Visceral Manifold Study for the Repair of Thoracoabdominal Aortic Aneurysms

NCT03113383 | Terminated Results DMC FDA Device

• 1 other identifier: 161627
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the clinical investigation is to assess the use of the the Visceral Manifold Thoracoabdominal Aortic Aneurysms (VTAAA) stent graft system to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy. The primary intent of the study is to assess safety (i.e. freedom from major adverse events (MAE) at 30 days) and preliminary effectiveness (i.e., treatment success and technical success) of the device (i.e., the proportion of treatment group subjects that achieve and maintain treatment success at one year).

Conditions

Thoracoabdominal Aortic Aneurysm

Keywords

Thoracoabdominal Aortic Aneurysm; Endovascular Aneurysm Repair; Stent-Graft

Outcome Measures

Primary Outcomes (2)

• Safety Endpoint: Freedom From Major Adverse Events

  Freedom from major adverse events (MAE) at 30 days.

  30 days

• Preliminary Effectiveness

  Proportion of subjects treated with the device that achieve and maintain treatment success at 1 year.

  1 year

Secondary Outcomes (12)

• Secondary Safety Endpoint:Freedom From Major Adverse Events

  6 months

• Secondary Safety Endpoint: Freedom From Major Adverse Events

  1 year.

• Secondary Safety Endpoint: Freedom From Major Adverse Events

  2 years.

• Secondary Safety Endpoint: Freedom From Major Adverse Events

  3 years.

• Secondary Safety Endpoint: Freedom From Major Adverse Events

  4 years.

Study Arms (2)

Primary Arm

EXPERIMENTAL

Use of the thoracic bifurcation and the visceral manifold to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy.

Device: Thoracoabdominal Aortic Aneurysm Repair

Expanded Selection Arm

EXPERIMENTAL

Use of the thoracic bifurcation and the visceral manifold to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy.

Device: Thoracoabdominal Aortic Aneurysm Repair

Interventions

Thoracoabdominal Aortic Aneurysm Repair DEVICE

Thoracoabdominal aortic aneurysm repair

Expanded Selection Arm; Primary Arm

Eligibility Criteria

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

You may qualify if:

• A patient may be entered into the study if the patient has at least one of the following:
• An aneurysm with a maximum diameter of greater than or equal to 5.5 cm or 2 times the normal diameter just proximal to the aneurysm using orthogonal (i.e., perpendicular to the centerline) measurements
• Aneurysm with a history of growth greater than or equal to 0.5 cm in 6 months
• Saccular aneurysm deemed at significant risk for rupture
• Symptomatic aneurysm greater than 4.5 cm
• Axillary or brachial and iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices or accessories, with or without use of a surgical conduit
• Proximal landing zone for the thoracic bifurcation stent graft that has:
• Greater than or equal to 2.5 cm of nonaneurysmal aortic segment including previously placed graft material (neck) distal to the left subclavian artery (LSA) diameter in the range of 26-42 mm
• Adequate distance from the celiac artery, in order to accommodate cannulation from the antegrade access point when considering the total deployed length of the thoracic bifurcation and visceral manifold
• Minimum branch vessel diameter greater than 5 mm
• Iliac artery or aortic distal fixation site, including both native tissue and previously placed graft, greater than or equal to 15 mm in length and diameter in the range of 8 - 25 mm
• Age: greater than or equal to 18 years old
• Life expectancy: greater than 1 year

You may not qualify if:

• Patient is a good candidate for and elects for open surgical repair
• Can be treated in accordance with the instructions for use with a legally marketed endovascular device
• Is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site
• Unwilling to comply with the follow-up schedule
• Inability or refusal to give informed consent
• Urgent or emergent presentation
• Patient is pregnant or breastfeeding
• Patient has a contained rupture
• Patient has a ruptured aneurysm
• Patient has a dissection in the portion of the aorta intended to be treated
• Obstructive stenting of any or all of the visceral vessels
• Poor performance status including two major system failures (including but not limited to cardiovascular, pulmonary, renal, hepatobiliary, and neuromuscular)
• Known sensitivities or allergies to the materials of construction of the devices, including nitinol (Nickel: Titanium) polyester, platinum-iridium, polytetrafluoroethylene (PTFE), platinum, gold, polyethylene, or stainless steel.
• Known hypersensitivity or contraindication to anticoagulation or contrast media that cannot be adequately medically managed
• Uncorrectable coagulopathy

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• Medtronic: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Aortic Aneurysm, Thoracoabdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm, Abdominal; Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Results Point of Contact

• Title: Thomas C Naslund, MD
• Organization: Vanderbilt University Medical Center

thomas.naslund@vumc.org

5-322-2343

Study Officials

• Thomas C Naslund, MD

  Chief, Division of Vascular Surgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: April 10, 2017
• First Posted: April 13, 2017
• Study Start: August 18, 2017
• Primary Completion: March 2, 2018
• Study Completion: October 6, 2021
• Last Updated: November 8, 2022
• Results First Posted: February 10, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Upon completion of the study
• Access Criteria: Pooled data will be shared with other investigators evaluating the same device and endpoints.

Locations

US (1)