VALOR: The Talent Thoracic Stent Graft System Clinical Study
This study has been completed.
Sponsor:
Medtronic Endovascular
Information provided by (Responsible Party):
Medtronic Endovascular
ClinicalTrials.gov Identifier:
NCT00604799
First received: December 21, 2007
Last updated: July 16, 2012
Last verified: July 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Thoracic Aortic Aneurysms |
Device: Talent Thoracic Stent Graft |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Evaluation of the Medtronic Vascular Talent Thoracic Stent Graft System for the Treatment of Thoracic Aortic Aneurysms |
Resource links provided by NLM:
Further study details as provided by Medtronic Endovascular:
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. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
| Enrollment: | 379 |
| Study Start Date: | July 2003 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Test (Enrollment Completed)
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.
|
Device: Talent Thoracic Stent Graft
TEVAR
|
|
Registry (Enrollment Completed)
Surgical candidates of low to moderate risk (SVS 0, 1, 2) that meet the Registry Inclusion/Exclusion criteria.
|
Device: Talent Thoracic Stent Graft
TEVAR
|
|
High Risk (Enrollment Completed)
Patients that meet one or more of the following:
|
Device: Talent Thoracic Stent Graft
TEVAR
|
|
Talent Captivia (Recruiting)
Patients diagnosed with a TAA of degenerative etiology that are considered candidates for open surgical repair who meet inclusion/exclusion criteria.
|
Device: Talent Thoracic Stent Graft
TEVAR
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00604799
Locations
| United States, Pennsylvania | |
| University of Pennsylvania Hospital | |
| Philadelphia, Pennsylvania, United States, 19104 | |
Sponsors and Collaborators
Medtronic Endovascular
Investigators
| Principal Investigator: | Mark Kaye, MD | Physician's Regional Medical Center |
| Principal Investigator: | Phillip Allmendinger, MD | Hartford Hospital |
| Principal Investigator: | Mark Bates, MD | CAMC Health System |
| Principal Investigator: | Daniel Benckart, MD | West Penn Allegheny Health System |
| Principal Investigator: | Paul Bove, MD | William Beaumont Hospitals |
| Principal Investigator: | Thomas Bower, MD | Mayo Clinic |
| Principal Investigator: | Alfio Carroccio, MD | Mt. Sinai School of Medicine |
| Principal Investigator: | Neal Cayne, MD | NYU Vascular Associates |
| Principal Investigator: | Frank Criado, MD | Union Memorial Hospital |
| Principal Investigator: | Alan Matsumoto, MD | University of Virginia |
| Principal Investigator: | Mark Eskandari, MD | Northwestern Memorial Hospital |
| Principal Investigator: | Ronald Fairman, MD | University of Pennsylvania |
| Principal Investigator: | Mark Farber, MD | University of North Carolina |
| Principal Investigator: | James McKinsey, MD | New York Presbyterian (Columbia & Cornell) |
| Principal Investigator: | Mark Fillinger, MD | Dartmouth-Hitchcock Medical Center |
| Principal Investigator: | H. Edward Garrett, MD | Baptist Memorial Hospital |
| Principal Investigator: | Marc Glickman, MD | Sentar Norfolk General |
| Principal Investigator: | Kim Hodgson, MD | Memorial Medical Center |
| Principal Investigator: | Matthew Jung, MD | Surgical Care Associates |
| Principal Investigator: | Barry Katzen, MD | Baptist Health South Florida |
| Principal Investigator: | Zvonimir Krajcer, MD | St. Luke's Episcopal Hospital-Houston |
| Principal Investigator: | Christopher Kwolek, MD | Massachusetts General Hospital |
| Principal Investigator: | Lowell Satler, MD | Washington Hospital Center |
| Principal Investigator: | Anthony Lee, MD | University of Florida |
| Principal Investigator: | Alan Lumsden, MD | Baylor College of Medicine |
| Principal Investigator: | Sean Lyden, MD | Cleveland Clinic Foundation-Ohio |
| Principal Investigator: | Richard McCann, MD | Duke University |
| Principal Investigator: | Manish Mehta, MD | Vascular Group, PLLC |
| Principal Investigator: | Mark Mewissen, MD | St. Luke's Vascular Center |
| Principal Investigator: | Takao Ohki, MD | Montefiore Medical Center |
| Principal Investigator: | Venkatesh Ramaiah, MD | Arizona Heart Institute |
| Principal Investigator: | Robert Rhee, MD | Shadyside Hospital-UPMC |
| Principal Investigator: | Timothy Roush, MD | Carolinas Medical Center |
| Principal Investigator: | Gregoria Sicard, MD | Washington University School of Medicine |
| Principal Investigator: | Cary Stowe, MD | Florida Hospital |
| Principal Investigator: | Jim Swischuk, MD | Saint Francis Memorial Hospital |
| Principal Investigator: | Michael Tuchek, MD | Loyola University |
| Principal Investigator: | Rodney White, MD | Harbor UCLA |
| Principal Investigator: | David Williams, MD | University of Michigan |
| Principal Investigator: | Christopher Zarins, MD | Stanford University |
More Information
No publications provided
| Responsible Party: | Medtronic Endovascular |
| ClinicalTrials.gov Identifier: | NCT00604799 History of Changes |
| Other Study ID Numbers: | Investigational Plan #031 |
| Study First Received: | December 21, 2007 |
| Last Updated: | July 16, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Aneurysm Aortic Aneurysm Aortic Aneurysm, Thoracic |
Vascular Diseases Cardiovascular Diseases Aortic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013