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

NCT06501872 | Recruiting DMC FDA Device

• 1 other identifier: STUDY02002274
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Aneurysm

Keywords

Aortic Aneurysm

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (14)

• Technical success on the day of surgery

  Day of Surgery

• Aneurysm rupture

  Day of Surgery

• Conversion to open repair

  Day of Surgery

• Access site complication (Femoral or Iliac)

  Day of Surgery

• Lower extremity ischemia

  Day of Surgery

Study Arms (2)

Main Arm

EXPERIMENTAL

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

Expanded Access Arm

EXPERIMENTAL

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

Interventions

Physician-modified aortic endograft DEVICE

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.

Expanded Access Arm; Main Arm

Eligibility Criteria

• Age: 50 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bjoern D. Suckow: lead

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

RECRUITING

MeSH Terms

Conditions

Aortic Aneurysm

Condition Hierarchy (Ancestors)

Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Bjoern D Suckow, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amirsadreddin Kazzazi

CONTACT

603-650-6379; Amirsadreddin.Kazzazi@hitchcock.org

Caren Saunders

CONTACT

6033-650-7985; caren.h.saunders@hitchcock.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Vascular Surgery

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 15, 2024
• Study Start: December 10, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2031
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)