NCT01839695

Brief Summary

The Valiant Mona LSA thoracic stent graft system is for the endovascular repair of aneurysms of the descending thoracic aorta (DTA) in patients who require coverage of the left subclavian artery (LSA).The study is intended to assess safety and performance of the device acutely and at 30 days.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2013

Longer than P75 for not_applicable

Geographic Reach
2 countries

3 active sites

Status
completed

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

Study Start

First participant enrolled

April 1, 2013

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

April 11, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 25, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
9 months until next milestone

Results Posted

Study results publicly available

October 29, 2014

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

July 3, 2023

Status Verified

June 1, 2023

Enrollment Period

10 months

First QC Date

April 11, 2013

Results QC Date

October 24, 2014

Last Update Submit

June 28, 2023

Conditions

Thoracic Aortic Aneurysms

Keywords

Thoracic AneurysmEndovascular Aortic RepairTEVAR

Outcome Measures

Primary Outcomes (2)

  • Primary Safety Observation - Rate of Major Adverse Events (MAEs)

    Major Adverse Events is a composite endpoint that includes Aneurysm Related Mortality (ARM), Stroke, Paraplegia, and Left Arm/Hand Ischemia.

    1 month

  • Primary Effectiveness Observation

    Treatment success which is defined as technical success (successful delivery and deployment of the stent graft in the planned location with no unintentional coverage of other vessels, assessed intraoperatively, and the removal of the delivery system) and successful exclusion of the aneurysm while maintaining patency of the MSG and BSG at the 30 day visit.

    1 month

Study Arms (1)

Valiant Mona LSA Stent Graft System

EXPERIMENTAL

TEVAR procedure using Medtronic Stent Graft

Device: Valiant Mona LSA Stent Graft System

Interventions

Valiant Mona LSA Stent Graft SystemDEVICE

All subjects will be implanted with this device

Valiant Mona LSA 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.
  • The subject or legal guardian understands the nature of the study and agrees to its provisions on a written informed consent form
  • Subject must be considered a candidate for revascularization of the LSA.
  • Subject has a DTA which will require coverage of the LSA
  • Subject's anatomy must meet the anatomical criteria to receive that implanted device

You may not qualify if:

  • Subject has had previous endovascular repair of the ascending and/or descending thoracic aorta.
  • Subject is in acute renal failure or has renal insufficiency with a serum creatinine ≥ 2.0 mg/dL
  • Subject is a pregnant female.
  • Enrollment in another clinical study
  • Subject has had a cerebral vascular accident (CVA)or myocardial infarction (MI) within 3 months.
  • Subject has a history of bleeding diathesis, coagulopathy, or refuses blood transfusion.
  • Subject has a known allergy or intolerance to the device components.
  • Subject has a known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Sanger Heart and Vascular Institute

Charlotte, North Carolina, 28203, United States

Location

Cleveland Clinic

Cleveland, Ohio, 27465, United States

Location

St George's Vascular Institute, St. George's Hospital

London, United Kingdom

Location

Related Publications (1)

  • Roselli EE, Arko FR 3rd, Thompson MM; Valiant Mona LSA Trial Investigators. Results of the Valiant Mona LSA early feasibility study for descending thoracic aneurysms. J Vasc Surg. 2015 Dec;62(6):1465-71.e3. doi: 10.1016/j.jvs.2015.07.078. Epub 2015 Oct 23.

    PMID: 26483004DERIVED

MeSH Terms

Conditions

Aortic Aneurysm, Thoracic

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Results Point of Contact

Title
Taryn Dellaripa, Principal Clinical Research Specialist
Organization
Medtronic Vascular
taryn.dellaripa@medtronic.com
541-301-3181

Study Officials

  • Eric Roselli, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2013

First Posted

April 25, 2013

Study Start

April 1, 2013

Primary Completion

February 1, 2014

Study Completion

December 1, 2018

Last Updated

July 3, 2023

Results First Posted

October 29, 2014

Record last verified: 2023-06

Locations

GB(1)US(2)