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

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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Aneurysm
• Intervention / Treatment: Device: Physician-modified aortic endograft

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amirsadreddin Kazzazi; Phone Number: 603-650-6379; Email: Amirsadreddin.Kazzazi@hitchcock.org
• Study Contact Backup: Name: Caren Saunders; Phone Number: 6033-650-7985; Email: caren.h.saunders@hitchcock.org

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Recruiting
      • Dartmouth-Hitchcock Medical Center
      • Principal Investigator: Bjoern D Suckow, MD
      • Contact: Delaney Gray; Phone Number: 603-650-6228; Email: Delaney.V.Gray@hitchcock.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 judgement of the Investigator, to be a high- risk candidate for open surgical repair
• Must commit to comply with the five-year study assessment schedule of events
• Must have a non-aneurysm-related life expectancy, in the judgement of the Investigator, of greater than 2 years

Expanded Selection 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. The aneurysm must not extend proximal to the left subclavian artery, or, in the setting of more proximal disease, that disease must have been previously treated.
• 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 Investigator, has aneurysm characteristics that portend a high risk of near-term rupture

• 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
• Must be considered, in the judgement of the Investigator, to be a high-risk candidate for open surgical repair
• Patient must be able to provide informed consent
• Must commit to comply with the five-year study assessment schedule of events
• Must have a non-aneurysm-related life expectancy, in the judgement of the Investigator, 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 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 - Ability to bear children
• 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
• Candidate for repair under the Instructions for Use of a commercially available, FDA-approved endovascular graft
• Can enroll in a manufacturer-sponsored clinical study at our institution or is willing and eligible to participate in a study with a manufacturer-made device at another institution.

Expanded Selection 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 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
• Ability to bear children
• 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
• Candidate for repair under the Instructions for Use of a commercially available, FDA- approved endovascular graft
• Can enroll in a manufacturer-sponsored clinical study at our institution or is willing and eligible to participate in a study with a manufacturer-made device at another institution
• Other conditions or comorbidities that, in the opinion of the Investigator, would exclude the patient

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Main Arm; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30 day survival	Percent of patients who survive 30 days following surgery	30 days
Major Adverse Events (MAE) at 30 days following surgery	Percent of patients who development major adverse events at 30-days following surgery including the following: All-cause mortality; Loss of major organ or system function; Renal failure necessitating hemodialysis; Small or large bowel ischemia necessitating surgical or endovascular intervention; Hepatic ischemia necessitating surgical or endovascular intervention; Gastric ischemia necessitating surgical or endovascular intervention; Paraparesis; Paraplegia; Stroke (Modified Rankin Score of 2 or greater); Myocardial infarction; Ventilator dependence > 72 hours; Lower extremity ischemia necessitating surgical or endovascular intervention; Need for surgical or endovascular reintervention	30 days
Treatment success at 12 months following surgery	Percent of patients achieving treatment success through 1 year.	12 months
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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day of Surgery
Aneurysm rupture	Percent of patients developing aneurysm rupture	Day of Surgery
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.	Day of Surgery
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.	Day of Surgery
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.	Day of Surgery
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.	Day of Surgery
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.	Day of Surgery
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.	Day of Surgery
Death during surgery	Percent of patients who die during surgery	Day of Surgery
Survival rate	Percent of patients who survive	At 30, 183 days; 1, 2, 3, 4 and 5 years
Major Adverse Events (MAEs)	Percent of patients that development MAEs	At 30, 183 days; 1, 2, 3, 4 and 5 years
Treatment success	Percent of patients achieving treatment success	At 30, 183 days; 2, 3, 4 and 5 years
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	Day of Surgery
Aneurysm-Specific Quality of Life Survey	Assessment of quality of life using a validated disease-specific AAA survey. It will be measured using this survey.	At Screening, 30, 183 days; 2, 3, 4 and 5 years

Collaborators and Investigators

• Sponsor: Bjoern D. Suckow
• Investigators: Principal Investigator: Bjoern D Suckow, MD, Dartmouth-Hitchcock Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2031

Study Registration Dates

• First Submitted: July 8, 2024
• First Submitted That Met QC Criteria: July 8, 2024
• First Posted (Actual): July 15, 2024

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Aortic Aneurysm
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm
• Other Study ID Numbers: STUDY02002274

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share individual participant data (IPD) exists at this time.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No