Catheterized Stenting for Heart Problems

Recruiting in Palo Alto (17 mi)

+6 other locations

Overseen byDarren Berman, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Renata Medical

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a small tube-like device called the Minima Stent. It is designed for babies and young children who have narrow blood vessels. The stent helps keep these vessels open, allowing better blood flow.

Research Team

Darren Berman, MD

Principal Investigator

Children's Hospital Los Angeles

Eligibility Criteria

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.

Inclusion Criteria

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.

The subject's legally authorized representative has been informed of the nature of the clinical investigation, agrees to its provisions, and has provided written informed consent

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Exclusion Criteria

You weigh less than 1.5 kilograms.

I need stents in more than one of my blood vessels.

Currently participating in an investigational drug study or another device study

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Treatment Details

Interventions

Minima Stent (Stent)

Trial OverviewThe 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.

Participant Groups

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).