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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Endovascular
ClinicalTrials.gov Identifier:
NCT01114724
First received: April 26, 2010
Last updated: July 28, 2014
Last verified: July 2014
  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 will 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:
  • All-cause Mortality [ Time Frame: at 12 months ] [ Designated as safety issue: Yes ]
  • Subjects With Successful Delivery and Deployment of the Device. [ Time Frame: At implant. ] [ Designated as safety issue: Yes ]
  • Subjects With Coverage of Primary Tear [ Time Frame: At implant ] [ Designated as safety issue: Yes ]
  • Aortic Rupture [ Time Frame: Within 30 days ] [ Designated as safety issue: Yes ]
  • Aortic Rupture [ Time Frame: Within 12 months ] [ Designated as safety issue: Yes ]
  • Subjects With Secondary Endovascular Procedures [ Time Frame: Through12 months ] [ Designated as safety issue: Yes ]
  • Aortic Remodeling: Subjects With Partial/Complete False Lumen Thrombosis Over the Stented Segment [ Time Frame: At 6 months ] [ Designated as safety issue: Yes ]
  • Aortic Remodeling: Subjects With Complete/Partial Thrombosis of the False Lumen Over the Stented Segment [ Time Frame: At 12 months ] [ Designated as safety issue: Yes ]
  • Aortic Remodeling: Subjects With Stable (+/- 5mm) or Increase in True Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft [ Time Frame: at 6 months ] [ Designated as safety issue: Yes ]
  • Aortic Remodeling: Subjects With Stable (+/- 5mm) or Increase in True Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft [ Time Frame: at 12 months ] [ Designated as safety issue: Yes ]
  • Aortic Remodeling: Subjects With Stable (+/- 5mm) or Decrease in False Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft [ Time Frame: at 6 months ] [ Designated as safety issue: Yes ]
  • Aortic Remodeling: Subjects With Stable (+/- 5mm) or Decrease in False Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft [ Time Frame: at 12 months ] [ Designated as safety issue: Yes ]
  • Subjects With Device, Procedure and/or Aortic Related Serious Adverse Events. [ Time Frame: at 30 days ] [ Designated as safety issue: Yes ]
  • Subjects With Device, Procedure and/or Aortic Related Serious Adverse Events. [ Time Frame: at 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 50
Study Start Date: May 2010
Estimated Study Completion Date: June 2017
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Valiant Thoracic Stent Graft with the Captivia Delivery System Device: Valiant Thoracic Stent Graft will the Captivia Delivery System
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 signed an informed consent.
  • Subject is at least 18 years old.
  • 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)
  • Visceral ischemia measured by either radiographic or clinical evidence.
  • Renal ischemia measured by either radiographic or clinical evidence.
  • Spinal cord ischemia measured by either radiographic or clinical evidence.
  • Lower limb ischemia measured by either radiographic or clinical evidence.
  • Rupture - Measured by radiographic or clinical evidence.
  • Subject is hemodynamically stable.
  • Subject's anatomy must meet all of the following anatomical criteria:

Proximal landing zone aortic diameter must be between 20 mm and 44 mm;

  • Centerline distance from distal margin of left CCA or in cases of bovine anatomy, innominate artery, to start of most proximal tear must be ≥ 20 mm;
  • Subject has patent iliac or femoral arteries or can tolerate an iliac conduit that allows endovascular access to the dissection site with the delivery system of the appropriate sized device.
  • Thoracic aortic dissection is confirmed, at a minimum, by diagnostic contrast-enhanced computerized tomography angiogram (CTA) with 3-D reconstruction, and/or contrast enhanced magnetic resonance angiogram (MRA) obtained prior to the implant procedure.

Exclusion Criteria

  • Planned placement of the COVERED portion of the stent graft over the left carotid artery, or the celiac trunk.
  • Subject has systemic infection.
  • Subject is pregnant.
  • 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 is currently participating in an investigational drug or device clinical trial which would interfere with the endpoints and follow-ups of this study.
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
University of Florida
Gainesville, Florida, United States, 32610
United States, Illinois
Northwestern Memorial
Chicago, Illinois, United States, 60601
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
Novant Health Heart and Vascular Institute
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
Vanderbilt Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
Heart Hospital Medical Center
Dallas, Texas, United States, 75230
Memorial Hermann Heart and Vascular Institute
Houston, Texas, United States, 77030
St. Luke's Episcopal Hospital
Houston, Texas, United States, 77030
Baylor
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
Results First Received: May 30, 2014
Last Updated: July 28, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Medtronic Endovascular:
Thoracic dissection
Endovascular aortic repair

ClinicalTrials.gov processed this record on October 01, 2014