RECRUITING

Repair of Thoracoabdominal Aortic Aneurysms

Conditions

Thoracoabdominal Aneurysm endograft repair,

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Study Overview

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Description

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.

Official Title

Endograft Repair of Thoracoabdominal Aortic Aneurysms (TAAA)

Quick Facts

Study Start:2017-08-01

Study Completion:2029-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03111459

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. A patient may be entered into the study if the patient has at least one of the following: 1. 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 2. aneurysm with a history of growth \> 0.5 cm in 6 months 3. saccular aneurysm deemed at significant risk for rupture 4. symptomatic aneurysm greater than 4.5 cm 2. 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. 3. Proximal landing zone for the thoracic bifurcation stent graft that has: 1. ≥ 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. 2. 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. 4. Minimum branch vessel diameter ≥ 5 mm. 5. 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. 6. Patient is ≥ 18 years of age. 7. Patient has a life expectancy \> 1 year.	1. Patient is a good candidate for and elects open surgical repair. 2. Patient can be treated in accordance with the instructions for use with a legally marketed endovascular prosthesis. 3. Patient is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site. 4. Patient is unwilling to comply with the follow-up schedule. 5. Patient is unable or refuses to give informed consent. 6. Urgent or emergent presentation. 7. Patient is pregnant or breastfeeding. 8. Patient has a contained rupture. 9. Patient has a ruptured aneurysm. 10. Patient has a dissection in the treated portion of the aorta. 11. Obstructive stenting of any or all of the visceral vessels. 12. Poor performance status including 2 major system failures (cardiovascular, renal, hepatobiliary, neuromuscular).

Inclusion Criteria

Exclusion Criteria

1. A patient may be entered into the study if the patient has at least one of the following:
1. 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
2. aneurysm with a history of growth \> 0.5 cm in 6 months
3. saccular aneurysm deemed at significant risk for rupture
4. symptomatic aneurysm greater than 4.5 cm
2. 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.
3. Proximal landing zone for the thoracic bifurcation stent graft that has:
1. ≥ 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.
2. 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.
4. Minimum branch vessel diameter ≥ 5 mm.
5. 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.
6. Patient is ≥ 18 years of age.
7. Patient has a life expectancy \> 1 year.

1. Patient is a good candidate for and elects open surgical repair.
2. Patient can be treated in accordance with the instructions for use with a legally marketed endovascular prosthesis.
3. Patient is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site.
4. Patient is unwilling to comply with the follow-up schedule.
5. Patient is unable or refuses to give informed consent.
6. Urgent or emergent presentation.
7. Patient is pregnant or breastfeeding.
8. Patient has a contained rupture.
9. Patient has a ruptured aneurysm.
10. Patient has a dissection in the treated portion of the aorta.
11. Obstructive stenting of any or all of the visceral vessels.
12. Poor performance status including 2 major system failures (cardiovascular, renal, hepatobiliary, neuromuscular).

Contacts and Locations

Study Contact

Geoffrey Answini, MD

CONTACT

513-585-1777

geoffrey.answini@thechristhospital.com

Darlene Rock

CONTACT

513-585-1777

darlene.rock@thechristhospital.com

Principal Investigator

Geoffrey Answini, MD

PRINCIPAL_INVESTIGATOR

The Christ Hospital

Study Locations (Sites)

The Christ Hospital

Cincinnati, Ohio, 45219

United States

Collaborators and Investigators

Sponsor: The Christ Hospital

Geoffrey Answini, MD, PRINCIPAL_INVESTIGATOR, The Christ Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-08-01

Study Completion Date2029-05

Study Record Updates

Study Start Date2017-08-01

Study Completion Date2029-05

Terms related to this study

Keywords Provided by Researchers

endograft repair,

Additional Relevant MeSH Terms

Thoracoabdominal Aneurysm