Study to Evaluate the Clinical Performance of the Valiant Thoracic Stent Graft With the Captivia Delivery System (Valiant Captivia) for the Treatment of Acute, Complicated Type B Aortic Dissections - Full Text View

Purpose

The purpose of this study is to determine if the Valiant stent graft is safe and effective in treating patients who have a thoracic dissection. A thoracic dissection is a tear in the wall of the aorta, that causes blood to flow between the layers of the aorta and force the layers apart(dissect). This condition is a medical emergency and can quickly lead to death. Since stent grafting has been an effective way to treat other aortic conditions such as aneurysms (bulge in aorta wall), it is believed that the device would be effective in treating dissections. Information will be collected on the performance of the device for 5 years.

Condition	Intervention
Aortic Dissection	Device: Valiant Thoracic Stent Graft with the Captivia Delivery System

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Valiant® Thoracic Stent Graft With the Captivia Delivery System. Evaluation of the Clinical Performance of the Valiant Thoracic Stent Graft With the Captivia Delivery System (Valiant Captivia) for the Treatment of Acute, Complicated Type B Aortic Dissections

Further study details as provided by Medtronic Endovascular:

Primary Outcome Measures:

All cause mortality. [ Time Frame: Up to 30 days after the stent graft implant. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Successful delivery and deployment of the device. [ Time Frame: At time of implant. ] [ Designated as safety issue: Yes ]
Change in the aorta. [ Time Frame: At 6 and 12 months. ] [ Designated as safety issue: Yes ]
The device covers the tear in the aorta. [ Time Frame: At implant through 60 months. ] [ Designated as safety issue: Yes ]
Secondary aortic repair [ Time Frame: Up to 60 months after the implant. ] [ Designated as safety issue: Yes ]
Device, procedure and/or aortic related serious adverse events. [ Time Frame: Up to 60 months after the implant. ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	50
Study Start Date:	May 2010
Estimated Study Completion Date:	June 2017
Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Intervention Details:

All subjects with be implanted with this device

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject has an acute, complicated Type B aortic dissection with evidence of at least one of the following:
Malperfusion (visceral, renal, spinal cord and/or lower limb ischemia).
Rupture.
Subject's anatomy must meet the anatomical criteria to receive that implanted device.

Exclusion Criteria:

Planned placement of the COVERED portion of the stent graft over the left carotid artery, or the celiac trunk.
Subject has received a previous stent or stent graft or previous surgical repair in the DTA.
Subject has had a cerebral vascular accident (CVA) within 2 months.
Subject has a history of bleeding diathesis, coagulopathy, or refuses blood transfusion.
Subject has a history of Marfan Syndrome or other connective tissue disorder.
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 a co-morbidity causing expected survival to be less than 1 year.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01114724

Locations

United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
USC Keck School of Medicine
Los Angeles, California, United States, 90033
Harbor UCLA
Torrance, California, United States, 90502
United States, District of Columbia
Washington Hospital D.C.
Washington, DC, District of Columbia, United States, 20010
United States, Florida
Boca Raton Regional Hospital
Boca Raton, Florida, United States, 33486
University of Florida
Gainesville, Florida, United States, 32610
United States, Illinois
Northwestern Memorial
Chicago, Illinois, United States, 60601
Loyola
Maywood, Illinois, United States, 60153
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, New York
New York Presbyterian Weill Cornell
New York, New York, United States, 10065
United States, North Carolina
Presbyterian Hospital
Charlotte, North Carolina, United States, 28204
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
University of Tennessee
Knoxville, Tennessee, United States, 37920
Vanderbilt Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
Heart Hospital Medical Center
Dallas, Texas, United States, 75230
Baylor
Houston, Texas, United States, 77030
Memorial Hermann Heart and Vascular Institute
Houston, Texas, United States, 77030
St. Luke's Episcopal Hospital
Houston, Texas, United States, 77030
United States, Virginia
Virginia Commonwealth University MCV Richmond
Richmond, Virginia, United States, 23298

Sponsors and Collaborators

Medtronic Endovascular

Medtronic

Investigators

Principal Investigator:	Joseph E. Bavaria, M.D.	Univ. of Pennsylvania Health System
Principal Investigator:	W. Anthony Lee, M.D., F.A.C.S	Lynn Heart Institute, Boca Raton Community Hospital

More Information

No publications provided

Responsible Party:	Medtronic Endovascular
ClinicalTrials.gov Identifier:	NCT01114724 History of Changes
Other Study ID Numbers:	IP # 118
Study First Received:	April 26, 2010
Last Updated:	February 1, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Medtronic Endovascular:

Thoracic dissection
Endovascular aortic repair

ClinicalTrials.gov processed this record on June 17, 2013