Safety and Effectiveness of Physician-Modified Fenestrated and Branched Aortic Endografting for the Treatment of Thoracoabdominal Aortic Aneurysms (TAAA)
Overview
- Phase
- Not Applicable
- Intervention
- Physician-modified aortic endograft
- Conditions
- Aortic Aneurysm, Thoracoabdominal
- Sponsor
- Yale University
- Enrollment
- 80
- Locations
- 3
- Primary Endpoint
- Major Adverse Events (MAE) at 30 days following surgery
- Status
- Recruiting
- Last Updated
- 5 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. 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. This record was transferred to Yale in October 2024.
Investigators
David Kuwayama
Associate Professor of Surgery
Yale University
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 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.
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 - 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.
Intervention: Physician-modified aortic endograft
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.
Intervention: Physician-modified aortic endograft
Outcomes
Primary Outcomes
Major Adverse Events (MAE) at 30 days following surgery
Time Frame: 30 Days
Percent of patients who development major adverse events
Treatment success at 12 months following surgery
Time Frame: 12 Months
Percent of patients achieving treatment success through 1 year
30 day survival
Time Frame: 30 Days
Percent of patients who survive 30 days following surgery
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
- Treatment success(At 30, 183 days; 2, 3, 4 and 5 years)
- Conversion to open repair(Day of Surgery)
- Technical success on the day of surgery(Day of Surgery)
- Paraplegia(Day of Surgery)
- Survival rate(At 30, 183 days; 1, 2, 3, 4 and 5 years)
- Lower extremity ischemia(Day of Surgery)
- Paraparesis(Day of Surgery)
- Major Adverse Events (MAEs)(At 30, 183 days; 1, 2, 3, 4 and 5 years)
- Aneurysm rupture(Day of Surgery)
- Access site complication (Femoral or Iliac)(Day of Surgery)
- Lower extremity compartment syndrome(Day of Surgery)
- Stroke(Day of Surgery)
- Death during surgery(Day of Surgery)