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

NCT ID: NCT01114724

Last Updated: 2021-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2017-10-31

Brief Summary

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.

Conditions

Aortic Dissection

Keywords

Thoracic dissection; Endovascular aortic repair

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Valiant Thoracic Stent Graft with the Captivia Delivery System

Group Type: EXPERIMENTAL

Valiant Thoracic Stent Graft with the Captivia Delivery System

Intervention Type: DEVICE

All subjects will be implanted with this device

Interventions

Valiant Thoracic Stent Graft with the Captivia Delivery System

All subjects will be implanted with this device

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Medtronic Cardiovascular

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph E. Bavaria, M.D.

Role: PRINCIPAL_INVESTIGATOR

Univ. of Pennsylvania Health System

W. Anthony Lee, M.D., F.A.C.S

Role: PRINCIPAL_INVESTIGATOR

Lynn Heart Institute, Boca Raton Community Hospital

Locations

USC Keck School of Medicine

Los Angeles, California, United States

Cedars Sinai Medical Center

Los Angeles, California, United States

Harbor UCLA

Torrance, California, United States

Washington Hospital D.C.

Washington D.C., District of Columbia, United States

University of Florida

Gainesville, Florida, United States

Northwestern Memorial

Chicago, Illinois, United States

University of Michigan

Ann Arbor, Michigan, United States

New York Presbyterian Weill Cornell

New York, New York, United States

Novant Health Heart and Vascular Institute

Charlotte, North Carolina, United States

Duke University Medical Center

Durham, North Carolina, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Vanderbilt Medical Center

Nashville, Tennessee, United States

Heart Hospital Medical Center

Dallas, Texas, United States

Baylor

Houston, Texas, United States

Memorial Hermann Heart and Vascular Institute

Houston, Texas, United States

St. Luke's Episcopal Hospital

Houston, Texas, United States

Virginia Commonwealth University MCV Richmond

Richmond, Virginia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32654872 (View on PubMed)

Other Identifiers

IP # 118

Identifier Type: -

Identifier Source: org_study_id