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

Primary Purpose

Thoracoabdominal Aortic Aneurysm

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Visceral Manifold and Thoracic Bifurcation

Unitary Manifold

TAAA Debranching Stent Graft System

About this trial

This is an interventional treatment trial for Thoracoabdominal Aortic Aneurysm focused on measuring aortic aneurysm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Modified Inclusion Criteria

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

Other inclusion criteria:

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

Exclusion Criteria

General exclusion

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

Medical exclusion criteria

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
Unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina)
Systemic or local infection that may increase the risk of endovascular graft infection
Baseline creatinine greater than 2.0 mg/dL
History of connective tissue disorders (e.g., Marfan Syndrome, Ehler's Danlos Syndrome)

Anatomical exclusion criteria

Thrombus or excessive calcification within the neck of the aneurysm
Branch stenosis ≥ 70%
Anatomy that would not allow maintenance of at least one patent hypogastric artery
Anatomy that would not allow primary or assisted patency of the left subclavian artery

Sites / Locations

Johns Hopkins University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Primary Study Arm

Expanded Selection Arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Treatment Success at 1 Year

Treatment success is defined as a composite of technical success and freedom from the following: Aneurysm enlargement, Aneurysm rupture, Aneurysm-related mortality, Conversion to open repair, Secondary intervention for migration, Type I and III endoleaks, device integrity failure, and patency-related events.

Full Information

NCT ID

NCT03637374

First Posted

August 10, 2018

Last Updated

July 28, 2022

Sponsor

Johns Hopkins University

1. Study Identification

Unique Protocol Identification Number

NCT03637374

Brief Title

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

Official Title

A Study of the Safety, Efficacy, Longitudinal Costs and Patient-Centered Outcomes Using a TAAA Debranching Device

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Terminated

Why Stopped

Investigational device is no longer manufactured

Study Start Date

September 8, 2020 (Actual)

Primary Completion Date

March 21, 2022 (Actual)

Study Completion Date

June 6, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

The primary objective of this clinical investigation is to assess the use of the TAAA Debranching Stent Graft System to repair thoracoabdominal aortic aneurysms. While surgery remains a standard treatment for complex abdominal and thoracoabdominal aneurysms (TAAA), the tolerance of some patients to recover from such extensive and invasive open aortic reconstructions is poor. Endovascular repair may offer the opportunity to reduce patient risk with less invasive approaches, improve quality of life, and serve to reduce the cost burden. The primary technical safety endpoint is freedom from major adverse events (MAE) at 30 days or during hospitalization if this exceeds 30 days. The primary effectiveness endpoint is the proportion of study subjects with treatment success at 1 year.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Thoracoabdominal Aortic Aneurysm

Keywords

aortic aneurysm

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Primary Study Arm

Arm Type

Experimental

Arm Description

Arm Title

Expanded Selection Arm

Arm Type

Other

Arm Description

Intervention Type

Device

Intervention Name(s)

Visceral Manifold and Thoracic Bifurcation

Intervention Description

Endovascular stent graft system

Intervention Type

Device

Intervention Name(s)

Unitary Manifold

Intervention Description

Endovascular stent graft system

Intervention Type

Device

Intervention Name(s)

TAAA Debranching Stent Graft System

Intervention Description

Endovascular stent graft system

Primary Outcome Measure Information:

Title

Freedom From Major Adverse Events (MAEs) at 30 Days

Description

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

Time Frame

30 days

Secondary Outcome Measure Information:

Title

Treatment Success at 1 Year

Description

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Modified Inclusion Criteria 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 Other inclusion criteria: 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 Exclusion Criteria General exclusion 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 Medical exclusion criteria 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 Unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina) Systemic or local infection that may increase the risk of endovascular graft infection Baseline creatinine greater than 2.0 mg/dL History of connective tissue disorders (e.g., Marfan Syndrome, Ehler's Danlos Syndrome) Anatomical exclusion criteria Thrombus or excessive calcification within the neck of the aneurysm Branch stenosis ≥ 70% Anatomy that would not allow maintenance of at least one patent hypogastric artery Anatomy that would not allow primary or assisted patency of the left subclavian artery

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James H Black, MD

Organizational Affiliation

Johns Hopkins University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Johns Hopkins University

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

24997805

Citation

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.

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

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