Physician-Modified Fenestrated and Branched Aortic Endografting for TAAA

Sponsor

David P. Kuwayama (Other)

Overall Status

Recruiting

CT.gov ID

NCT02989948

Collaborator

(none)

Enrollment

Location

Arms

112.3

Anticipated Duration (Months)

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Aortic Aneurysm, Thoracoabdominal	Device: Physician-modified aortic endograft	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Safety and Effectiveness of Physician-Modified Fenestrated and Branched Aortic Endografting for the Treatment of Thoracoabdominal Aortic Aneurysms (TAAA)

Actual Study Start Date :

Apr 22, 2020

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Sep 1, 2029

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Main Arm - Physician-modified fenestrated endovascular graft 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.	Device: Physician-modified aortic endograft 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.
Experimental: Expanded Access Arm - Physician-modified fenestrated endovascular graft. 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.	Device: Physician-modified aortic endograft 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.

Arm

Intervention/Treatment

Experimental: Main Arm - Physician-modified fenestrated endovascular graft

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.

Device: Physician-modified aortic endograft

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.

Experimental: Expanded Access Arm - Physician-modified fenestrated endovascular graft.

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.

Device: Physician-modified aortic endograft

Outcome Measures

Primary Outcome Measures

30 day survival [30 Days]
Percent of patients who survive 30 days following surgery
Major Adverse Events (MAE) at 30 days following surgery [30 Days]
Percent of patients who development major adverse events
Treatment success at 12 months following surgery [12 Months]
Percent of patients achieving treatment success through 1 year
Technical success at 12 months following surgery [12 Months]
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 [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 [Day of Surgery]
Percent of patients developing aneurysm rupture
Conversion to open repair [Day of Surgery]
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) [Day of Surgery]
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 [Day of Surgery]
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 [Day of Surgery]
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 [Day of Surgery]
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 [Day of Surgery]
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 [Day of Surgery]
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 [Day of Surgery]
Percent of patients who die during surgery
Survival rate [At 30, 183 days; 1, 2, 3, 4 and 5 years]
Percent of patients who survive
Major Adverse Events (MAEs) [At 30, 183 days; 1, 2, 3, 4 and 5 years]
Percent of patients that development MAEs
Treatment success [At 30, 183 days; 2, 3, 4 and 5 years]
Percent of patients achieving treatment success

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 95 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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