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Therapeutic Areas: Cardiology/Vascular Diseases
Disease Category: Cardiovascular Abnormalities
Location: United States, TX
Evaluation of the clinical performance of the Valiant thoracic Stent Graft with the Captivia Delivery System for the treatment of acute, complicated type B aortic dissections.
This study is a multi-center trial designed to evaluate the safety and effectiveness of the Valiant Captivia in the endovascular treatment of acute, complicated Type B aortic dissections of the descending thoracic aorta (DTA). Instead of replacing the damaged segments of the aorta with a dacron graft, which can result in significant blood loss, aortic clamping, and a thoracotomy, an endovascular stent graft repair consists of transfemoral or iliac introduction of a metallic stent which is coupled with a vascular graft. The stent graft device is deployed and expanded in the diseased blood vessel, which creates a new aortic lumen for blood flow, excluding the lesion from blood flow while maintaining perfusion to the lower limbs. The goal is to collapse the false lumen allowing it to thrombose, a process that mimics the natural healing process and may eventually lead to reconstruction and remodeling of the entire aorta.
Principal Investigator: William Brinkman, MD
Sub-investigators: Dennis Gable, MD, David Moore, MD, William Shutze, MD
The endpoints of this study include all cause mortality within 30 days, 12 months and annually for 5 years of the procedure, successful delivery and deployment of the stent graft, coverage of the proximal entry tear, aortic remodeling, and rupture.
- Subject has an acute, complicated type B aortic dissection with evidence of malperfusion or rupture.
- Subject is hemodynamically stable.
- Subject’s anatomy meets all the following criteria: Proximal landing zone aortic diameter must be between 20mm and 44mm, Centerline distance from distal margin of common artery to start of most proximal tear must be greater than 20mm, and subject has patent iliac or femoral arteries.
- Thoracic aortic dissection is confirmed by CTA with 3-D reconstruction and/or MRA.
- 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 within 2 months.
- Subject has a history of bleeding diasthesis, coagulopathy, or refuses blood transfusion.
- 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 constrast media, which is not amenable to pre-treatment.
- Subject has a co-morbidity causing expected survival to be less than 1 year.
Follow up procedures include ABIs, CT Angios of the chest, abdomen and pelvis before discharge, 30 days, 6 and 12 months and then annually for five years post procedure.
If you have any questions or need more information regarding this trial, please contact Jennifer Withers, RN, BSN at 469-814-5691 (W) or email@example.com or Mary deHaas, Research Manager at 469-814-4712 (firstname.lastname@example.org).
Jennifer Withers, RN, BSN
Baylor Research Institute
3600 Gaston Ave, Wadley #656
Dallas, TX 75246
Research Center Information: Baylor Research Institute
If you would like to learn more about participating in this study, please send an email message using the form below.
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