Evaluation of Valiant Mona LSA



Status:Recruiting
Conditions:Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:2/6/2019
Start Date:April 2015
End Date:October 2024
Contact:Taryn Dellaripa
Email:taryn.dellaripa@medtronic.com
Phone:541-301-3181

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Evaluation of the Valiant Mona LSA Thoracic Stent Graft System in Descending Thoracic Aortic Aneurysms and Chronic Dissections

The purpose of the Feasibility study is to characterize the safety of the Valiant Mona LSA
Thoracic Stent Graft System, including an assessment of the safety and effectiveness of the
device acutely and at the 30 day visit in the identified subject population. This study will
also evaluate the current instructions for use and may direct changes to the delivery and
deployment steps.

The purpose of the expansion to the Feasibility Study is to characterize the Valiant Mona LSA
Thoracic Stent Graft System, in particular to assess the safety and effectiveness of the
device acutely and at the 30 day visit, in subjects enrolled with chronic, Type B
dissections.


Inclusion Criteria:

- Subject is at least 18 years of age.

- Subject understands and has signed an Informed Consent approved by the Sponsor and by
the IRB for this study.

- Subject must be considered a candidate for revascularization of the LSA. Subject must
be able to tolerate a surgical revascularization of the LSA.

- Subject has a TAA/PAU which will require coverage of the LSA and is:

- a fusiform aneurysm with a diameter of ≥ 5.5 cm OR is > 2 times the diameter of
the non-aneurysmal thoracic aorta; AND/OR

- a saccular aneurysm or PAU (ulcer defined as ≥ 10 mm in depth and 20 mm in
diameter, or symptomatic)

- Subject has a healthy, non-diseased aortic proximal seal zone of at least 20 mm from
the distal end of the LCC ostium to the beginning of the disease, including at least
10 mm between the LSA and the LCC.

- Subject has a non -diseased aortic proximal neck length of >0mm distal to the LSA

- Subject has a non-diseased aortic diameter between 25 mm and 42 mm

- Subject has a non-diseased LSA with a diameter between 8 mm and 13 mm.

- Subject has sufficient landing zone within the LSA to accommodate the BSG without
occlusion of any significant vessels

- Brachial, iliac or femoral artery access vessel morphology (diameter, calcification,
tortuosity) that is compatible with vascular access techniques, the device, or
accessories.

- Introducer sheath is required for all procedures.

- An iliac conduit is required for access if the above requirements are not met.

Exclusion Criteria

- Subjects will be excluded if they have conditions requiring prospective
revascularization of the LSA including:

- Dominant left vertebral artery requiring revascularization

- Prior coronary artery bypass graft utilizing the left mammary artery requiring
revascularization

- Incomplete circle of Willis or other neurological vasculature requiring
revascularization

- Subject has an aneurysmal, tortuous, or atherosclerotic LSA.

- Subject has an acute dissection of the descending thoracic aorta.

- Subject has an intramural hematoma of the descending thoracic aorta.

- Subject has prohibitive calcification, occlusive disease, or tortuosity of intended
fixation sites.

- Subject has circumferential calcification in the external iliac artery or in the
common iliac artery with an intraluminal diameter (ID) less than 10mm at any point
proximal to or at the access vessel site unless a surgical adjunctive procedure is
planned.

- Subject requiring an aortic conduit or direct aortic access

- Subject has an aortic atheroma classified as grade IV or grade V.

- Subject has had previous endovascular repair of the ascending and/or descending
thoracic aorta <30 days of implantation of investigational device or previous repair
was a non-Medtronic device

- Treatment with the Valiant Mona LSA Thoracic Stent Graft system would require
intentional coverage of the left common carotid artery with the stent graft fabric.

- Subject has significant and/or circumferential aortic mural thrombus at either the
proximal or distal attachment sites that would compromise fixation and seal of the
device.

- Subject is a pregnant female.

- Subject has a known allergy or intolerance to the device components.

- Subject is in acute renal failure or has renal insufficiency with a serum creatinine ≥
2.0 mg/dL or is on dialysis.

- Subject has a body habitus which prevents adequate visualization of the aorta.

- Subject has coronary artery disease with unstable angina and who has not received
treatment.

- Subject has a connective tissue disease (e.g. Marfan's syndrome, medial degeneration).

- Subject has active systemic infection and/or a mycotic aneurysm.

- Subject is currently participating in an investigational drug or device clinical trial
that would interfere with the observations of this study.

- Subject has other medical, social, or psychological problems that, in the opinion of
the investigator, will interfere with treatment and follow-up procedures.

- Subject has a life expectancy of less than 1 year.

- Subject requires treatment of an infrarenal aneurysm at the time of the implantation.

- Subject has had previous surgical or endovascular treatment of an infra-renal aortic
aneurysm <30 days of implantation of investigational device.

- Subject has a history of bleeding diathesis, coagulopathy, or refuses blood
transfusion.

- Subject has had a cerebral vascular accident (CVA) within 3 months.

- Subject has had a myocardial infarction (MI) within 3 months.

- Subject has a known hypersensitivity or contraindication to anticoagulants or contrast
media, which is not amenable to pre-treatment.
We found this trial at
9
sites
3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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Philadelphia, PA
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
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Charlotte, NC
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Los Angeles, CA
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Atlanta, Georgia 30322
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Atlanta, GA
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Gainesville, Florida 32608
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Gainesville, FL
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Houston, Texas 77030
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Houston, TX
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600 Gresham Dr
Norfolk, Virginia 23507
(757) 388-3000
Sentara Norfolk General Hospital Sentara Norfolk General Hospital is recognized as the number one ranked...
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Norfolk, VA
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