Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.
Evaluation of the GORE® TAG® Thoracic Branch Endoprosthesis (TBE Device) in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta (Zone 0/1) (SSB 11-02)
The objective of this study is to determine whether the GORE® TAG® Thoracic Branch
Endoprosthesis is safe and effective in treating lesions of the aortic arch and descending
thoracic aorta.
Kyla Bennett
All
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT02777528
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Inclusion Criteria:
1. Presence of thoracic aortic pathology deemed to warrant surgical repair which requires
proximal graft placement in Zone 0-2.
2. Age ≥18 years at time of informed consent signature
3. Subject is capable of complying with protocol requirements, including follow-up
4. Informed Consent Form (ICF) is signed by Subject or legal representative
5. Must have appropriate proximal aortic landing zone.
6. Must have appropriate target branch vessel landing zone.
7. For patients with aneurysm/isolated lesion, must have appropriate distal aortic
landing zone.
8. Native aortic valve (Zone 0/1 subjects only)
9. Subject is considered a high risk candidate for conventional open surgical repair at
the discretion of the Investigator (Zone 0/1 subjects only)
Exclusion Criteria:
1. Concomitant disease of the ascending aorta or aneurysm of the abdominal aorta
requiring repair
2. Previous endovascular repair of the ascending aorta
3. Previous endovascular repair of the DTA with a non-Gore device
4. Surgery within 30 days prior to enrollment, with the exception of surgery for
Ascending Aortic Dissection and/or placement of vascular conduit for access.
5. Infected aorta
6. Life expectancy <2 years
7. Myocardial infarction within 6 weeks prior to treatment
8. Stroke within 6 weeks prior to treatment, stroke defined as rapidly developing
clinical signs of focal (or global) disturbance of cerebral function, lasting more
than 24 hours or leading to death, with no apparent cause other than that of vascular
origin.
9. Patient has a systemic infection and may be at increased risk of endovascular graft
infection
10. Pregnant female at time of informed consent signature
11. Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome
12. Participation in another drug or medical device study within one year of study
enrollment
13. Known history of drug abuse within one year of treatment
14. Presence of protruding and/or irregular thrombus and/or atheroma in the aortic arch or
ascending aorta
15. Tortuous or stenotic iliac and/or femoral arteries preventing introducer sheath
insertion and the inability to use a conduit for vascular access
16. Planned coverage of celiac artery
17. Patient has known sensitivities or allergies to the device materials
18. Patient has known hypersensitivity or contraindication to anticoagulants or contrast
media, which is not amenable to pre-treatment
19. Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known
hypersensitivity to heparin
20. Patient with a history of a hypercoagulability disorder and/or hypercoagulability
state
21. Diameter taper outside of the device sizing range between proximal and distal landing
zones of aorta and the inability to use additional devices of different diameters to
compensate for the taper
22. Mycotic aneurysm
23. Persistent refractory shock (systolic blood pressure <90 mm Hg)
24. Patient has body habitus or other medical condition which prevents adequate
visualization of the aorta
25. Renal failure defined as patients with an estimated Glomerular Filtration Rate (eGFR)
<30 or currently requiring dialysis
26. Patient at high risk of neurological event, e.g. stroke
The purpose of the Registry is to provide continuing evaluation and periodic reporting of
safety and effectiveness of Medtronic market-released products. The Registry data is intended
to benefit and support interests of patients, hospitals, clinicians, regulatory bodies,
payers, and industry by streamlining the clinical surveillance process and facilitating
leading edge performance assessment via the least burdensome approach.
Micah Chan
All
Not specified
N/A
This study is NOT accepting healthy volunteers
NCT01524276
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Inclusion Criteria:
• Patient or legally authorized representative provides written authorization and/or
consent per institution and geographical requirements
• Patient has or is intended to receive or be treated with an eligible Medtronic product
• Patient within enrollment window relative to therapy initiation or meets criteria for
retrospective enrollment
Exclusion Criteria:
• Patient who is, or will be, inaccessible for follow-up
• Patient with exclusion criteria required by local law
• Patient is currently enrolled in or plans to enroll in any concurrent drug and/or
device study that may confound results
Cardiac Rhythm Disorders, Urological Disorders, Neurological Disorders, Cardiovascular Disorders, Digestive Disorders, Intracranial Aneurysm, Mechanical Circulatory Support, Respiratory Therapy, Aortic, Peripheral Vascular and Venous Disorders, Minimally Invasive Surgical Procedures, Diagnostic Techniques and Procedures, Surgical Procedures, Operative, Renal Insufficiency, Neurovascular, Coronary Artery Disease, Ear, Nose and Throat Disorder, Other
Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Thoracoabdominal and Pararenal AorticAneurysms (TAMBE)
Prospective, non-randomized, , multicenter study with two independent arms:
- Primary Study Arm - TAAA and Pararenal aneurysms requiring only TAMBE System.
Hypothesis-driven analysis.
- Up to 65 additional subjects may be implanted in Continued Access Phase under the
Primary Study Arm only
- Secondary Study Arm - TAAA requiring TAMBE System and CTAG Device(s). Non
hypothesis-driven analysis.
Minimum: 122 implanted subjects. Maximum: 202 implanted subjects with up to 65 additional
subjects implanted in Continued Access (Primary Study arm)
Dai Yamanouchi
All
19 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT03728985
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Inclusion Criteria:
1. Aortic aneurysm involving the visceral vessels requiring treatment defined as at least
one of the following:
• Fusiform aneurysm diameter ≥ 5 cm
• Saccular aneurysm (no diameter requirement)
• Rapid aneurysm growth (≥ 5 mm in one year)
2. Aortic aneurysm that involves the abdominal aorta, with:
• Involvement of at least one visceral vessel and aneurysmal extension as far as 65
mm proximal to the celiac artery, and/or
• No normal aorta between the upper extent of aneurysm and renal artery(s)
3. Adequate access for TAMBE Device components (femoral, axillary, and / or brachial
arteries as required)
4. Age ≥ 19 years at the time of informed consent signature
5. Male or infertile female
6. Patient assessment favors an endovascular approach when compared to open surgical
repair, as deemed by the treating physician
7. Capable of complying with protocol requirements, including follow-up
8. An Informed Consent Form signed by Subject or legal representative
9. Sufficient distal landing zones in both iliac arteries, with at least one patent
internal iliac artery and without planned placement of a branched iliac device, or
planned coverage/occlusion/embolization of any patent internal iliac artery.
10. Appropriate aortic anatomy to receive the TAMBE Device defined as all of the
following:
• For the TAMBE aortic component, proximal aortic landing zone diameters between
22-34 mm
• Proximal seal zone ≥ 20 mm in length
• Aortic neck angle ≤ 60°
• Distal landing zone (iliac arteries) 8-25 mm
• Distal seal zone in iliac arteries of at least 10 mm in length
• Renal artery landing zone diameters between 4-10 mm
• Celiac and superior mesenteric artery landing zone diameters between 5-12 mm
• ≥ 15 mm landing zone in each branch vessel
• Landing zones in the proximal and distal aorta and all branch vessels cannot be
aneurysmal, heavily calcified, or heavily thrombosed
• Patent left subclavian artery
Secondary Study Arm Only:
11. If aneurysm extends greater than 65 mm above celiac artery, proximal extension with a
CTAG Device is required. The aortic landing zone diameter treatment range with the
CTAG Device is 19.5-32 mm
12. The most proximal aspect of the aneurysm is at least 2.0 cm distal to the left
subclavian artery.
13. The most proximal aortic device seal zone will be within native aorta or a
previously-deployed TAG or CTAG Device • Placement inside a Dacron graft or another
device manufacturer's stent graft will not be supported
Exclusion Criteria:
The patient is / has:
1. Prior open, aortic surgery of the ascending aorta or aortic arch
2. Ruptured or leaking aortic aneurysm
3. Aneurysmal dilatation due to chronic aortic dissection
4. Infected aorta
5. Mycotic aneurysm
6. Life expectancy <2 years
7. Myocardial infarction or stroke within 1 year of treatment (staged or index procedure)
8. Systemic infection which may increase risk of endovascular graft infection
9. Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome
10. Participation in an investigational drug study (within 30 days of last administration)
or investigational medical device study (within 1 year of implant) from the time of
study screening
11. History of drug abuse, e.g. cocaine or amphetamine or alcohol, within 1 year of
treatment
12. Tortuous or stenotic iliac and / or femoral arteries and the inability to use a
conduit for vascular access
13. A branch vessel(s) that is dissected or has significant calcification, tortuosity,
thrombus formation that would interfere with device delivery or ability to exclude
from blood flow
14. Known sensitivities or allergies to the device materials
15. Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known
hypersensitivity to heparin
16. Patient has body habitus or other medical condition which prevents adequate
fluoroscopic and CT visualization of the aorta
17. Renal Insufficiency (creatinine value > 1.8 mg/dL, GFR < 30, or patient undergoing
dialysis)
18. Known concomitant aneurysm of the ascending aorta or aortic arch anticipated to
require surgical intervention within one year of study treatment
Thoracoabdominal aorticaneurysm, without rupture, Other, Heart & Vascular, Thoracoabdominal AorticAneurysm
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