Minima Stent System Post- Approval Study (PAS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Coarctation; Pulmonary Artery Stenosis
• Intervention / Treatment: Device: Minima Stent System

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Renata Medical Clinical & Regulatory Affairs; Phone Number: 6 855-318-4988; Email: dali@renatamedical.com
• Study Contact Backup: Name: Renata Medical Corporate; Phone Number: 949-478-0539

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90027
      • Recruiting
      • Children's Hospital Los Angeles
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • Children's Hospital Colorado
  • Florida
    • Miami, Florida, United States, 33155
      • Recruiting
      • Nicklaus Children's Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Recruiting
      • Children's Healthcare of Atlanta
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Ann & Robert H. Lurie Children's Hospital of Chicago
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • Riley Hospital for Children at Indiana University Health
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Boston Children's Hospital
  • Michigan
    • Saint Louis, Michigan, United States, 63130
      • Recruiting
      • Washington University
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Recruiting
      • Cincinnati Children's Hospital Medical Center
    • Columbus, Ohio, United States, 43205
      • Recruiting
      • Nationwide Children's Hospital
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • Recruiting
      • UPMC Children's Hospital of Pittsburgh
  • Texas
    • Austin, Texas, United States, 78723
      • Recruiting
      • Dell Children's Medical Center, The University of Texas at Austin
    • Dallas, Texas, United States, 75230
      • Recruiting
      • Columbia Hospital at Medical City Dallas Hospital
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • Recruiting
      • UVA Health Children's Hospital
  • Washington
    • Seattle, Washington, United States, 98105
      • Recruiting
      • Seattle Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients treated with the Renata Minima Stent System in the United States

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Minima PAS Patients; Those treated with the Renata Minima Stent System	Device: Minima Stent System; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Acute Device Success	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	End of Procedure (Following Implantation of the Stent)
Rate of Participants with Freedom from procedure- or device-related SAEs	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	Immediately after Postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Successful Stent Re-Dilation and Peak-to-Peak Pressure gradient	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).	During and end of procedure
Rate of Participants with Freedom from Stent Migration/Embolization, procedure- or device- related SAEs, and non-elective stent explant	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:DeathCardiac arrest and/or emergency ECMO cannulationStrokeLimb lossVessel dissection of target lesionDevice thrombosis/occlusionCardiac perforation requiring percutaneous or open surgical interventionPersistent cardiac arrhythmia requiring a pacemaker	During and at end of procedure

Collaborators and Investigators

• Sponsor: Renata Medical
• Investigators: Principal Investigator: Arash Salavitabar, MD, Nationwide Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): December 1, 2031

Study Registration Dates

• First Submitted: February 3, 2025
• First Submitted That Met QC Criteria: February 11, 2025
• First Posted (Actual): February 14, 2025

Study Record Updates

• Last Update Posted (Estimated): October 23, 2025
• Last Update Submitted That Met QC Criteria: October 21, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Vascular Stenosis; Minima; Minima Stent; Minima Stent System; Renata Medical; Renata; infant stent
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Defects, Congenital; Arterial Occlusive Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Stenosis, Pulmonary Artery; Aortic Coarctation
• Other Study ID Numbers: PTC-0038

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes