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Minima Stent System for Pulmonary Artery Stenosis or Aortic Coarctation

This study is observing how well the Minima Stent System works in real-world use for patients with pulmonary artery stenosis (narrowing of the artery to the lungs) or aortic coarctation (narrowing of the main artery from the heart). The Minima Stent System is a device used to treat these conditions in babies and children weighing at least 1.5kg. Researchers want to see the rate of successful stent placement and how many patients avoid serious problems related to the procedure or device. You may be able to join if your doctor determines you need treatment with the Minima Stent System and you do not have an active bloodstream infection. This study plans to enroll at least 100 participants and is currently recruiting.

Study design
This is an observational study, meaning researchers will watch how the Minima Stent System is used in real-world settings. It is a single-arm, multi-center study, planning to enroll at least 100 participants.
What's involved
You would have follow-up visits immediately after the stent is implanted, during any re-dilation procedures, annually, and at other standard doctor visits for up to 5 years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed immediately after the procedure, during re-dilation procedures, annually, and at other standard doctor visits for up to 5 years after the stent is implanted.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06828770

Minima Stent System Post- Approval Study (PAS)

Recruiting
Not specifiedAll AgesObservational
Renata Medical
~100 participants
Updated 2025-10-23 on ClinicalTrials.gov
What's tested:Minima Stent System

At a glance

Recruiting sites
15 of 15 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of Acute Device Success
Measured over End of Procedure (Following Implantation of the Stent)
+1 more outcome measured

Conditions

Pulmonary Artery Stenosis
Aortic Coarctation

Explore related trials

Aortic CoarctationPulmonary Artery StenosisVascular Stenosis

NCT06828770

Where you'd take part

This study runs at 15 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Ann & Robert H. Lurie Children's Hospital of Chicago

    Chicago, Illinoisno site contact published

    Recruiting

  • Boston Children's Hospital

    Boston, Massachusettsno site contact published

    Recruiting

  • Children's Healthcare of Atlanta

    Atlanta, Georgiano site contact published

    Recruiting

  • Children's Hospital Colorado

    Aurora, Coloradono site contact published

    Recruiting

  • Children's Hospital Los Angeles

    Los Angeles, Californiano site contact published

    Recruiting

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohiono site contact published

    Recruiting

  • Columbia Hospital at Medical City Dallas Hospital

    Dallas, Texasno site contact published

    Recruiting

  • Dell Children's Medical Center, The University of Texas at Austin

    Austin, Texasno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Arash Salavitabar, MD · PRINCIPAL_INVESTIGATOR · Nationwide Children's Hospital

Who to contact

Renata Medical Clinical & Regulatory Affairs
[email protected]
855-318-4988 · ext. 6
Email the study team

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Eligibility criteria

Inclusion

The subject's legally authorized representative has been informed of the nature of the device treatment, agrees to its provisions, and has provided written informed consent
Indicated for treatment with the Minima Stent System per the IFU.

Exclusion

Active bloodstream infection requiring antibiotic therapy within 3 days prior to stent implantation
History of or active endocarditis (active treatment with antibiotics) within 180 days prior to stent implantation
Aortic or pulmonary artery aneurysm in the location targeted for treatment
Body weight \< 1.5 kg
Anatomic location of lesion judged by the investigator to not lend to the safe placement of a stent
Target vessels larger or smaller than the Minima System balloon size ranges
Known genetic syndrome known to be associated with vasculopathies such as but not limited to Williams syndrome, Loeys-Dietz syndrome, etc
Clinical scenario requiring that more than one vessel needs stent implantation at the time of the trial procedure.
Currently participating in an investigational drug study or another device study
Major or progressive non-cardiac disease resulting in a life expectancy of less than six months
Known hypersensitivity to aspirin or heparin and cannot be treated with other antiplatelet and/or antithrombotic medications
Known hypersensitivity to cobalt-chromium or contrast media that cannot be adequately premedicated

What this trial measures

  • Rate of Acute Device SuccessEnd of Procedure (Following Implantation of the Stent)

    Rate of Acute device success as defined by: * Stenosis relief, defined by stent outer diameter ≥ 75% of the normal surrounding vessel immediately after deployment. * Freedom from open surgical intervention required to treat Minima Stent dysfunction at implantation

  • Rate of Participants with Freedom from procedure- or device-related SAEsImmediately after Postoperative

    Rate of Participants with Freedom from procedure- or device-related SAEs resulting in an event listed below: * Death * Cardiac arrest and/or emergency ECMO cannulation * Stroke * Limb loss * Vessel dissection of target lesion * Device thrombosis/occlusion * Cardiac perforation requiring percutaneous or open surgical intervention * Persistent cardiac arrhythmia requiring a pacemaker