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Catheterized Stenting for Heart Problems
Study Summary
This trial is testing a new stent for infants and young children with heart problems. They want to see if it's safe and effective.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- You weigh less than 1.5 kilograms.I need stents in more than one of my blood vessels.The doctor thinks it's not safe to put a stent in the location of the lesion.I have been on antibiotics for a bloodstream infection within the last 3 days.I have not been treated for endocarditis within the last 6 months.You are allergic to cobalt-chromium or contrast dye and cannot take medicine to prevent an allergic reaction.I have at least one open and usable vein or artery in my leg, neck, or near my heart for treatment delivery.I need treatment for a narrowing in my heart's aorta or pulmonary artery.I have an aneurysm in my aorta or pulmonary artery where treatment is planned.My non-heart related illness may shorten my life to under six months.The nearby blood vessel is narrowed by 4 millimeters or more.I have at least one open and usable vein or artery in my leg, neck, or near my heart.Your blood vessels are either too big or too small for the balloon used in the study.A blood vessel next to the narrowed area measures 4 millimeters or more.I need treatment for a narrowing in my heart's aorta or pulmonary artery.I have a genetic condition linked to blood vessel issues.I am allergic to aspirin or heparin and cannot take similar medications.
- Group 1: All treated
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many individuals are participating in this trial?
"The trial necessitates 42 volunteers, who meet the outlined criteria, to partake. Patients may take part at Le Bonheur Children's in Memphis or Boston Children's in Massachusetts."
What objectives has this research endeavor been designed to fulfill?
"According to Renata Medical, the primary objective being measured over a short-term period is Primary Efficacy Endpoint. In addition to this key metric, they will be monitoring Preserved vascular patency and gradient reduction at 30 days, Successful stent re-dilation (when applicable) during re-catheterization which requires an increase in luminal diameter within 2 mm of adjacent native vessel size post dilatation, and freedom from non-elective catheter or surgical treatments for targeted stenosis within 6 months while excluding any necessary stent redilations due to patient growth."
Is the research team currently looking for participants?
"Affirmative. According to the data hosted on clinicaltrials.gov, this clinical trial is actively recruiting participants and was originally posted on January 14th 2021 before being updated last October 24th 2022. 42 patients are needed across 7 sites for enrolment into this study."
To what extent are hospitals engaging in this research endeavor?
"Patients may be accepted at Le Bonheur Children's in Memphis, Boston Children's in Massachusetts and Cedars-Sinai Medical Center in Los Angeles. Additionally, recruitment is underway at 7 other facilities across the nation."
Who else is applying?
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What portion of applicants met pre-screening criteria?
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