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Stent Graft System

Valiant Mona LSA Stent Graft for Aortic Aneurysm

N/A

Waitlist Available

Research Sponsored by Medtronic Cardiovascular

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject has a healthy, non-diseased aortic proximal seal zone of at least 20 mm from the distal end of the LCC ostium to the beginning of the disease, including at least 10 mm between the LSA and the LCC.

Subject has a non-diseased aortic diameter between 25 mm and 42 mm

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month

Awards & highlights

Study Summary

This trialwill assess the safety and effectiveness of the device and evaluate the instructions for use.

Who is the study for?

This trial is for adults over 18 with thoracic aortic aneurysms or dissections who can undergo revascularization. Candidates must have specific measurements of their aneurysm and healthy vessel areas where the stent graft can be placed, without significant risk factors that would complicate surgery.Check my eligibility

What is being tested?

The Valiant Mona LSA Thoracic Stent Graft System is being tested to see if it's safe and effective when used in patients with descending thoracic aortic aneurysms and chronic dissections. The study looks at immediate results and checks how patients are doing after 30 days.See study design

What are the potential side effects?

While not explicitly listed, side effects may include typical risks associated with endovascular procedures such as bleeding, infection, blood vessel damage, or issues related to the stent graft like movement or leakage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My aorta near my heart is healthy and has enough space for a seal.

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My aorta's size is within the normal range.

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I am 18 years old or older.

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I am a candidate for and can undergo surgery to improve blood flow in my LSA.

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My healthy artery is between 8 mm and 13 mm wide.

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My aorta near my left subclavian artery is healthy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

30 Day Composite Safety Endpoint

30 Day Treatment Success

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment with Valiant Mona LSA deviceExperimental Treatment1 Intervention

Treatment with Valiant Mona LSA device

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Medtronic CardiovascularLead Sponsor

75 Previous Clinical Trials

36,300 Total Patients Enrolled

Media Library

Valiant Mona LSA Thoracic Stent Graft System (Stent Graft System) Clinical Trial Eligibility Overview. Trial Name: NCT02365467 — N/A

Thoracic Aortic Aneurysm and Dissection Research Study Groups: Treatment with Valiant Mona LSA device

Thoracic Aortic Aneurysm and Dissection Clinical Trial 2023: Valiant Mona LSA Thoracic Stent Graft System Highlights & Side Effects. Trial Name: NCT02365467 — N/A

Valiant Mona LSA Thoracic Stent Graft System (Stent Graft System) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02365467 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this study still accepting participants?

"The clinicaltrials.gov platform demonstrates that this medical trial, which was posted on the first day of April 2015 and amended on September 27th 2022, is not presently enrolling patients. However, there are 152 other studies currently seeking participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2015. "Evaluation of the Valiant Mona LSA Thoracic Stent Graft System in Descending TAA and Chronic Dissections". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02365467.