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Stent Graft

Endovascular Stent Graft for Aortic Dissection

N/A

Recruiting

Led By Rodney A White, M.D.

Research Sponsored by Rodney A. White, M.D.

Eligibility Criteria Checklist

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

Must have

Patient must also have at least one cm proximal and distal landing zones in the ascending aorta between 28-44 mm in diameter

Patient must have a Type A thoracic aortic dissection, retrograde Type A thoracic aortic dissection, intramural hematoma, penetrating ulcer or pseudoaneurysm of the ascending thoracic aorta affecting the area between the Sinus of Valsalva and the innominate artery orifice (with no involvement of the aortic valve) and be considered candidates for endovascular repair

Timeline

Screening 3 weeks

Treatment Varies

Follow Up to 30 days

Awards & highlights

Study Summary

This trial is to study the use of a Medtronic stent graft to treat patients with diseases of the ascending thoracic aorta. This stent graft is designed to reroute blood flow around a tear in the aorta, and has been used extensively in patients with type B aortic dissection. The goal of this study is to see if the stent graft performs similarly in patients with type A aortic dissection.

Who is the study for?

This trial is for adults with specific aortic conditions like Type A thoracic aortic dissection and similar issues, who are high-risk surgical candidates but can undergo endovascular repair. It excludes pregnant individuals, those under 21, patients not expected to live more than a year, or with allergies to stent materials.Check my eligibility

What is being tested?

The study tests the Medtronic Valiant PS-IDE Stent Graft's effectiveness in repairing ascending thoracic aorta pathologies. The device has been used for type B dissections and may work similarly for type A by rerouting blood flow.See study design

What are the potential side effects?

Potential side effects might include complications related to the stent graft placement such as infection, allergic reactions to materials, or issues arising from improper blood flow redirection.

Eligibility Criteria

Inclusion Criteria

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

Select...

My aorta is the right size for the procedure.

Select...

I have a specific type of aortic dissection or related condition and am a candidate for a less invasive repair.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ to 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~to 30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and to 30 days for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Composite of all cause mortality, re-interventions, surgical conversions, post-procedural strokes and ischemic or hemorrhagic events causing motoric, language or cognitive compromise

Secondary outcome measures

A composite of successful delivery and deployment of stent graft, coverage of lesion and/or proximal entry tear, aortic remodeling based on serial imaging, rupture

Trial Design

1Treatment groups

Experimental Treatment

Group I: Endovascular repair of ascending aortaExperimental Treatment1 Intervention

Endovascular repair with Valiant PS-IDE Stent Graft

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rodney A. White, M.D.Lead Sponsor

3 Previous Clinical Trials

368 Total Patients Enrolled

1 Trials studying Aortic Dissection

304 Patients Enrolled for Aortic Dissection

Rodney A White, M.D.Principal InvestigatorLA BioMedical Research Institute at Harbor-UCLA Medical Center

Ali Khoynezhad, M.D. PhD.Principal InvestigatorLA BioMedical Research Institute at Harbor-UCLA Medical Center

Frequently Asked Questions

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

Are there opportunities for new enrollees in this research endeavor?

"As reported on clinicaltrials.gov, this trial is actively seeking participants and was initially posted on September 1st 2013 with its most recent update occurring on August 2nd 2022."

Answered by AI

How expansive is the recruitment process for this research endeavor?

"Affirmative. Clinicaltrials.gov contains information demonstrating that this research is currently recruiting participants; the study was initially posted on September 1st 2013 and its most recent update occurred August 2nd 2022. This investigation requires 20 patients to be sourced from two distinct locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Feasibility of Endovascular Repair Of Ascending Aortic Pathologies

Rodney A. White, M.D. 2013. "Feasibility of Endovascular Repair Of Ascending Aortic Pathologies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02201589.