Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
30 participants
INTERVENTIONAL
2010-01-31
2015-12-31
Brief Summary
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Detailed Description
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* Females subjects must be either documented post-menopausal, surgically incapable of bearing children, or for women of childbearing potential, using barrier contraceptive methods and must have a negative serum pregnancy test at screening.
* Subject is a candidate for endovascular thoracic aortic repair.
* Subject has a TAA that meets one of the following criteria:
* Is diagnosed with a Fusiform Focal TAA \>5cm, or
* Is diagnosed with a Fusiform Focal TAA that has a diameter \< 5 cm and has exhibited rapid expansion, or
* Is diagnosed with a Fusiform Focal TAA that has a diameter ≥ 4.5 cm and is at least twice the size of the normal DTA, or
* Is diagnosed with a saccular TAA of any size.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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TAArget Thoracic Stent Graft
those treated with the investigational device
Endovascular repair of TAA in the descending Thoracic Aorta
Usage of the TAArget thoracic stent graft for treatment of TAA in the Descending Thoracic Aorta.
Interventions
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Endovascular repair of TAA in the descending Thoracic Aorta
Usage of the TAArget thoracic stent graft for treatment of TAA in the Descending Thoracic Aorta.
Eligibility Criteria
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Inclusion Criteria
Subject is a candidate for endovascular thoracic aortic repair.
Subject has a TAA that meets one of the following criteria:
1. Is diagnosed with a Fusiform Focal TAA ≥5cm, or
2. Is diagnosed with a Fusiform Focal TAA that has a diameter ≤ 5 cm and has exhibited rapid expansion, or
3. Is diagnosed with a Fusiform Focal TAA that has a diameter ≥ 4.5 cm and is at least twice the size of the normal DTA, or
4. Is diagnosed with a saccular TAA of any size (where potential for rupture is increased\*).
* Tortuosity and angulation do not exceed 90 degrees.
* Subject has an arterial access site that allows for the introduction of the stent-graft delivery system.
Exclusion Criteria
* Subject has a lesion that prevents safe delivery or expansion of the device.
* Subject has concomitant ascending aortic aneurysm.
* Subject has known allergies to any of the device materials.
* Subject has coagulopathy or bleeding disorders that cannot be pre-treated.
* Subject is contraindicated for contrast medium and anticoagulation drugs that cannot be pre-treated.
18 Years
ALL
No
Sponsors
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Duke Vascular, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Kartikeshwar Kasirajan, M.D.
Role: PRINCIPAL_INVESTIGATOR
Emory University Medical School
Locations
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Christiana Hospital
Newark, Delaware, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Countries
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Other Identifiers
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LMV-TAA-P1-001
Identifier Type: -
Identifier Source: org_study_id
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