Safety, Efficacy, Longitudinal Costs and Patient-Centered Outcomes Using a TAAA Debranching Device

NCT03637374 | Terminated Results DMC FDA Device

• 1 other identifier: IRB00075706
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this study is to assess the use of the TAAA Debranching Stent Graft System to repair thoracoabdominal aortic aneurysms in patients having appropriate anatomy, as measured by device safety, effectiveness, costs of delivery of aortic surgery care, and patient quality of life domains. Additionally, the study will assess technical success and treatment success at each follow-up interval.

Conditions

Thoracoabdominal Aortic Aneurysm

Keywords

aortic aneurysm

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 (1)

• Treatment Success at 1 Year

  1 year

Study Arms (2)

Primary Study Arm

EXPERIMENTAL

The TAAA Debranching Stent Graft System is comprised of two investigational devices including the Visceral Manifold and Thoracic Bifurcation 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; Device: TAAA Debranching Stent Graft System

Expanded Selection Arm

OTHER

The Expanded Selection Arm will be treated the same as those in the Primary Study Arm. Your doctor will determine what arm you are in. TAAA Debranching Stent Graft System is comprised of two investigational devices including the Visceral Manifold and Thoracic Bifurcation 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; Device: TAAA Debranching Stent Graft System

Interventions

Visceral Manifold and Thoracic Bifurcation DEVICE

Endovascular stent graft system

Expanded Selection Arm; Primary Study Arm

Unitary Manifold DEVICE

Endovascular stent graft system

Expanded Selection Arm; Primary Study Arm

TAAA Debranching Stent Graft System DEVICE

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:

• 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 healthy/nondiseased tissue (including previously placed graft material) (neck) distal to the left subclavian artery (LSA) diameter in the range of 26-42 mm
• ≥2.5cm of surgical graft distal to the left subclavian artery (LSA) diameter in the range of 26-42mm.
• 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 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
• Patency of the four major visceral vessels (SMA, celiac, right renal, left renal)
• Age: ≥ 18 years old
• Life expectancy: \> 1 year

You may not qualify if:

• Patient is a good candidate for and elects open surgical repair
• Can be treated in accordance with the instructions for use with a legally marketed endovascular prosthesis
• Is eligible for enrollment in a manufacturer-sponsored investigational device exemption (IDE) at the investigational site
• Unwilling to comply with the follow-up schedule
• Inability or refusal to give informed consent by patient or legal representative
• 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
• 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
• Body habitus that would inhibit x-ray visualization of the aorta or exceeds the safe capacity of the equipment
• Patient has had a major surgical or interventional procedure unrelated to the treatment of the aneurysm planned \< 30 days of the endovascular repair

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

• 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

MeSH Terms

Conditions

Aortic Aneurysm, Thoracoabdominal; Aortic Aneurysm

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Enrollment is permanently closed because the investigational device is no longer manufactured. The target enrollment was not reached and there was insufficient power to measure the effect of the intervention.

Results Point of Contact

• Title: Dr. James H. Black, III
• Organization: Johns Hopkins University

jhblack@jhmi.edu

(410) 955-5165

Study Officials

• James H Black, MD

  Johns Hopkins University

  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: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2018
• First Posted: August 20, 2018
• Study Start: September 8, 2020
• Primary Completion: March 21, 2022
• Study Completion: June 6, 2022
• Last Updated: August 19, 2022
• Results First Posted: August 19, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)