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

Aortic Dissection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01114724
• Other study ID #: IP # 118
• Status: Completed
• Phase: N/A
• Start date: May 2010
• Est. completion date: October 2017

Study information

• Verified date: October 2021
• Source: Medtronic Cardiovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2017
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm, Dissecting
• Aortic Dissection

Intervention

Device:
• Valiant Thoracic Stent Graft with the Captivia Delivery System
All subjects will be implanted with this device

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Novant Health Heart and Vascular Institute	Charlotte	North Carolina
United States	Northwestern Memorial	Chicago	Illinois
United States	Heart Hospital Medical Center	Dallas	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	University of Florida	Gainesville	Florida
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	Cedars Sinai Medical Center	Los Angeles	California
United States	USC Keck School of Medicine	Los Angeles	California
United States	Vanderbilt Medical Center	Nashville	Tennessee
United States	New York Presbyterian Weill Cornell	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Virginia Commonwealth University MCV Richmond	Richmond	Virginia
United States	Harbor UCLA	Torrance	California
United States	Washington Hospital D.C.	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic Cardiovascular	Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All Cause Mortality.		Up to 30 days after the stent graft implant.
Secondary	All-cause Mortality		at 12 months
Secondary	Subjects With Successful Delivery and Deployment of the Device.		At implant.
Secondary	Subjects With Coverage of Primary Tear		At implant
Secondary	Aortic Rupture		Within 30 days
Secondary	Aortic Rupture		Within 12 months
Secondary	Subjects With Secondary Endovascular Procedures		Through12 months
Secondary	Aortic Remodeling: Subjects With Partial/Complete False Lumen Thrombosis Over the Stented Segment		At 6 months
Secondary	Aortic Remodeling: Subjects With Complete/Partial Thrombosis of the False Lumen Over the Stented Segment		At 12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Subjects With Device, Procedure and/or Aortic Related Serious Adverse Events.		at 30 days
Secondary	Subjects With Device, Procedure and/or Aortic Related Serious Adverse Events.		at 12 months