Visceral Manifold and Unitary Device Study for the Repair of Thoracoabdominal Aortic Aneurysms

NCT02294435 | Active Not Recruiting DMC FDA Device

• 1 other identifier: SH VMS
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the Visceral Manifold and Unitary Device Study is to assess the use of the thoracic bifurcation and the visceral manifold or the unitary device 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 Aneurysms

Keywords

Thoracoabdominal Aneurysms; Endovascular; Ps-ide; Early Feasibility; Aneurysm; Aortic Aneurysm, Thoracic; Aortic Aneurysm; Aortic Diseases; Cardiovascular Diseases; Vascular Diseases; Pararenal aneurysm; Juxtarenal aneurysm; Aortic dissection; Short neck infrarenal aneurysm; Type 4 thoracoabdominal; TAAA

Outcome Measures

Primary Outcomes (1)

• Freedom from major adverse events (MAEs) at 30 days

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

  30 days

Secondary Outcomes (2)

• Treatment success and technical success at 1 year

  1 year

• Treatment success at various timepoints

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

Study Arms (2)

Primary Study Arm

EXPERIMENTAL

The TAAA Debranching Stent Graft System is comprised of two investigational devices including the Thoracic Bifurcation and the Visceral Manifold and the Unitary Manifold. The thoracic bifurcation and the visceral manifold as well as the unitary manifold work to facilitate endovascular stenting of the visceral vessels (renals, celiac, SMA) while maintaining flow to the visceral and infrarenal segments.

Device: Visceral Manifold and Thoracic Bifurcation; Device: Unitary Manifold

Expanded Selection Arm

EXPERIMENTAL

The expanded selection arm is for subjects not eligible for open repair or other endovascular options due to comorbidities or anatomical limitations and do not meet inclusion in the primary study arm. The Thoracic Bifurcation and the Visceral Manifold as well as the Unitary Manifold work to facilitate endovascular stenting of the visceral vessels (renals, celiac, SMA) while maintaining flow to the visceral and infrarenal segments.

Device: Visceral Manifold and Thoracic Bifurcation; Device: Unitary Manifold

Interventions

Visceral Manifold and Thoracic Bifurcation DEVICE

Visceral Manifold and Thoracic Bifurcation Endovascular stent graft system

Expanded Selection Arm; Primary Study Arm

Unitary Manifold DEVICE

Unitary Manifold Endovascular stent graft system

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:

• 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 or equal to 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:
• ≥ 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
• Proximal landing zone for the unitary manifold stent graft:
• Nonaneurysmal aortic segment including previously placed graft material (neck) with a minimum seal zone length of 3 cm
• Diameter in the range of 19-32 mm
• Iliac artery or aortic distal fixation site greater than or equal to 15 mm in length and diameter in the range of 8 - 25 mm
• Age: ≥ 18 years old
• Life expectancy: \> 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
• 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 (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)
• Known hypersensitivity or contraindication to anticoagulation or contrast media that cannot be adequately medically managed
• Uncorrectable coagulopathy

Sponsors & Collaborators

• Sanford Health: lead
• Dakota Vascular: collaborator

Study Sites (1)

Unknown Facility

Sioux Falls, South Dakota, 57117, United States

Location

Related Publications (2)

• Anderson J, Nykamp M, Danielson L, Remund T, Kelly PW. A novel endovascular debranching technique using physician-assembled endografts for repair of thoracoabdominal aneurysms. J Vasc Surg. 2014 Nov;60(5):1177-1184. doi: 10.1016/j.jvs.2014.05.090. Epub 2014 Jul 3.

  PMID: 24997805 BACKGROUND

• Jorgensen BD, Malek M, VandenHull A, Remund T, Truong KC, Pohlson K, Kelly PW. A novel physician-assembled endograft for the repair of pararenal, paravisceral, Crawford type IV thoracoabdominal aortic aneurysms, and aneurysms requiring treatment after prior repair. J Vasc Surg. 2020 Dec;72(6):1897-1905.e2. doi: 10.1016/j.jvs.2020.03.045. Epub 2020 Apr 23.

  PMID: 32335306 DERIVED

MeSH Terms

Conditions

Aneurysm; Aortic Aneurysm, Thoracic; Aortic Aneurysm; Aortic Diseases; Cardiovascular Diseases; Vascular Diseases; Aortic Dissection

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Acute Aortic Syndrome

Study Officials

• Patrick Kelly, MD

  PRINCIPAL INVESTIGATOR

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: Vascular Surgeon

Study Record Dates

• First Submitted: November 14, 2014
• First Posted: November 19, 2014
• Study Start: February 1, 2015
• Primary Completion: January 31, 2024
• Study Completion (Estimated): December 1, 2029
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)