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Evaluation of the Valiant Mona LSA Thoracic Stent Graft System in Thoracic Aortic Aneurysms and Chronic Dissections (MONA-LSA)

Primary Purpose

Aortic Aneurysm, Thoracic

Status

Withdrawn

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Valiant Mona LSA Thoracic Stent Graft System

About this trial

This is an interventional device feasibility trial for Aortic Aneurysm, Thoracic focused on measuring stent graft, branch stent graft, thoracic aneurysm, endovascular aortic repair, aortic dissection, Valiant Mona LSA Thoracic Stent Graft System

Eligibility Criteria

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

Inclusion Criteria:

Subject is at least 18 years of age.
Subject understands and has signed an Informed Consent
Subject must be considered a candidate for revascularization of the LSA.
Subject must be able to tolerate a surgical revascularization of the LSA.
Subject has a descending thoracic aneurysm (DTA) which will require coverage of the LSA
Subject has a healthy, non-diseased aortic proximal seal zone of at least 10 mm from the left carotid to the LSA and at least 5 mm landing zone distal to the LSA and proximal to the start of the aneurysm/ulcer/or the proximal entry tear for dissection.
Subject has a non-diseased aortic diameter between 25 mm and 42 mm (fusiform/saccular aneurysms or penetrating ulcers) or 28 mm to 44 mm (chronic type B dissections),
Subject has a LSA with a diameter between 8 mm and 13 mm.
Subject has sufficient landing zone within the LSA to accommodate the BSG without occlusion of any significant vessels
Subject has patent brachial arteries, iliac or femoral arteries (without circumferential calcifications and a diameter of ≥ 10mm), or can tolerate a conduit that will allow endovascular access to the aneurysmal site with the delivery system of the appropriate sized device chosen for treatment.
Subject has a condition requiring prospective revascularization of the LSA

Exclusion Criteria:

Subject has an aneurysmal, tortuous, or atherosclerotic LSA, conflicting the branch graft insertion.
Subject has an aortic atheroma classified as grade IV or grade V.
Subject has prohibitive calcification, occlusive disease, or tortuosity of intended fixation sites.
Treatment with the Valiant Mona LSA Thoracic Stent Graft system would require intentional coverage of the left common carotid artery with the stent graft fabric.
Subject has significant and/or circumferential aortic mural thrombus at either the proximal or distal attachment sites that would compromise fixation and seal of the device.
Subject is a pregnant or breastfeeding female.
Subject has a known allergy or intolerance to the device components.
Subject is in acute renal failure or has renal insufficiency with a serum creatinine ≥ 2.0 mg/dL or is on dialysis.
Subject has coronary artery disease with unstable angina and has not received treatment.
Subject has a connective tissue disease (e.g. Marfan's syndrome, medial degeneration).
Subject has active systemic infection and/or a mycotic aneurysm.
Subject is currently participating in an investigational drug or device clinical trial that would interfere with the observations of this study.
Subject has other medical, social, or psychological problems that, in the opinion of the investigator, will interfere with treatment and follow-up procedures.
Subject has a life expectancy of less than 1 year.
Subject has a history of bleeding diathesis, coagulopathy, or refuses blood transfusion.
Subject has a known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment.

Sites / Locations

Hôpital Timone Adultes
CHU Toulouse, Hôpital Rangueil

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Valiant Mona LSA Thoracic Stent Graft System

Arm Description

The Valiant Mona LSA Thoracic Stent Graft System is administered.

Outcomes

Primary Outcome Measures

Safety events (aorta related mortality, stroke, paraplegia, left arm/hand ischemia)

Composite endpoint defined as the occurrence of one of the following events: aorta related mortality, stroke, paraplegia, left arm/hand ischemia

Effectiveness

Effectiveness defined as technical success and successful exclusion of the aneurysm or false lumen while maintaining patency of the main stent graft (MSG) and branch stent graft (BSG)

Secondary Outcome Measures

Aorta related mortality

Occurrence of aorta related mortality

Stroke

Occurrence of stroke

Paraplegia

Occurrence of paraplegia

Left arm/hand ischemia

Occurrence of left arm/hand ischemia

Effectiveness (Successful exclusion of the aneurysm)

Successful exclusion of the aneurysm

Effectiveness (patency)

False lumen while maintaining patency of the main stent graft (MSG) and branch stent graft (BSG)

Duration of the intervention

Necessary time for the branch placement

Characteristics of the intervention (general anaesthesia)

General anaesthesia performing

Characteristics of the intervention (blood loss)

Blood loss volume

Characteristics of the intervention (transfusion)

Transfusion performing

Duration of the stay in intensive care

Duration of the hospitalization

Characteristics of the hospitalization (intraoperative complications)

Occurrence of intraoperative complications

Quality of life with EuroQol-5D

The quality of life will be measured with the EuroQol-5D (5 levels) questionnaire

Minor adverse events

Occurrence of minor adverse events

Serious adverse events

Occurrence of serious adverse events

Full Information

NCT ID

NCT03738124

First Posted

November 8, 2018

Last Updated

August 24, 2020

Sponsor

University Hospital, Toulouse

Collaborators

Medtronic Vascular

1. Study Identification

Unique Protocol Identification Number

NCT03738124

Brief Title

Evaluation of the Valiant Mona LSA Thoracic Stent Graft System in Thoracic Aortic Aneurysms and Chronic Dissections

Acronym

MONA-LSA

Official Title

Evaluation of the Valiant Mona LSA Thoracic Stent Graft System in Thoracic Aortic Aneurysms and Chronic Dissections

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Withdrawn

Why Stopped

Production of the medical device was stopped

Study Start Date

January 2019 (Anticipated)

Primary Completion Date

March 2021 (Anticipated)

Study Completion Date

February 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Toulouse

Collaborators

Medtronic Vascular

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

To ensure adequate seal of currently available stent grafts, a proximal 20 mm of healthy aorta is recommended. Extending the proximal landing zone into the arch by intentional covering of the left subclavian artery (LSA) without revascularization expose to serious neurologic complications. Serious risks are also known to accompany subclavian revascularization. The Valiant Mona LSA Thoracic Stent Graft System (Medtronic,Santa Rosa, Calif) consists of a main stent graft and a branch stent graft designed to maintain LSA patency. The purpose of this study is to characterize the safety and effectiveness of this device for the treatment of Aneurysms and chronic Type B dissections of the arch.

Detailed Description

Stent graft coverage of the left subclavian artery (LSA) may be required to achieve an adequate landing zone in up to 40% of descending thoracic aneurysms (DTAs). To ensure adequate seal of currently available off-the-shelf stent grafts, 20 mm of healthy aorta is recommended between the proximal neck of the aneurysm and the leading edge of the stent graft. Stent graft placement can be facilitated by extending the proximal landing zone into the arch and covering the LSA; however, there may be a higher risk of serious neurologic outcomes (cerebral and paraplegia), although this is still a matter of debate. Serious risks are also known to accompany subclavian revascularization, which may involve bypass or transposition. The Valiant Mona LSA Thoracic Stent Graft System (Medtronic,Santa Rosa, Calif) consists of a main stent graft and a branch stent graft designed to maintain LSA patency while diverting circulation through the encroaching aneurysm. The purpose of the feasibility study is to characterize the safety of the Valiant Mona LSA Thoracic Stent Graft System, including an assessment of the safety and effectiveness of the device acutely and at the 1-month visit in the identified subject population (Aneurysms and chronic, Type B dissections). A follow up of this population will be annually during 5 years. This pilot, non-randomized, single-arm prospective study will concern 20 patients. Inclusion criteria required patients with a thoracic aortic aneurysm (TAA) or dissection with an indication of a stent-Graft insertion. Primary end points will be aneurysm-related mortality, stroke, paraplegia, left arm/hand ischemia, and treatment success. Technical success will be assessed by imaging at 1 month, 6 months then annually during 5 years.

6. Conditions and Keywords

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

Aortic Aneurysm, Thoracic

Keywords

stent graft, branch stent graft, thoracic aneurysm, endovascular aortic repair, aortic dissection, Valiant Mona LSA Thoracic Stent Graft System

7. Study Design

Primary Purpose

Device Feasibility

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Valiant Mona LSA Thoracic Stent Graft System

Arm Type

Experimental

Arm Description

The Valiant Mona LSA Thoracic Stent Graft System is administered.

Intervention Type

Device

Intervention Name(s)

Valiant Mona LSA Thoracic Stent Graft System

Intervention Description

The Valiant Mona LSA device is a modular two-component system consisting of a main stent graft (MSG) and a branch stent graft (BSG), delivered separately, designed to maintain LSA perfusion. Briefly, under general anesthesia and after heparin injection, a MSG access is achieved via a femoral artery. A Through-and-through wire access for delivery of the BSG is achieved via a brachial artery. After the placement of the main aortic stent graft in the arch with the cuff at the level of the ostium of the LSA, the BSG is placed through a femoral access.

Primary Outcome Measure Information:

Title

Safety events (aorta related mortality, stroke, paraplegia, left arm/hand ischemia)

Description

Composite endpoint defined as the occurrence of one of the following events: aorta related mortality, stroke, paraplegia, left arm/hand ischemia

Time Frame

1 month

Title

Effectiveness

Description

Effectiveness defined as technical success and successful exclusion of the aneurysm or false lumen while maintaining patency of the main stent graft (MSG) and branch stent graft (BSG)

Time Frame

1 month

Secondary Outcome Measure Information:

Title

Aorta related mortality

Description

Occurrence of aorta related mortality

Time Frame