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

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

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.

Study Overview

• Status: Completed
• Conditions: Aortic Dissection
• Intervention / Treatment: Device: Valiant Thoracic Stent Graft with the Captivia Delivery System

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Valiant Thoracic Stent Graft with the Captivia Delivery System	Device: Valiant Thoracic Stent Graft with the Captivia Delivery System; All subjects will be implanted with this device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
All Cause Mortality.	Up to 30 days after the stent graft implant.

Secondary Outcome Measures

Outcome Measure	Time Frame
All-cause Mortality	at 12 months
Subjects With Successful Delivery and Deployment of the Device.	At implant.
Subjects With Coverage of Primary Tear	At implant
Aortic Rupture	Within 30 days
Aortic Rupture	Within 12 months
Subjects With Secondary Endovascular Procedures	Through12 months
Aortic Remodeling: Subjects With Partial/Complete False Lumen Thrombosis Over the Stented Segment	At 6 months
Aortic Remodeling: Subjects With Complete/Partial Thrombosis of the False Lumen Over the Stented Segment	At 12 months
Aortic Remodeling: Subjects With Stable (+/- 5mm) or Increase in True Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft	at 6 months
Aortic Remodeling: Subjects With Stable (+/- 5mm) or Increase in True Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft	at 12 months
Aortic Remodeling: Subjects With Stable (+/- 5mm) or Decrease in False Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft	at 6 months
Aortic Remodeling: Subjects With Stable (+/- 5mm) or Decrease in False Lumen (>5mm) Compared to First Post-procedural CT Over the Stent Graft	at 12 months
Subjects With Device, Procedure and/or Aortic Related Serious Adverse Events.	at 30 days
Subjects With Device, Procedure and/or Aortic Related Serious Adverse Events.	at 12 months

Collaborators and Investigators

• Sponsor: Medtronic Cardiovascular
• Collaborators: 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

Publications and helpful links

General Publications

• Bavaria JE, Brinkman WT, Hughes GC, Shah AS, Charlton-Ouw KM, Azizzadeh A, White RA. Five-year outcomes of endovascular repair of complicated acute type B aortic dissections. J Thorac Cardiovasc Surg. 2022 Feb;163(2):539-548.e2. doi: 10.1016/j.jtcvs.2020.03.162. Epub 2020 May 13.

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: April 26, 2010
• First Submitted That Met QC Criteria: April 29, 2010
• First Posted (Estimate): May 3, 2010

Study Record Updates

• Last Update Posted (Actual): October 29, 2021
• Last Update Submitted That Met QC Criteria: October 27, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Endovascular aortic repair; Thoracic dissection
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Aneurysm, Dissecting
• Other Study ID Numbers: IP # 118