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Stent

Catheterized Stenting for Heart Problems

N/A
Waitlist Available
Research Sponsored by Renata Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Requiring treatment of native, acquired, or recurrent aortic coarctation, or native, acquired, or recurrent pulmonary artery stenosis as defined by the patient's medical team
Patency of at least one femoral vein, femoral artery, jugular vein or both carotid arteries able to accommodate the delivery system
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

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.

Who is the study for?
This trial is for young patients needing treatment for certain heart vessel narrowings like aortic coarctation or pulmonary artery stenosis. They must have specific measurements of adjacent vessels and accessible veins or arteries for the procedure. Exclusions include hypersensitivity to certain drugs, active infections, aneurysms at the treatment site, very low body weight, multiple vessel conditions requiring stents simultaneously, and severe non-cardiac diseases.Check my eligibility
What is being tested?
The Growth Trial evaluates the safety and effectiveness of the Renata Minima Stent in neonates, infants, and children with congenital vascular stenosis. The study involves catheterized stenting to open narrowed blood vessels in these young patients.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include reactions to materials in the stent (like cobalt-chromium), complications from antiplatelet/antithrombotic medications if aspirin or heparin are used post-procedure, and general risks associated with catheterization such as bleeding or infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I need treatment for a narrowing in my heart's aorta or pulmonary artery.
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I have at least one open and usable vein or artery in my leg, neck, or near my heart for treatment delivery.
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I have at least one open and usable vein or artery in my leg, neck, or near my heart.
Select...
I need treatment for a narrowing in my heart's aorta or pulmonary artery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Efficacy Endpoint
Primary Safety Endpoint
Secondary outcome measures
Arterial to arterial peak-to-peak pressure gradient to < 20 mmHg
Successful stent re-dilation at re-catheterization
Other outcome measures
SAFETY: Free from Stent Fracture
Equipment Safety
SAFETY: Free from stent embolization or migration
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: All treatedExperimental Treatment1 Intervention
The All Treated (AT) population is defined as all subjects who signed informed consent, meet eligibility criteria and for whom a procedure was begun (defined as the initiation of vascular access with the Renata Minima system).

Find a Location

Who is running the clinical trial?

Renata MedicalLead Sponsor

Media Library

Minima Stent (Stent) Clinical Trial Eligibility Overview. Trial Name: NCT05086016 — N/A
Coarctation of the Aorta Research Study Groups: All treated
Coarctation of the Aorta Clinical Trial 2023: Minima Stent Highlights & Side Effects. Trial Name: NCT05086016 — N/A
Minima Stent (Stent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05086016 — N/A

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What site did they apply to?
Children's Hospital Los Angeles
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I need my son to be cured of coA he is 16 we just found out of the condition as he was the donor for his brothers bone marrow transplant.
PatientReceived no prior treatments
~0 spots leftby Mar 2024