Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06828770

Minima Stent System Post- Approval Study (PAS)

This Post-Approval Study is a single arm, prospective, multi-center, open-label study of patients treated with the Renata Minima Stent System in the United States. The objective of the study is to continue the assessment of device performance and capture outcome data on use of the device in real-world use.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Pulmonary Artery Stenosis Aortic Coarctation Arterial Occlusive Diseases Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Stenosis, Pulmonary Artery Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital Los Angeles, Los Angeles, California, United States

Loading trial locations.

About this study

A minimum of 100 subjects will be enrolled. Follow-up will occur immediately after the initial implant procedure, at subsequent re-dilation procedures, annually, and at any additional standard of care follow-up visits (determined by the implanting physician) through 5 years post-implant. Data collected at each follow-up will be used in analysis. This study will monitor key data points related to the device and procedure.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Minima Stent System

Device

Minima Stent System is indicated for use in the treatment of native or acquired pulmonary artery stenoses or coarctation of the aorta in neonates, infants, and children at least 1.5kg in weight.

Primary outcomes

  1. Rate of Acute Device Success

    Time frame: End 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

  2. Rate of Participants with Freedom from procedure- or device-related SAEs

    Time frame: Immediately 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

Secondary outcomes

  1. Rate of Successful Stent Re-Dilation and Peak-to-Peak Pressure gradient

    Time frame: During and end of procedure

    • Peak-to-peak pressure gradient (ventricle to arterial or arterial to arterial) < 20 mmHg after stent placement, in treatment of Aortic Coarctation, when applicable.
    • Successful stent re-dilation (when indicated) at recatheterization, defined as angiographic improvement of stenosis to >50% of the normal surrounding vessel.
    • Maintenance of stented vessel diameter ≥ 50% of post implant diameter at the time of re-dilation (pre re-dilation).

  2. Rate of Participants with Freedom from Stent Migration/Embolization, procedure- or device- related SAEs, and non-elective stent explant

    Time frame: During and at end of procedure

    • Freedom from intraprocedural stent movement to non-intended location during the procedure.
    • Freedom from postprocedural stent embolization or migration
    • Freedom from stent fracture that led to reintervention
    • Freedom from non-elective Minima Stent explant
    • Freedom from procedure- or device-related SAE during re-dilation that results in the following:
    • 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

Study contacts

Contact information is provided by the study sponsor or research team.

Renata Medical Clinical & Regulatory Affairs

CONTACT

[email protected]

855-318-4988 ext. 6

Renata Medical Corporate

CONTACT

949-478-0539

Sponsors and collaborators

Lead sponsor

Renata Medical

Industry

Registry information

Official study title

Post-Approval Study of the Renata Minima Stent in the Treatment of Vascular Stenoses in Neonates, Infants, and Small Children

Important dates

Study start
2025
Primary completion
2027
Study completion
2031
First posted
Feb 14, 2025
Registry last updated
Oct 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.