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New treatment option for Complex Abdominal Aortic Aneurysm
Official title CAAAs, TAAAs, Aortic Arch Aneurysms or Dissections With Fenestrated/Branched Stent Graft
ClinicalTrials.gov ID: NCT02089607
What this study is testing
- What it's testing
- The purpose of this study is to gather safety and effectiveness of the Zenith t-Branch and customized physician-specified stent-graft with a combination of fenestrations and/or branches to repair aortic aneurysm.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- General
- Thoracoabdominal aortic aneurysm with a diameter ≥ 5.5 cm or 2 times the normal aortic diameter.
- Aneurysm with a history of growth ≥ 0.5 cm per year.
- Saccular aneurysms deemed at significant risk for rupture based upon physician interpretation.
- Presence of concomitant thoracoabdominal and aortic arch aneurysm meeting one of the above-mentioned criteria.
You likely can't join if
- Less than 18 years of age
- Unwilling to comply with the follow-up schedule
- Inability or refusal to give informed consent by the patient or a legally authorized representative
- Pregnant or breastfeeding
- Life expectancy \< 2 years
- Prior open surgical or treatment procedure within 30 days of the anticipated date of the fenestrated-branched procedure, with the exception of...
See the full eligibility criteria
Who can join
- General
- Thoracoabdominal aortic aneurysm with a diameter ≥ 5.5 cm or 2 times the normal aortic diameter.
- Aneurysm with a history of growth ≥ 0.5 cm per year.
- Saccular aneurysms deemed at significant risk for rupture based upon physician interpretation.
- Presence of concomitant thoracoabdominal and aortic arch aneurysm meeting one of the above-mentioned criteria.
- Presence of thoracoabdominal aortic aneurysm meeting one of the above-mentioned criteria with unilateral or bilateral common iliac artery aneurysm with diameter ≥ 3.0-cm or saccular morphology with no suitable landing...
What rules you out
- Less than 18 years of age
- Unwilling to comply with the follow-up schedule
- Inability or refusal to give informed consent by the patient or a legally authorized representative
- Pregnant or breastfeeding
- Life expectancy \< 2 years
- Prior open surgical or treatment procedure within 30 days of the anticipated date of the fenestrated-branched procedure, with the exception of planned staged procedures to provide access for repair (e.g. staged iliac...
- Participation in another investigational clinical or device trial, with the exception of participation in another investigational endovascular stent-graft protocol, percutaneous aortic valve protocol, or concomitant...
- Patients with ruptured aortic aneurysms requiring urgent or emergent repair, with the exception of patients with contained, stable ruptures with anatomy suitable for an off-the-shelf design. Medical Exclusion Criteria:
- Known sensitivities or allergies to stainless steel, nitinol, polyester, solder (tin, silver), polypropylene, PTFE, urethane or gold
- History of anaphylactic reaction to contrast material that cannot be adequately pre-medicated
- Leaking or ruptured aneurysm associated with hypotension
- Uncorrectable coagulopathy
- Mycotic aneurysm or patients with evidence of active systemic infection.
- History of connective tissue disorder (e.g vascular Ehlers Danlos, Marfans syndrome), with the exception of those patients who had prior open surgical aortic replacement, where a surgical graft would serve as landing...
- Body habitus that would inhibit X-ray visualization of the aorta and its branches. Anatomical Exclusion Criteria:
- Inadequate femoral or iliac access compatible with the required delivery systems.
- Inability to perform a temporary or permanent open surgical or endovascular iliac conduit for patients with inadequate femoral/iliac access.
- Absence of a non-aneurysmal aortic segment in the distal thoracic aorta above the diaphragmatic hiatus with: a. A diameter measured outer wall to outer wall of no greater than 42mm and no less than 21 mm; b. Parallel...
- Visceral vessel anatomy not compatible with Zenith t-Branch or patient-specific stent-graft due to excessive occlusive disease or small size not amenable to stent graft placement
- Unsuitable distal iliac artery fixation site and anatomy for iliac limb extension or iliac branch device: a. Common iliac artery fixation site diameter, measured outer wall to outer wall on a sectional image (CT) \ 20...
- Proximal aortic fixation zone: a. Native aorta or surgical graft; b. Diameter: 20-42mm; c. Proximal neck length ≥ 20mm; d. Ascending aortic length ≥50mm; e. Must occur distal to coronary arteries and any coronary artery...
- Distal aortic fixation zone:; a. Native aorta or surgical graft; b. Diameter: 20-42mm; c. Distal neck length ≥20mm
- Supra-aortic trunk (brachiocephalic) vessels: a. Although the prosthesis will typically have two branches, modifications to the design will allow for a single branch, three branches or combination of branch and scallop...
- In the setting of an aortic dissection the following criteria must exist: a. Access into the true lumen from the groin and at least one supra-aortic trunk vessel; b. A sealing zone in the target aorta (or surgical...
- In the setting of more distal disease: a. The repair may be coupled with a thoracoabdominal branched device, infrarenal device, and/or internal iliac branch device.
- Iliac anatomy must allow for the delivery of the arch branch device which is loaded within a 20F-24F sheath. Thus the iliac requirements are no different than the standard thoracic protocol. Conduits to the iliac...
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, Minnesota, United States
- Houston, Texas, 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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, Minnesota, United States; Houston, Texas, 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.