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Physician-Modified Fenestrated and Branched Aortic Endografting for TAAA

Primary Purpose

Aortic Aneurysm, Thoracoabdominal

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physician-modified aortic endograft
Sponsored by
David P. Kuwayama
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Aneurysm, Thoracoabdominal focused on measuring endovascular, physician-modified, graft, fenestration

Eligibility Criteria

50 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

MAIN ARM - Inclusion Criteria:

  1. Must be a man or woman 50 years of age or older by the date of informed consent.
  2. Must have a thoracoabdominal aortic aneurysm of any Crawford classification (extent I-V) that extends no more proximal than the left subclavian artery.
  3. 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).
  4. Must be considered, in the judgment of the S-I, to be a high risk candidate for open surgical repair.
  5. Must not be a candidate for repair under the Instructions for Use of a commercially available, FDA-approved endovascular graft.
  6. Must be able to provide informed consent.
  7. Must be able to comply with the five year study assessment schedule of events.
  8. Must have a non-aneurysm-related life expectancy, in the judgment of the S-I, of greater than 2 years.

MAIN ARM - Exclusion Criteria:

  1. Aneurysm due to acute or chronic dissection, intramural hematoma, penetrating aortic ulceration, pseudoaneurysm, mycotic aneurysm, or traumatic transection.
  2. Ruptured or acutely symptomatic aortic aneurysm.
  3. Known connective tissue disorder.
  4. 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) < 5 mm or > 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.
  5. Known sensitivities or allergies to stainless steel, PTFE, polyester, polypropylene, nitinol, or gold.
  6. History of anaphylaxis to contrast, with inability to prophylax appropriately.
  7. Have uncorrectable coagulopathy.
  8. Have unstable angina.
  9. Have a body habitus that would inhibit X-ray visualization of the aorta.
  10. Have a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned ≤30 days of the endovascular repair.
  11. Known to be participating in any other clinical study which may affect performance of this device.
  12. Known, visible, or suspected pregnancy, confirmed with a Urine Pregnancy Test (UPT)
  13. Contraindication to oral antiplatelet therapy.
  14. Prisoners or those on alternative sentencing.
  15. Known systemic infection with potential for endovascular graft infection.
  16. Anticipated need for MRI scanning within 3 months of insertion of investigational product.
  17. Other conditions or comorbidities that, in the opinion of the S-I, would exclude the patient.

EXPANDED ACCESS ARM - Inclusion Criteria

  1. Must be a man or woman 50 years of age or older by the date of informed consent
  2. 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.
  3. 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 judgment of the S-I, has aneurysm characteristics that portend a high risk of near-term rupture
  4. Must be considered, in the judgement of the S-I, to be a high risk candidate for open surgical repair
  5. Must not be a candidate for repair under the Instructions for Use of a commercially available, FDA-approved endovascular graft
  6. Patient must be able to provide informed consent
  7. Must be able to comply with the five year study assessment schedule of events
  8. 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

  1. Known or suspected mycotic aneurysm
  2. Ruptured aneurysm with hemodynamic instability
  3. Known connective tissue disorder
  4. 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
  5. Known sensitivities or allergies to stainless steel, PTFE, polyester, polypropylene, nitinol, or gold
  6. History of anaphylaxis to contrast, with inability to prophylax appropriately.
  7. Have uncorrectable coagulopathy
  8. Have a body habitus that would inhibit X-ray visualization of the aorta
  9. Have a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned ≤ 30 days of the endovascular repair
  10. Known to be participating in any other clinical study which may affect performance of this device
  11. Known, visible, or suspected pregnancy, confirmed with a Urine Pregnancy Test (UPT)
  12. Contraindication to oral antiplatelet therapy
  13. Prisoners or those on alternative sentencing
  14. Known systemic infection with potential for endovascular graft infection
  15. Anticipated need for MRI scanning within 3 months of insertion of investigational product
  16. Other conditions or comorbidities that, in the opinion of the S-I, would exclude the patient

Sites / Locations

  • Dartmouth-Hitchcock Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Main Arm - Physician-modified fenestrated endovascular graft

Expanded Access Arm - Physician-modified fenestrated endovascular graft.

Arm Description

Use of a physician-modified fenestrated Cook Zenith Alpha Thoracic Endovascular Graft for the endovascular treatment of asymptomatic, non-ruptured thoracoabdominal aortic aneurysms of any Crawford extent (I-V) meeting traditional size criteria for open surgical repair.

Use of a physician-modified fenestrated Cook Zenith Alpha Thoracic Endovascular Graft for the endovascular treatment of asymptomatic, non-ruptured thoracoabdominal, thoracic, or abdominal aortic aneurysms of any Crawford extent (I-V) meeting traditional size criteria for open surgical repair in an expanded use population.

Outcomes

Primary Outcome Measures

30 day survival
Percent of patients who survive 30 days following surgery
Major Adverse Events (MAE) at 30 days following surgery
Percent of patients who development major adverse events
Treatment success at 12 months following surgery
Percent of patients achieving treatment success through 1 year
Technical success at 12 months following surgery
Technical success is assessed 12 months following surgery and is defined as a composite of: successful delivery, without need for unanticipated corrective intervention related to delivery; successful and accurate deployment at the intended implantation site; and successful withdrawal, without need for unanticipated correct intervention related to withdrawal.

Secondary Outcome Measures

Technical success on the day of surgery
Percent of patients achieving technical success on the day of surgery, defined as the composite of; successful delivery, successful and accurate deployment, successful withdrawal.
Aneurysm rupture
Percent of patients developing aneurysm rupture
Conversion to open repair
Percent of patients necessitating conversion to open repair. This is assessed intraoperatively. In case of a device deployment failure or intraoperative aneurysm rupture, emergent conversion to open repair via laparotomy, thoracotomy, or thoracoabdominal aortic exposure may become necessary. Patients undergoing such intraoperative conversion will be considered to have met this endpoint.
Access site complication (Femoral or Iliac)
Percent of patients suffering access site complication (femoral or iliac). If femoral or iliac rupture occurs intraoperatively, or if femoral or iliac flow-limiting dissection or occlusion is identified intraoperatively or on the day of surgery, patients will be considered to have met this outcome.
Lower extremity ischemia
Percent of patients developing lower extremity ischemia. This will be assess intraoperatively and on the day of surgery. If patients have lower extremity pulses either absent or diminished compared to baseline, with associated pain, sensory deficits or motor deficits on clinical evaluation, patients will be considered to have met this outcome.
Lower extremity compartment syndrome
Percent of patients developing lower extremity compartment syndrome. In patients with lower extremity pain to passive motion post-operatively, invasive pressure measurement of the four calf compartments will be performed. If compartment pressures are greater than 30 in any compartment, patients will be considered to have met this outcome.
Stroke
Percent of patients developing stroke - Modified Rankin Score (MRS) of 2 or greater). In patients with altered mental status or lateralizing motor or sensory deficits, MRI of the brain will be performed. If diffusion weighted MRI imaging demonstrates an intracranial lesion, a modified Rankin score will be calculated. If MRS is 2 or greater, patients will be considered to have met this outcome.
Paraplegia
Percent of patients developing paraplegia. Patients with complete absence of lower extremity motor function in one or both legs will be considered to have met this outcome.
Paraparesis
Percent of patients developing paraparesis. Patients will undergo lower extremity motor strength assessment post-operatively on a standard 0 to 5 scale. If greater than 0 but less than 5 in either extremity, patients will be considered to have met this outcome.
Death during surgery
Percent of patients who die during surgery
Survival rate
Percent of patients who survive
Major Adverse Events (MAEs)
Percent of patients that development MAEs
Treatment success
Percent of patients achieving treatment success

Full Information

First Posted
December 5, 2016
Last Updated
March 13, 2023
Sponsor
David P. Kuwayama
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1. Study Identification

Unique Protocol Identification Number
NCT02989948
Brief Title
Physician-Modified Fenestrated and Branched Aortic Endografting for TAAA
Official Title
Safety and Effectiveness of Physician-Modified Fenestrated and Branched Aortic Endografting for the Treatment of Thoracoabdominal Aortic Aneurysms (TAAA)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 22, 2020 (Actual)
Primary Completion Date
February 21, 2023 (Actual)
Study Completion Date
September 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
David P. Kuwayama

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
This study is a prospective, two-arm, traditional feasibility study of a physician modified fenestrated Cook Zenith Alpha Thoracic Endovascular Graft base device in adult patients meeting traditional size criteria for open surgical treatment of thoracoabdominal aortic aneurysms (TAAAs). Patients meriting surgical treatment of their aneurysm that also meet inclusion and exclusion criteria will be eligible for enrollment. Patients will be followed for 5 years post procedure. Major adverse events (MAEs) will also be recorded by the Sponsor-Investigator (S-I) and will be monitored by a locally appointed Data Monitoring Committee, Dartmouth-Hitchcock Health and the D-HH Human Research Protection Program IRB/IEC, and the FDA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Aneurysm, Thoracoabdominal
Keywords
endovascular, physician-modified, graft, fenestration

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Main Arm - Physician-modified fenestrated endovascular graft
Arm Type
Experimental
Arm Description
Use of a physician-modified fenestrated Cook Zenith Alpha Thoracic Endovascular Graft for the endovascular treatment of asymptomatic, non-ruptured thoracoabdominal aortic aneurysms of any Crawford extent (I-V) meeting traditional size criteria for open surgical repair.
Arm Title
Expanded Access Arm - Physician-modified fenestrated endovascular graft.
Arm Type
Experimental
Arm Description
Use of a physician-modified fenestrated Cook Zenith Alpha Thoracic Endovascular Graft for the endovascular treatment of asymptomatic, non-ruptured thoracoabdominal, thoracic, or abdominal aortic aneurysms of any Crawford extent (I-V) meeting traditional size criteria for open surgical repair in an expanded use population.
Intervention Type
Device
Intervention Name(s)
Physician-modified aortic endograft
Intervention Description
Use of physician-modified fenestrated Cook Zenith Alpha Thoracic Endovascular Graft for the endovascular treatment of asymptomatic, non-ruptured thoracoabdominal aortic aneurysms of any Crawford extent (I-V) meeting traditional size criteria for open surgical repair.
Primary Outcome Measure Information:
Title
30 day survival
Description
Percent of patients who survive 30 days following surgery
Time Frame
30 Days
Title
Major Adverse Events (MAE) at 30 days following surgery
Description
Percent of patients who development major adverse events
Time Frame
30 Days
Title
Treatment success at 12 months following surgery
Description
Percent of patients achieving treatment success through 1 year
Time Frame
12 Months
Title
Technical success at 12 months following surgery
Description
Technical success is assessed 12 months following surgery and is defined as a composite of: successful delivery, without need for unanticipated corrective intervention related to delivery; successful and accurate deployment at the intended implantation site; and successful withdrawal, without need for unanticipated correct intervention related to withdrawal.
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Technical success on the day of surgery
Description
Percent of patients achieving technical success on the day of surgery, defined as the composite of; successful delivery, successful and accurate deployment, successful withdrawal.
Time Frame
Day of Surgery
Title
Aneurysm rupture
Description
Percent of patients developing aneurysm rupture
Time Frame
Day of Surgery
Title
Conversion to open repair
Description
Percent of patients necessitating conversion to open repair. This is assessed intraoperatively. In case of a device deployment failure or intraoperative aneurysm rupture, emergent conversion to open repair via laparotomy, thoracotomy, or thoracoabdominal aortic exposure may become necessary. Patients undergoing such intraoperative conversion will be considered to have met this endpoint.
Time Frame
Day of Surgery
Title
Access site complication (Femoral or Iliac)
Description
Percent of patients suffering access site complication (femoral or iliac). If femoral or iliac rupture occurs intraoperatively, or if femoral or iliac flow-limiting dissection or occlusion is identified intraoperatively or on the day of surgery, patients will be considered to have met this outcome.
Time Frame
Day of Surgery
Title
Lower extremity ischemia
Description
Percent of patients developing lower extremity ischemia. This will be assess intraoperatively and on the day of surgery. If patients have lower extremity pulses either absent or diminished compared to baseline, with associated pain, sensory deficits or motor deficits on clinical evaluation, patients will be considered to have met this outcome.
Time Frame
Day of Surgery
Title
Lower extremity compartment syndrome
Description
Percent of patients developing lower extremity compartment syndrome. In patients with lower extremity pain to passive motion post-operatively, invasive pressure measurement of the four calf compartments will be performed. If compartment pressures are greater than 30 in any compartment, patients will be considered to have met this outcome.
Time Frame
Day of Surgery
Title
Stroke
Description
Percent of patients developing stroke - Modified Rankin Score (MRS) of 2 or greater). In patients with altered mental status or lateralizing motor or sensory deficits, MRI of the brain will be performed. If diffusion weighted MRI imaging demonstrates an intracranial lesion, a modified Rankin score will be calculated. If MRS is 2 or greater, patients will be considered to have met this outcome.
Time Frame
Day of Surgery
Title
Paraplegia
Description
Percent of patients developing paraplegia. Patients with complete absence of lower extremity motor function in one or both legs will be considered to have met this outcome.
Time Frame
Day of Surgery
Title
Paraparesis
Description
Percent of patients developing paraparesis. Patients will undergo lower extremity motor strength assessment post-operatively on a standard 0 to 5 scale. If greater than 0 but less than 5 in either extremity, patients will be considered to have met this outcome.
Time Frame
Day of Surgery
Title
Death during surgery
Description
Percent of patients who die during surgery
Time Frame
Day of Surgery
Title
Survival rate
Description
Percent of patients who survive
Time Frame
At 30, 183 days; 1, 2, 3, 4 and 5 years
Title
Major Adverse Events (MAEs)
Description
Percent of patients that development MAEs
Time Frame
At 30, 183 days; 1, 2, 3, 4 and 5 years
Title
Treatment success
Description
Percent of patients achieving treatment success
Time Frame
At 30, 183 days; 2, 3, 4 and 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
MAIN ARM - Inclusion Criteria: 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 - Exclusion Criteria: 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) < 5 mm or > 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 interventional 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 judgment of the S-I, has aneurysm characteristics that portend a high risk of near-term rupture 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 interventional 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David P. Kuwayama, M.D., M.P.A.
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share individual participant data (IPD) exists at this time.
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Physician-Modified Fenestrated and Branched Aortic Endografting for TAAA

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