION CRITERIA To be eligible for enrollment, a subject must meet all of the following inclusion criteria: Subject is between the age of 18 and 85. Subject must be considered a candidate for elective surgical repair of the TAA (i.e., low-to-moderate risk [categories 0, 1, and 2] per the modified SVS/AAVS scoring system at the time of implant). See Appendix B: Modified SVS/AAVS Medical Co-Morbidity Grading System If subject is female of childbearing potential, she must have a negative pregnancy test within 7 days before the implant procedure. Subject has a DTA that is: A fusiform aneurysm with a maximum diameter of ≥ 5 cm OR is > 2 times the diameter of the non-aneurysmal thoracic aorta; AND/OR Saccular aneurysm (penetrating atherosclerotic ulcer) Subject's anatomy must meet all of the following anatomical criteria: Subject's TAA must be ≥ 20 mm distal to the origin of the left common carotid artery and must be ≥ 20 mm proximal to the celiac artery; Proximal and distal non-aneurysmal neck diameter measurements must be between 20 mm and 42 mm; Proximal and distal non-aneurysmal neck must be ≥ 20 mm in length. Thoracic aortic lesion is confirmed, at a minimum, by diagnostic contrast enhanced computerized tomography (CT) with optional 3-D reconstruction, and/or contrast enhanced Magnetic Resonance Angiogram obtained within four (4) months prior to the implant procedure. Subject is able and willing to comply with the protocol and undergo follow-up requirements. Subject or subject's legal representative understands and has signed an Informed Consent approved by the Sponsor and by the IRB for this study. Subject has patent iliac or femoral arteries or can tolerate a vascular conduit that allows endovascular access to the aneurysmal site with the delivery system of the appropriate size device chosen for treatment. EXCLUSION CRITERIA To be eligible for enrollment, a subject cannot meet any of the following exclusion criteria: Planned placement of the COVERED portion of the stent graft requires implant to occur in zones 0 or 1. Subject has a thoracic aneurysm with a contained rupture. Subject has a connective tissue disease (e.g., Marfan's syndrome, aortic medial degeneration). Subject has a mycotic aneurysm or is suspected of having systemic infection. Subject has received a previous stent or stent graft or previous surgical repair in the DTA. Subject requires treatment of an infra-renal aneurysm at the time of implant. Subject has a history of bleeding diathesis, coagulopathy, or refuses blood transfusion. Subject has had or plans to have a major surgical procedure within 30 days before or after the Valiant Stent Graft procedure. This does not include planned procedures that are needed for the safe and effective placement of the stent graft (i.e., carotid/subclavian transposition, carotid/subclavian bypass procedure). Subject has had an MI or cerebral vascular accident (CVA) within 3 months. Subject is currently participating in an investigational drug or device clinical trial. Subject has a known allergy or intolerance to the device components. Subject has a known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment. Subject has significant and/or circumferential aortic mural thrombus at either the proximal or distal attachment sites that would compromise fixation and seal of the device. Subject has other medical, social, or psychological problems that, in the opinion of the investigator, preclude him or her from receiving this treatment and the procedures and evaluations pre- and post-treatment, or a limited life expectancy of less than 1 year.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald Fairman, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
University of Southern California - Healthcare Consultation Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Los Angeles Biomedical Research Institute @ Harbor-UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Union Memorial
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Minneapolis Vascular Physicians
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55441
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Advance Vascular Associates (Morristown Memorial Hospital)
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
New York University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Shadyside Hospital - University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Baptist Memorial Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
St. Luke's Episcopal Hospital - Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Inova Fairfax Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28366302
Citation
Conrad MF, Tuchek J, Freezor R, Bavaria J, White R, Fairman R. Results of the VALOR II trial of the Medtronic Valiant Thoracic Stent Graft. J Vasc Surg. 2017 Aug;66(2):335-342. doi: 10.1016/j.jvs.2016.12.136. Epub 2017 Mar 30.
Results Reference
derived

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Valor II: The Valiant Thoracic Stent Graft System Clinical Study

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