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Complex Abdominal, TAAA, Aortic Arch Aneurysm or Dissections With Fenestrated/Branched Stent Graft

Primary Purpose

Complex Abdominal Aortic Aneurysm, Thoracoabdominal Aortic Aneurysm, Aortic Arch Aneurysm

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Thoracoabdominal Aortic Aneurysm Arm
Aortic Arch Aneurysm Arm
Sponsored by
Gustavo Oderich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complex Abdominal Aortic Aneurysm focused on measuring aneurysm, aortic aneurysm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.
  • 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 zone proximal to iliac bifurcation.

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, elephant trunk repair), 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, percutaneous aortic valve protocol, or concomitant clinical trials designed to evaluate medical therapy strategies to reduce perioperative risk during fenestrated-branched endovascular repair, including risks of renal dysfunction, contrast-induced nephropathy, neurologic, spinal cord or cardiac complications, and/or use of advanced imaging to reduce radiation exposure during implantation of these devices. Participation in investigational device trials not encompassed by the IDE protocol should be 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. Participation in medical therapy trial or advanced imaging trial designed to improve peri-operative outcomes or to reduce radiation exposure of fenestrated-branched endografts may be concurrent with the IDE study. Examples include therapy directed to reduce rates of spinal cord injury, stroke and contrast-induced nephropathy associated with implantation of fenestrated-branched stent-grafts or advanced imaging trials designed to reduce radiation exposure during repair.
  • 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 zone for the investigational stent-graft, those who are deemed prohibitive risk for open surgical repair or connective tissue disorders with no effect of vascular system (e.g non-vascular forms of Ehlers Danlos).
  • 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 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 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) <8.0 mm with inability to perform open surgical conduit ; b. Iliac artery diameter, measured outer wall to outer wall on a sectional image (CT) >20 mm at distal fixation site, with inability to perform open internal iliac artery revascularization or iliac branch stent graft ; c. Non-aneurysmal external liac artery distal fixation site <10 mm in length ; d. Non-aneurysmal internal iliac artery main trunk or branch segment with length <10mm or with inner wall diameter <4 or >14mm; e. Unsuitable anatomy due to inability to preserve at least one hypogastric artery

Additional anatomical inclusion criteria for aortic arch devices:

  • 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 bypass grafts that are considered patent and necessary for proper cardiac perfusion
  • 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 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) common carotid 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: 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 graft) that is proximal to the primary dissection, such that a stent-graft would be anticipated to seal off the dissection lumen; c. 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; d. 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.

Sites / Locations

  • Mayo Clinic
  • The University of Texas Health Science Center at HoustonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Thoracoabdominal Aortic Aneurysm Arm

Aortic Arch Aneurysm Arm

Arm Description

The TAAA study arm will include patients treated by endovascular aortic repair of thoracoabdominal aortic aneurysms (Extent I to IV) using either an off-the-shelf Zenith t-Branch or patient-specific stent-graft with a combination of fenestrations and/or branches. The graft includes 1 to 5 small holes (fenestrations) or cuffs (side branches) . These small holes or branches are the investigational part of this research study. The arteries to the liver, intestine, and kidneys will be have a stent (small tubular stainless steel structures) to help keep the arteries open and aligned with the fenestrations or branches.

Aortic Arch study arm will include patients with aortic arch aneurysms treated by Patient-specific stent-grafts with one to three inner branches or a scallop. The study will include patients with thoracoabdominal and/or aortic arch aneurysms due to degenerative aneurysms or chronic aortic dissections. The stent-graft design for this study will be individually selected based on anatomy at the discretion of the principal investigator, including an off-the-shelf stent-graft (t-Branch stent-graft) or patient-specific stent-graft with a combination of fenestrations and/or branches.

Outcomes

Primary Outcome Measures

Number of subjects who have died at 30 days post treatment
Deaths 30 days after treatment
Number of subjects who experience a Major Adverse Event at 30 days post treatment
A Major Adverse Event includes any of the following: bowel ischemia, myocardial infarction (heart attack), paraplegia, renal failure, respiratory failure, stroke, or blood loss greater than 1000 ml.

Secondary Outcome Measures

Percentage of subjects who achieve treatment success
Treatment success is defined by a composite endpoint, which includes all the following criteria: 1) technical success, defined as successful delivery and deployment of the custom-made endovascular graft with preservation of those branch vessels intended to be preserved; 2) freedom from type I or III endoleak; 3) freedom from stent-graft migration; 4) freedom from aneurysm enlargement >5 mm; 5) freedom from aneurysm rupture or conversion to open repair.
Mean Quality of Life Measure at Various Time Points
Subjects complete the Short-Form General Health Survey (SF-36) form which consists of an 11 question survey that is divided into 2 parts: physical and emotional. The scale scores range from 0 to 100, with (0 = worst imaginable, 100 = best imaginable).

Full Information

First Posted
March 14, 2014
Last Updated
October 31, 2022
Sponsor
Gustavo Oderich
Collaborators
William Cook Australia
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1. Study Identification

Unique Protocol Identification Number
NCT02089607
Brief Title
Complex Abdominal, TAAA, Aortic Arch Aneurysm or Dissections With Fenestrated/Branched Stent Graft
Official Title
Clinical Outcomes and Quality of Life Measures in Patients Treated for Complex Abdominal, Thoracoabdominal and Aortic Arch Aneurysms or Dissections With Fenestrated and Branched Stent Grafts
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 2014 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
May 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gustavo Oderich
Collaborators
William Cook Australia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
This is a traditional device feasibility study intended to generate preliminary safety and efficacy information that may be used to plan an appropriate future study, or to inform further product development. Subjects will have been diagnosed with a bulge or aneurysm in their aortic arch and or abdominal aorta, which is the blood vessel in the abdomen (belly) that supplies blood to most of the lower body including major organs and the legs. The Zenith t-Branch and physician-specified fenestrated and branched endovascular graft is a tubular graft made of polyester fabric sewn to stainless steel stents that keep the graft open. As an aneurysm expands, the walls become weak and may rupture, causing a major loss of blood with a high risk of death and other serious complications. To avoid this risk the aneurysm will be repaired by putting a graft inside the aneurysm. The graft will be inserted through arteries in the groin (called endovascular repair). This procedure uses catheters that go inside the blood vessel to place a stent-graft above and below the aneurysm. The graft includes 1 to 5 small holes (fenestrations) or cuffs (side branches). These small holes or branches are the investigational part of this research study. The arteries to the liver, intestine, and kidneys will have a stent (small tubular stainless steel structures) to help keep the arteries open and aligned with the fenestrations or branches. The Zenith t-Branch and physician-specified fenestrated and branched endovascular graft will be referred to as the Zenith Fenestrated-Branched System.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complex Abdominal Aortic Aneurysm, Thoracoabdominal Aortic Aneurysm, Aortic Arch Aneurysm, Aortic Arch Dissection
Keywords
aneurysm, aortic aneurysm

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
530 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Thoracoabdominal Aortic Aneurysm Arm
Arm Type
Experimental
Arm Description
The TAAA study arm will include patients treated by endovascular aortic repair of thoracoabdominal aortic aneurysms (Extent I to IV) using either an off-the-shelf Zenith t-Branch or patient-specific stent-graft with a combination of fenestrations and/or branches. The graft includes 1 to 5 small holes (fenestrations) or cuffs (side branches) . These small holes or branches are the investigational part of this research study. The arteries to the liver, intestine, and kidneys will be have a stent (small tubular stainless steel structures) to help keep the arteries open and aligned with the fenestrations or branches.
Arm Title
Aortic Arch Aneurysm Arm
Arm Type
Experimental
Arm Description
Aortic Arch study arm will include patients with aortic arch aneurysms treated by Patient-specific stent-grafts with one to three inner branches or a scallop. The study will include patients with thoracoabdominal and/or aortic arch aneurysms due to degenerative aneurysms or chronic aortic dissections. The stent-graft design for this study will be individually selected based on anatomy at the discretion of the principal investigator, including an off-the-shelf stent-graft (t-Branch stent-graft) or patient-specific stent-graft with a combination of fenestrations and/or branches.
Intervention Type
Device
Intervention Name(s)
Thoracoabdominal Aortic Aneurysm Arm
Other Intervention Name(s)
Endovascular stent, Stent-graft
Intervention Description
The Zenith Fenestrated-Branched System is a tubular graft made of polyester fabric sewn to stainless steel stents that keep the graft open. The graft will be inserted through arteries in the leg (called endovascular repair). This procedure uses catheters that go inside the blood vessel to place a stent graft above and below the aneurysm. The graft includes 1 to 5 small holes (fenestrations) or cuffs (side branches). The arteries to the liver, intestine, and kidneys will be have a stent (small tubular stainless steel structures) to help keep the arteries open and aligned with the fenestrations or branches.
Intervention Type
Device
Intervention Name(s)
Aortic Arch Aneurysm Arm
Intervention Description
The endovascular graft includes the main aortic arch portion and one to three cuffs (side branches) that allow the graft to be located in the aortic arch. The number of cuffs is decided based on the anatomy of your aneurysm. The arteries in the aortic arch are the innominate artery (Zone 0), left common carotid artery (Zone 1) and the left subclavian artery (Zone 2). These arteries supply the right arm and right side of the brain, the left side of the brain and the left arm, respectively. The main aortic endovascular graft will be connected into the innominate artery, left common carotid artery and left subclavian artery using additional stents into the branch vessels.
Primary Outcome Measure Information:
Title
Number of subjects who have died at 30 days post treatment
Description
Deaths 30 days after treatment
Time Frame
30 days post treatment
Title
Number of subjects who experience a Major Adverse Event at 30 days post treatment
Description
A Major Adverse Event includes any of the following: bowel ischemia, myocardial infarction (heart attack), paraplegia, renal failure, respiratory failure, stroke, or blood loss greater than 1000 ml.
Time Frame
30 days post treatment
Secondary Outcome Measure Information:
Title
Percentage of subjects who achieve treatment success
Description
Treatment success is defined by a composite endpoint, which includes all the following criteria: 1) technical success, defined as successful delivery and deployment of the custom-made endovascular graft with preservation of those branch vessels intended to be preserved; 2) freedom from type I or III endoleak; 3) freedom from stent-graft migration; 4) freedom from aneurysm enlargement >5 mm; 5) freedom from aneurysm rupture or conversion to open repair.
Time Frame
12 months post treatment
Title
Mean Quality of Life Measure at Various Time Points
Description
Subjects complete the Short-Form General Health Survey (SF-36) form which consists of an 11 question survey that is divided into 2 parts: physical and emotional. The scale scores range from 0 to 100, with (0 = worst imaginable, 100 = best imaginable).
Time Frame
Pre-procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. 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 zone proximal to iliac bifurcation. 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, elephant trunk repair), 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, percutaneous aortic valve protocol, or concomitant clinical trials designed to evaluate medical therapy strategies to reduce perioperative risk during fenestrated-branched endovascular repair, including risks of renal dysfunction, contrast-induced nephropathy, neurologic, spinal cord or cardiac complications, and/or use of advanced imaging to reduce radiation exposure during implantation of these devices. Participation in investigational device trials not encompassed by the IDE protocol should be 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. Participation in medical therapy trial or advanced imaging trial designed to improve peri-operative outcomes or to reduce radiation exposure of fenestrated-branched endografts may be concurrent with the IDE study. Examples include therapy directed to reduce rates of spinal cord injury, stroke and contrast-induced nephropathy associated with implantation of fenestrated-branched stent-grafts or advanced imaging trials designed to reduce radiation exposure during repair. 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 zone for the investigational stent-graft, those who are deemed prohibitive risk for open surgical repair or connective tissue disorders with no effect of vascular system (e.g non-vascular forms of Ehlers Danlos). 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 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 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) <8.0 mm with inability to perform open surgical conduit ; b. Iliac artery diameter, measured outer wall to outer wall on a sectional image (CT) >20 mm at distal fixation site, with inability to perform open internal iliac artery revascularization or iliac branch stent graft ; c. Non-aneurysmal external liac artery distal fixation site <10 mm in length ; d. Non-aneurysmal internal iliac artery main trunk or branch segment with length <10mm or with inner wall diameter <4 or >14mm; e. Unsuitable anatomy due to inability to preserve at least one hypogastric artery Additional anatomical inclusion criteria for aortic arch devices: 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 bypass grafts that are considered patent and necessary for proper cardiac perfusion 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 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) common carotid 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: 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 graft) that is proximal to the primary dissection, such that a stent-graft would be anticipated to seal off the dissection lumen; c. 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; d. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aidin Baghbanioskouei, MD
Phone
(713) 486-5361
Email
Aidin.Baghbanioskouei@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gustavo S. Oderich, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aidin Baghbanioskouei, MD
Phone
713-486-5361
Email
Aidin.Baghbanioskouei@uth.tmc.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35181519
Citation
Chait J, Tenorio ER, Mendes BC, Barbosa Lima GB, Marcondes GB, Wong J, Macedo TA, De Martino RR, Oderich GS. Impact of gap distance between fenestration and aortic wall on target artery instability following fenestrated-branched endovascular aortic repair. J Vasc Surg. 2022 Jul;76(1):79-87.e4. doi: 10.1016/j.jvs.2022.01.135. Epub 2022 Feb 16.
Results Reference
derived
PubMed Identifier
34132698
Citation
Oderich GS, Tenorio ER, Mendes BC, Lima GBB, Marcondes GB, Saqib N, Hofer J, Wong J, Macedo TA. Midterm Outcomes of a Prospective, Nonrandomized Study to Evaluate Endovascular Repair of Complex Aortic Aneurysms Using Fenestrated-Branched Endografts. Ann Surg. 2021 Sep 1;274(3):491-499. doi: 10.1097/SLA.0000000000004982.
Results Reference
derived
PubMed Identifier
31611106
Citation
Tenorio ER, Karkkainen JM, Mendes BC, DeMartino RR, Macedo TA, Diderrich A, Hofer J, Oderich GS. Outcomes of directional branches using self-expandable or balloon-expandable stent grafts during endovascular repair of thoracoabdominal aortic aneurysms. J Vasc Surg. 2020 May;71(5):1489-1502.e6. doi: 10.1016/j.jvs.2019.07.079. Epub 2019 Oct 11.
Results Reference
derived
PubMed Identifier
30714570
Citation
Karkkainen JM, Sandri GA, Tenorio ER, Macedo TA, Hofer J, Gloviczki P, Cha S, Oderich GS. Prospective assessment of health-related quality of life after endovascular repair of pararenal and thoracoabdominal aortic aneurysms using fenestrated-branched endografts. J Vasc Surg. 2019 May;69(5):1356-1366.e6. doi: 10.1016/j.jvs.2018.07.060. Epub 2018 Oct 24.
Results Reference
derived
PubMed Identifier
26372191
Citation
de Souza LR, Oderich GS, Banga PV, Hofer JM, Wigham JR, Cha S, Gloviczki P. Outcomes of total percutaneous endovascular aortic repair for thoracic, fenestrated, and branched endografts. J Vasc Surg. 2015 Dec;62(6):1442-9.e3. doi: 10.1016/j.jvs.2015.07.072. Epub 2015 Sep 12.
Results Reference
derived

Learn more about this trial

Complex Abdominal, TAAA, Aortic Arch Aneurysm or Dissections With Fenestrated/Branched Stent Graft

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