Valor II: The Valiant Thoracic Stent Graft System Clinical Study

Thoracic Aortic Aneurysm Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00413231
• Other study ID #: Investigational Plan #078
• Status: Completed
• Phase: N/A
• Start date: December 2006
• Est. completion date: October 2014

Study information

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

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: October 2014
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Aneurysm, Dissecting
• Aortic Aneurysm
• Aortic Aneurysm, Thoracic
• Thoracic Aortic Aneurysm

Intervention

Device:
• Valiant Thoracic Stent Graft System
Surgical procedure in which a device is implanted inside the aorta, isolating the diseased area (aneurysm).

Locations

Country	Name	City	State
United States	Albany Medical Center	Albany	New York
United States	Emory University Hospital	Atlanta	Georgia
United States	Union Memorial	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of North Carolina	Chapel Hill	North Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Inova Fairfax Hospital	Falls Church	Virginia
United States	University of Florida	Gainesville	Florida
United States	Hartford Hospital	Hartford	Connecticut
United States	Baylor College of Medicine	Houston	Texas
United States	St. Luke's Episcopal Hospital - Houston	Houston	Texas
United States	University of Southern California - Healthcare Consultation Center	Los Angeles	California
United States	Loyola University Medical Center	Maywood	Illinois
United States	Baptist Memorial Hospital	Memphis	Tennessee
United States	Advance Vascular Associates (Morristown Memorial Hospital)	Morristown	New Jersey
United States	Mount Sinai School of Medicine	New York	New York
United States	New York University Medical Center	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Shadyside Hospital - University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Minneapolis Vascular Physicians	Plymouth	Minnesota
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	University of South Florida	Tampa	Florida
United States	Los Angeles Biomedical Research Institute @ Harbor-UCLA Medical Center	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiovascular

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	Percentage of Participants That Experienced Paraplegia	Percentage of subjects that experienced paraplegia within 30 days post treatment	Within 30 days post treatment
Secondary	Percentage of Participants That Experienced Paraparesis	Percentage of subjects that experienced paraparesis within 30 days post treatment	Within 30 days post treatment
Secondary	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
Secondary	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
Secondary	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
Secondary	Percentage of Participants That Experience Aneurysm Rupture	Percentage of subjects that experience aneurysm rupture within 12 months post treatment	Within 12 months post treatment
Secondary	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
Secondary	Percentage of Participants That Experienced Endoleak(s)	Percentage of subjects that experienced endoleak(s) of any type at 12 months	At 12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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