Safety and Effectiveness of Physician-Modified Fenestrated and Branched Aortic Endografting for the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms
Overview
- Phase
- Not Applicable
- Intervention
- Physician-modified aortic endograft
- Conditions
- Aortic Aneurysm
- Sponsor
- Bjoern D. Suckow
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- 30 day survival
- Status
- Recruiting
- Last Updated
- 17 days ago
Overview
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.
Investigators
Bjoern D. Suckow
Associate Professor of Vascular Surgery
Dartmouth-Hitchcock Medical Center
Eligibility Criteria
Inclusion 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 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.
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
Arms & Interventions
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.
Intervention: Physician-modified aortic endograft
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.
Intervention: Physician-modified aortic endograft
Outcomes
Primary Outcomes
30 day survival
Time Frame: 30 days
Percent of patients who survive 30 days following surgery
Major Adverse Events (MAE) at 30 days following surgery
Time Frame: 30 days
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
Treatment success at 12 months following surgery
Time Frame: 12 months
Percent of patients achieving treatment success through 1 year.
Technical success at 12 months following surgery
Time Frame: 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 Outcomes
- Aneurysm rupture(Day of Surgery)
- Conversion to open repair(Day of Surgery)
- Paraparesis(Day of Surgery)
- Death during surgery(Day of Surgery)
- Major Adverse Events (MAEs)(At 30, 183 days; 1, 2, 3, 4 and 5 years)
- Treatment success(At 30, 183 days; 2, 3, 4 and 5 years)
- Technical success on the day of surgery(Day of Surgery)
- Lower extremity ischemia(Day of Surgery)
- Stroke(Day of Surgery)
- Paraplegia(Day of Surgery)
- Lower extremity compartment syndrome(Day of Surgery)
- Access site complication (Femoral or Iliac)(Day of Surgery)
- Survival rate(At 30, 183 days; 1, 2, 3, 4 and 5 years)
- Aneurysm-Specific Quality of Life Survey(At Screening, 30, 183 days; 2, 3, 4 and 5 years)