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Endovascular Prosthesis

Endovascular Repair for Aortic Disease

N/A
Recruiting
Led By Rodney A White, MD
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
Patients must have a Type IV complex thoracoabdominal aortic lesion and be considered candidates for endovascular repair
Patients must have a nonaneurysmal proximal aortic segment distal to the left subclavian artery with at least 2 cm length to assure secure proximal fixation with a minimum diameter of 28 mm, maximum diameter of 42mm, angle less than 60° relative to axis of the aneurysm, and angle less than 60° relative to axis of the thoracic aorta
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up tp 5 years post intervention
Awards & highlights

Study Summary

This trial is testing whether a physician-modified Medtronic Thoracic Valiant stent graft is effective in treating complex thoracoabdominal aortic lesions.

Who is the study for?
This trial is for adults over 21 with complex Type IV thoracoabdominal aortic lesions who are high-risk surgical candidates. They must have specific anatomical features that fit the criteria for endovascular repair, such as compatible ileofemoral access and left subclavian artery anatomy. Pregnant individuals, those likely to infect the stent graft, or with allergies to its materials cannot participate.Check my eligibility
What is being tested?
The study tests a modified Medtronic Valiant Thoracic Stent Graft on patients with aortic disease. The device is customized by doctors to match patient anatomy and delivered through arteries to exclude the lesion and restore blood flow.See study design
What are the potential side effects?
Potential side effects may include complications related to device implantation like bleeding, infection at the entry site, damage to blood vessels, reaction to materials in the stent graft, and possible impact on organ function due to changes in blood flow.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a complex aortic lesion and am eligible for a non-surgical repair procedure.
Select...
My aorta near my heart fits the required size and shape for a safe procedure.
Select...
My iliac artery is wider than 12mm and longer than 2cm.
Select...
My left subclavian artery can safely accommodate an 8 mm conduit.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years post intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years post intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Additional endovascular procedure
All cause mortality
Conversion to open repair
+1 more
Secondary outcome measures
Composite of myocardial infarction, organ failure, sepsis
Technical observations
Vessel complications

Trial Design

1Treatment groups
Experimental Treatment
Group I: Endovascular Device ImplantationExperimental Treatment2 Interventions
Endoluminal exclusion of thoracoabdominal lesion

Find a Location

Who is running the clinical trial?

Rodney A. White, M.D.Lead Sponsor
3 Previous Clinical Trials
373 Total Patients Enrolled
Long Beach Memorial Medical CenterOTHER
6 Previous Clinical Trials
4,050 Total Patients Enrolled
Rodney A White, MDPrincipal InvestigatorLos Angeles BioMedical Research Institute, Vascular Surgery and Medical Director, Vascular Surgery Long Beach Memorial Heart & Vascular Institute, Long Beach, CA

Media Library

Physician Modified Endovascular Prosthesis (Endovascular Prosthesis) Clinical Trial Eligibility Overview. Trial Name: NCT02524834 — N/A
Aortic Disease Research Study Groups: Endovascular Device Implantation
Aortic Disease Clinical Trial 2023: Physician Modified Endovascular Prosthesis Highlights & Side Effects. Trial Name: NCT02524834 — N/A
Physician Modified Endovascular Prosthesis (Endovascular Prosthesis) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02524834 — N/A

Frequently Asked Questions

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

Are there still openings for participation in this medical trial?

"As per clinicaltrials.gov, the current recruitment period for this medical study commenced on July 1st 2015 and was last updated in March 11th 2022."

Answered by AI

Is it feasible for me to take part in this scientific investigation?

"This medical trial is looking for 15 individuals between the age of 21 and 90 with aortic diseases. Additionally, these participants must meet the following criteria: An angle less than 60° relative to axis of the thoracic aorta; Type IV complex thoracoabdominal aortic lesion amenable to endovascular repair; ileofemoral access compatible with delivery of 25 Fr MedtronicValiant thoracic endograft ; left subclavian artery anatomy that allows 8 mm Dacron conduit antegrade deployments; nonaneurysmal proximal aortic segment distal to left"

Answered by AI

How many individuals are enrolled in the current trial?

"Affirmative, the information provided on clinicaltrials.gov indicates that this research endeavour is actively looking for participants. The study has been visible since July 1st 2015 and was most recently edited March 11th 2022; 15 patients are required between two different locations."

Answered by AI

Is this research protocol accessible to persons younger than 65 years of age?

"The age range of participants accepted into this study extends from their 21st birthday up to 90 years old."

Answered by AI
~6 spots leftby Jul 2030