Valor II: The Valiant Thoracic Stent Graft System Clinical Study

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.

This study was designed to study safety and effectiveness of the Valiant Thoracic Stent Graft to treat thoracic aortic aneurysms.

Study Overview

• Status: Completed
• Conditions: Thoracic Aortic Aneurysm
• Intervention / Treatment: Device: Valiant Thoracic Stent Graft System

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.

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
  • California
    • Los Angeles, California, United States, 90033
      • University of Southern California - Healthcare Consultation Center
    • Torrance, California, United States, 90502
      • Los Angeles Biomedical Research Institute @ Harbor-UCLA Medical Center
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Hartford Hospital
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida
    • Tampa, Florida, United States, 33606
      • University of South Florida
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
  • Illinois
    • Maywood, Illinois, United States, 60153
      • Loyola University Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21218
      • Union Memorial
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital
  • Minnesota
    • Plymouth, Minnesota, United States, 55441
      • Minneapolis Vascular Physicians
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Advance Vascular Associates (Morristown Memorial Hospital)
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical Center
    • New York, New York, United States, 10016
      • New York University Medical Center
    • New York, New York, United States, 10029
      • Mount Sinai School of Medicine
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15232
      • Shadyside Hospital - University of Pittsburgh Medical Center
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • Baptist Memorial Hospital
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
    • Houston, Texas, United States, 77030
      • St. Luke's Episcopal Hospital - Houston
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia
    • Falls Church, Virginia, United States, 22042
      • Inova Fairfax Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Valiant Thoracic Stent Graft System; 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.	Device: Valiant Thoracic Stent Graft System; Surgical procedure in which a device is implanted inside the aorta, isolating the diseased area (aneurysm).; Other Names: Valiant device; Valiant stent graft.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	0 through 1825 days post treatment
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).	At 12-month post procedure
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.	Within 12-months post treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At implant
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.	Within 30 days post treatment
Percentage of Participants That Experienced Paraplegia	Percentage of subjects that experienced paraplegia within 30 days post treatment	Within 30 days post treatment
Percentage of Participants That Experienced Paraparesis	Percentage of subjects that experienced paraparesis within 30 days post treatment	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	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	Within 30 days post treatment
Percentage of Participants That Experienced Aneurysm-related Mortality	Percentage of subjects that experienced aneurysm-related mortality within 12 months post treatment	Within 12 months post treatment
Percentage of Participants That Experience Aneurysm Rupture	Percentage of subjects that experience aneurysm rupture within 12 months post treatment	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	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	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	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.	Within 12 months post treatment
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	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	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	0 through 1825 days post treatment
Percentage of Participants That Experienced Aneurysm-related Mortality	Percentage of subjects that experienced aneurysm-related within five years post implant	0 through 1825 days post treatment
Percentage of Participants That Experienced Aneurysm Ruptures	Percentage of subjects that experienced aneurysm ruptures within five years post implant	0 through 1825 days post treatment
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	0 through 1825 days post treatment
Percentage of Participants That Experienced Type I Endoleaks	Percentage of subjects that experienced type I endoleaks within five years post implant	0 through 1825 days post treatment
Percentage of Participants That Experienced Type III Endoleaks	Percentage of subjects that experienced type III endoleaks within five years post implant	0 through 1825 days post treatment
Percentage of Participants That Experienced Type IV Endoleaks	Percentage of subjects that experienced type IV endoleaks within five years post implant	0 through 1825 days post treatment
Percentage of Participants That Experienced Secondary Endovascular Procedures	Percentage of subjects that experienced secondary endovascular procedures within five years post implant	0 through 1825 days post treatment
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	0 through 1825 days post treatment
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	0 through 1825 days post treatment

Collaborators and Investigators

• Sponsor: Medtronic Cardiovascular

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2006
• Primary Completion (ACTUAL): August 1, 2010
• Study Completion (ACTUAL): October 1, 2014

Study Registration Dates

• First Submitted: December 15, 2006
• First Submitted That Met QC Criteria: December 15, 2006
• First Posted (ESTIMATE): December 19, 2006

Study Record Updates

• Last Update Posted (ACTUAL): November 3, 2021
• Last Update Submitted That Met QC Criteria: October 27, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Endograft; Thoracic Aneurysm; Endovascular Aortic Repair (EVAR); Endovascular Stent Graft; Thoracic Aortic Aneurysm; Endovascular procedure; Descending Thoracic Aneurysm; Valiant Stent Graft System
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aneurysm, Dissecting; Aortic Aneurysm; Aortic Aneurysm, Thoracic
• Other Study ID Numbers: Investigational Plan #078