Recruiting

Renata Minima Stent

Sponsor:

Renata Medical

Code:

NCT06828770

Conditions

Pulmonary Artery Stenosis

Aortic Coarctation

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Minima Stent System

Study Details

Brief summary:

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.

Conditions

Pulmonary Artery Stenosis

Aortic Coarctation

Study ID

NCT06828770

Start date

May 21, 2025

Status verified date

Oct, 2025

Completion date

Dec, 2031

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Minima PAS Patients

Those treated with the Renata Minima Stent System

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Renata Medical Clinical & Regulatory Affairs

855-318-4988dali@renatamedical.com

Renata Medical Corporate

949-478-0539

Locations

Children's Hospital Los Angeles

Recruiting

Los Angeles, California, United States, 90027

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Nicklaus Children's Hospital

Recruiting

Miami, Florida, United States, 33155

Children's Healthcare of Atlanta

Recruiting

Atlanta, Georgia, United States, 30329

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

Recruiting

Chicago, Illinois, United States, 60611

Riley Hospital for Children at Indiana University Health

Recruiting

Indianapolis, Indiana, United States, 46202

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Washington University

Recruiting

Saint Louis, Michigan, United States, 63130

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Nationwide Children's Hospital

Recruiting

Columbus, Ohio, United States, 43205

UPMC Children's Hospital of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

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

Recruiting

Austin, Texas, United States, 78723

Columbia Hospital at Medical City Dallas Hospital

Recruiting

Dallas, Texas, United States, 75230

UVA Health Children's Hospital

Recruiting

Charlottesville, Virginia, United States, 22903

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

More Information

Sponsor

Renata Medical

Last update posted

Oct 23, 2025

Last verified

Oct, 2025

Keywords

  • Vascular Stenosis
  • Minima
  • Minima Stent
  • Minima Stent System
  • Renata Medical
  • Renata
  • infant stent

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Renata Medical on 2025-10-23.