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New treatment option for Aortic Aneurysm, Thoracoabdominal
Official title Physician-Modified Fenestrated and Branched Aortic Endografting for TAAA
ClinicalTrials.gov ID: NCT02989948
What this study is testing
- What it's testing
- The primary clinical objective of this study is to evaluate the safety and effectiveness of a physician-modified, fenestrated and branched aortic endoprosthesis for the treatment of thoracoabdominal aortic aneurysms (TAAAs). The goal of the primary analysis is to demonstrate both the safety and effectiveness of using a physician-modified fenestrated Cook Zenith Alpha Thoracic Endovascular Graft as compared to previously published results of open surgical replacement of the aneurysmal aorta.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 95
You may be able to join if
- MAIN ARM -
- Must be a man or woman 50 years of age or older by the date of informed consent.
- Must have a thoracoabdominal aortic aneurysm of any Crawford classification (extent I-V) that extends no more proximal than the left subclavian...
- Must have an aneurysm size that meets standard indications for surgical repair (6.0 cm in maximum diameter in the descending thoracic aorta, or 5.5...
- Must be considered, in the judgment of the S-I, to be a high risk candidate for open surgical repair.
You likely can't join if
- Aneurysm due to acute or chronic dissection, intramural hematoma, penetrating aortic ulceration, pseudoaneurysm, mycotic aneurysm, or traumatic...
- Ruptured or acutely symptomatic aortic aneurysm.
- Known connective tissue disorder.
- Imaging demonstrating any of the following:
- Lack of 20 mm non-aneurysmal proximal seal zone (zone 3, or zone 2 with a carotid-subclavian bypass or transposition).
- Lack of 15 mm non-aneurysmal distal seal zone(s) (aortic, common iliac, or external iliac).
See the full eligibility criteria
Who can join
- MAIN ARM -
- Must be a man or woman 50 years of age or older by the date of informed consent.
- Must have a thoracoabdominal aortic aneurysm of any Crawford classification (extent I-V) that extends no more proximal than the left subclavian artery.
- Must have an aneurysm size that meets standard indications for surgical repair (6.0 cm in maximum diameter in the descending thoracic aorta, or 5.5 cm in maximum diameter in the abdominal aorta).
- Must be considered, in the judgment of the S-I, to be a high risk candidate for open surgical repair.
- Must not be a candidate for repair under the Instructions for Use of a commercially available, FDA-approved endovascular graft.
- Must be able to provide informed consent.
- Must be able to comply with the five year study assessment schedule of events.
- Must have a non-aneurysm-related life expectancy, in the judgment of the S-I, of greater than 2 years. MAIN ARM -
What rules you out
- Aneurysm due to acute or chronic dissection, intramural hematoma, penetrating aortic ulceration, pseudoaneurysm, mycotic aneurysm, or traumatic transection.
- Ruptured or acutely symptomatic aortic aneurysm.
- Known connective tissue disorder.
- Imaging demonstrating any of the following:
- Lack of 20 mm non-aneurysmal proximal seal zone (zone 3, or zone 2 with a carotid-subclavian bypass or transposition).
- Lack of 15 mm non-aneurysmal distal seal zone(s) (aortic, common iliac, or external iliac).
- Branch vessel target (renal, superior mesenteric, or celiac) \ 10 mm in average diameter.
- Untreated left subclavian artery stenosis or occlusion.
- Untreated unilateral or bilateral hypogastric artery occlusion.
- Signs that the inferior mesenteric artery is indispensable.
- Have branching, duplication, aneurysm, or untreatable stenosis of the celiac, superior mesenteric artery, or renal arteries that would preclude implantation of the investigational devices.
- Known sensitivities or allergies to stainless steel, PTFE, polyester, polypropylene, nitinol, or gold.
- History of anaphylaxis to contrast, with inability to prophylax appropriately.
- Have uncorrectable coagulopathy.
- Have unstable angina.
- Have a body habitus that would inhibit X-ray visualization of the aorta.
- Have a major surgical or treatment procedure unrelated to the treatment of the aneurysm planned ≤30 days of the endovascular repair.
- Known to be participating in any other clinical study which may affect performance of this device.
- Known, visible, or suspected pregnancy, confirmed with a Urine Pregnancy Test (UPT)
- Contraindication to oral antiplatelet therapy.
- Prisoners or those on alternative sentencing.
- Known systemic infection with potential for endovascular graft infection.
- Anticipated need for MRI scanning within 3 months of insertion of investigational product.
- Other conditions or comorbidities that, in the opinion of the S-I, would exclude the patient. EXPANDED ACCESS ARM - Inclusion Criteria
- Must be a man or woman 50 years of age or older by the date of informed consent
- Must have a thoracic, thoracoabdominal, or abdominal aortic aneurysm that necessitates coverage of one or more visceral vessels (celiac, superior mesenteric, or renals) for establishment of proximal and/or distal seal.
- Must have an aneurysm size that meets standard size indications for surgical repair (6.0 cm in maximum diameter in the descending thoracic aorta, or 5.5 cm in maximum diameter in the abdominal aorta); or, in the...
- Must be considered, in the judgement of the S-I, to be a high risk candidate for open surgical repair
- Must not be a candidate for repair under the Instructions for Use of a commercially available, FDA-approved endovascular graft
- Patient must be able to provide informed consent
- Must be able to comply with the five year study assessment schedule of events
- Must have a non-aneurysm-related life expectancy, in the judgement of the S-I, of greater than 2 years EXPANDED ACCESS ARM - Exclusion Criteria
- Known or suspected mycotic aneurysm
- Ruptured aneurysm with hemodynamic instability
- Known connective tissue disorder
- Imaging demonstrating any of the following:
- Lack of 20 mm non-aneurysmal proximal seal zone (in either native aorta, elephant trunk graft, or aortic arch endograft)
- Lack of 15 mm non-aneurysmal distal seal zone(s) (in either native aortoiliac vessels, prosthetic aortoiliac grafts, or aortoiliac endografts)
- Branch vessel target (renal, superior mesenteric, or celiac) \> 10 mm in average diameter
- Known sensitivities or allergies to stainless steel, PTFE, polyester, polypropylene, nitinol, or gold
- History of anaphylaxis to contrast, with inability to prophylax appropriately.
- Have uncorrectable coagulopathy
- Have a body habitus that would inhibit X-ray visualization of the aorta
- Have a major surgical or treatment procedure unrelated to the treatment of the aneurysm planned ≤ 30 days of the endovascular repair
- Known to be participating in any other clinical study which may affect performance of this device
- Known, visible, or suspected pregnancy, confirmed with a Urine Pregnancy Test (UPT)
- Contraindication to oral antiplatelet therapy
- Prisoners or those on alternative sentencing
- Known systemic infection with potential for endovascular graft infection
- Anticipated need for MRI scanning within 3 months of insertion of investigational product
- Other conditions or comorbidities that, in the opinion of the S-I, would exclude the patient
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
- Lebanon, New Hampshire, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 95 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States; Lebanon, New Hampshire, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.