Repair of Thoracoabdominal Aortic Aneurysms

NCT03111459 | Recruiting DMC FDA Device

• 1 other identifier: ISR-2016-10790
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the clinical investigation is to assess the use of the Medtronic Valiant Thoracoabdominal Stent Graft System to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy. The primary intent of the study is to assess safety and preliminary effectiveness of the device. Additionally, the study will assess technical success and treatment success at each follow-up interval.

Conditions

Thoracoabdominal Aneurysm

Keywords

endograft repair,

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects free from major adverse events

  major adverse events include death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, and stroke.

  30 days

Secondary Outcomes (1)

• Treatment Success at follow-up intervals

  1 month, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years

Study Arms (2)

Primary Study Arm

EXPERIMENTAL

Patients meeting primary inclusion/exclusion criteria will be enrolled in this arm and treated with the Medtronic Valiant Thoracoabdominal Stent Graft System.

Device: Medtronic Valiant Thoracoabdominal Stent Graft System

Expanded Selection Arm

EXPERIMENTAL

Patients who fail to meet the inclusion criteria of the Primary Study Arm may be enrolled under the Expanded Selection Arm and be treated with the Medtronic Valiant Thoracoabdominal Stent Graft System.

Device: Medtronic Valiant Thoracoabdominal Stent Graft System

Interventions

Medtronic Valiant Thoracoabdominal Stent Graft System DEVICE

The Medtronic Valiant Thoracoabdominal Stent Graft System is made up of two main body components and makes use of several off-the-shelf FDA-approved stent graft components The system is comprised of two investigational devices that include the thoracic bifurcation and the visceral manifold. The thoracic bifurcation is deployed in the thoracic aorta and provides the proximal seal for the device. The two limbs of the thoracic bifurcation allows for continued aortic flow while deploying the visceral segment. The visceral manifold is deployed within the larger 20 mm limb of the thoracic bifurcation to set the stage for the visceral debranching. The branches of the visceral manifold extend to the visceral vessel with the use of covered bridging stents and provide distal seal of the manifold.

Expanded Selection Arm; Primary Study 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 \> 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 \> 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:
• ≥ 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 ≥ 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.
• Patient is ≥ 18 years of age.
• Patient has a life expectancy \> 1 year.

You may not qualify if:

• Patient is a good candidate for and elects open surgical repair.
• Patient can be treated in accordance with the instructions for use with a legally marketed endovascular prosthesis.
• Patient is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site.
• Patient is unwilling to comply with the follow-up schedule.
• Patient is unable or refuses 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 treated portion of the aorta.
• Obstructive stenting of any or all of the visceral vessels.
• Poor performance status including 2 major system failures (cardiovascular, renal, hepatobiliary, neuromuscular).
• Patient has 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.
• Patient has known hypersensitivity or contraindication to anticoagulation or contrast media that cannot be adequately medically managed.
• Patient has an uncorrectable coagulopathy.

Sponsors & Collaborators

• The Christ Hospital: lead
• Medtronic: collaborator

Study Sites (1)

The Christ Hospital

Cincinnati, Ohio, 45219, United States

RECRUITING

Study Officials

• Geoffrey Answini, MD

  The Christ Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Geoffrey Answini, MD

CONTACT

513-585-1777; geoffrey.answini@thechristhospital.com

Darlene Rock

CONTACT

513-585-1777; darlene.rock@thechristhospital.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: March 28, 2017
• First Posted: April 12, 2017
• Study Start: August 1, 2017
• Primary Completion: May 1, 2024
• Study Completion (Estimated): May 1, 2029
• Last Updated: February 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)