Ensayos clínicos

General Inclusion Criteria:

• 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.

General Exclusion Criteria:

• 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 interventional 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 conduit, cervical debranching), to facilitate the procedure by allowing open revascularization of a target artery not amenable to revascularization with the investigational device, such as an internal iliac artery, subclavian artery or visceral artery with early bifurcation, tortuosity or occlusive disease preventing successful placement of alignment side stents.
• Participation in another investigational clinical or device trial, with the exception of participation in another investigational endovascular stent-graft protocol or percutaneous aortic valve protocol, not encompassed by the IDE protocol and performed remotely from the fenestrated procedure (> 30 days). Examples include remote (>30 days) participation in a thoracic, abdominal or iliac branch device trial, or participation in a percutaneous aortic valve trial.
• 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, polytetrafluoroethylene (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 zone for the investigational stent-graft.
• 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 diameter measured outer wall to outer wall of no greater than 38mm and no less than 21 mm;
  • Parallel aortic wall with <20% diameter change and without significant calcification and/or thrombus in the selected area of seal zone.
• Visceral vessel anatomy not compatible with Zenith t-Branch or physician-specified stent-graft due to excessive occlusive disease or small size not amenable to stent graft placement.
• Unsuitable distal iliac artery fixation site and anatomy:
  • Common iliac artery fixation site diameter, measured outer wall to outer wall on a sectional image (CT) <8.0 mm with inability to perform open surgical conduit;
  • Iliac artery diameter, measured outer wall to outer wall on a sectional image (CT) >21 mm at distal fixation site, with inability to perform open internal iliac artery revascularization or iliac branch stent graft;
  • Non-aneurysmal external liac artery distal fixation site <10 mm in [JRW1] length;
  • Non-aneurysmal internal iliac artery main trunk or branch segment with length <10mm or with inner wall diameter <4 or >14mm;
  • Unsuitable anatomy due to inability to preserve at least one hypogastric artery. 
• Proximal aortic fixation zone:
  • Native aorta or surgical graft;
  • Diameter: 20-42mm;
  • Proximal neck length ≥ 20mm;
  • Ascending aortic length ≥50mm;
  • Must occur distal to coronary arteries and any coronary artery bypass grafts that are considered patent and necessary for proper cardiac perfusion.
• Distal aortic fixation zone:
  • Native aorta or surgical graft;
  • Diameter: 20-42mm;
  • Distal neck length ≥20mm.
• Supra-aortic trunk (brachiocephalic) vessels:
  • 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 if a customized version is required.Thus, it is generally planned that at least one extra-anatomic bypass graft will be done in conjunction (or in a staged fashion) with the procedure, unless three branches are planned.The two vessels incorporated into the endograft repair would most commonly be the innominate artery and left common carotid artery.However, the innominate artery may be coupled with the left subclavian artery in the setting of a bovine arch whereby the flow to the left carotid would come from a left subclavian to carotid bypass.Similarly, the left carotid and subclavian artery may be branched, or simply one vessel branched should specific anatomic limitations exist.In such a situation, multiple extra-anatomic bypasses may be necessary. A design with a single subclavian retrograde branch and double scallop to the left carotid artery may be used to extent the landing zone to Zone 1. Finally, a design with two antegrade inner branches for the innominate and left common carotid, and one retrograde inner branch for the left subclavian artery may be used in select cases. Thus, the inclusion criteria are defined for each artery, yet any combination of arteries may be used for a repair.
• Innominate artery:
  • Native vessel or surgical graft;
  • Diameter: 8-22mm;
  • Length of sealing zone ≥10mm;
  • Acceptable tortuosity.
• Left (or right) common carotid artery:
  • Native vessel or surgical graft;
  • Diameter 6-16mm;
  • Length of sealing zone ≥10mm;
  • Acceptable tortuosity.
• Left (or right) subclavian artery:
  • Native vessel or surgical graft;
  • Diameter: 5-20mm;
  • Length of sealing zone ≥10mm;
  • Acceptable tortuosity.
• In the setting of an aortic dissection the following criteria must exist:
  • Access into the true lumen from the groin and at least one supra-aortic trunk vessel;
  • A sealing zone in the target aorta (or surgical graft) that is proximal to the primary dissection, such that a stent-graft would be anticipated to seal off the dissection lumen;
  • A sealing zone in the target supra-aortic trunk vessels that is distal to the dissection, anticipated to seal off the dissection lumen, or surgically created;
  • A true lumen size large enough to deploy the device and still gain access into the target branches.
• 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 vessels or aorta may be used if deemed necessary.