Safety and Efficacy of Valiant Mona LSA Stent Graft System

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2018-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of the Valiant Mona LSA Thoracic Stent Graft System in Descending TAA and Chronic Dissections

NCT02365467

Aortic Aneurysm, Thoracic, Chronic Type B Dissection

COMPLETED

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

NCT03738124

Aortic Aneurysm, Thoracic

WITHDRAWN NA

Clinical Study of Thoracic Aortic Aneurysm Exclusion

NCT00549315

Thoracic Aortic Aneurysm

UNKNOWN NA

Valor II: The Valiant Thoracic Stent Graft System Clinical Study

NCT00413231

Thoracic Aortic Aneurysm

COMPLETED NA

Post-Approval Clinical Study of the Talent Thoracic Stent Graft to Treat Thoracic Aortic Aneurysms (THRIVE)

NCT00805948

Thoracic Aortic Aneurysms

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Thoracic Aortic Aneurysms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Valiant Mona LSA Stent Graft System

TEVAR procedure using Medtronic Stent Graft

Group Type EXPERIMENTAL

Valiant Mona LSA Stent Graft System

Intervention Type DEVICE

All subjects will be implanted with this device

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Valiant Mona LSA Stent Graft System

All subjects will be implanted with this device

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No