NCT03738124

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 13, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

August 26, 2020

Status Verified

August 1, 2020

Enrollment Period

2.2 years

First QC Date

November 8, 2018

Last Update Submit

August 24, 2020

Conditions

Aortic Aneurysm, Thoracic

Keywords

stent graftbranch stent graftthoracic aneurysmendovascular aortic repairaortic dissectionValiant Mona LSA Thoracic Stent Graft System

Outcome Measures

Primary Outcomes (2)

  • 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

    1 month

  • 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)

    1 month

Secondary Outcomes (17)

  • Aorta related mortality

    6 months, 12 months, 24 months, 36 months, 48 months and 60 months

  • Stroke

    6 months, 12 months, 24 months, 36 months, 48 months and 60 months

  • Paraplegia

    6 months, 12 months, 24 months, 36 months, 48 months and 60 months

  • Left arm/hand ischemia

    6 months, 12 months, 24 months, 36 months, 48 months and 60 months

  • Effectiveness (Successful exclusion of the aneurysm)

    6 months, 12 months, 24 months, 36 months, 48 months and 60 months

  • +12 more secondary outcomes

Study Arms (1)

Valiant Mona LSA Thoracic Stent Graft System

EXPERIMENTAL

The Valiant Mona LSA Thoracic Stent Graft System is administered.

Device: Valiant Mona LSA Thoracic Stent Graft System

Interventions

Valiant Mona LSA Thoracic Stent Graft SystemDEVICE

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.

Valiant Mona LSA Thoracic Stent Graft System

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hôpital Timone Adultes

Marseille, 13385, France

Location

CHU Toulouse, Hôpital Rangueil

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Aortic Aneurysm, ThoracicAortic Dissection

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic DiseasesDissection, Blood VesselAcute Aortic Syndrome

Study Officials

  • Hervé ROUSSEAU, MD

    University Hospital of Toulouse

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2018

First Posted

November 13, 2018

Study Start

January 1, 2019

Primary Completion

March 1, 2021

Study Completion

February 1, 2026

Last Updated

August 26, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)