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

Not Applicable

Terminated

Conditions: Thoracoabdominal Aortic Aneurysm

Interventions: Device: Visceral Manifold and Thoracic Bifurcation
Device: Unitary Manifold
Device: TAAA Debranching Stent Graft System

Registration Number: NCT03637374

Lead Sponsor: Johns Hopkins University

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 2

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

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Primary Study Arm	Visceral Manifold and Thoracic Bifurcation	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.
Primary Study Arm	TAAA Debranching Stent Graft System	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.
Primary Study Arm	Unitary Manifold	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.
Expanded Selection Arm	Visceral Manifold and Thoracic Bifurcation	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.
Expanded Selection Arm	TAAA Debranching Stent Graft System	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.
Expanded Selection Arm	Unitary Manifold	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.

Primary Outcome Measures

Name	Time	Method
Freedom From Major Adverse Events (MAEs) at 30 Days	30 days	Major adverse events include death, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, and stroke.

Secondary Outcome Measures

Name	Time	Method
Treatment Success at 1 Year	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.