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NCT06828770Recruiting

Minima Stent System Post- Approval Study (PAS)

Renata Medical

Start Date

5/21/2025

Completion Date

12/1/2031

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.

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.

Eligibility Criteria

Age Range: No minimum to No maximum

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

Interventions

DEVICE

Minima Stent System

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Conditions

Pulmonary Artery StenosisAortic Coarctation

Locations

Children's Hospital Los Angeles

Los Angeles, California 90027

United States

Children's Hospital Colorado

Aurora, Colorado 80045

United States

Nicklaus Children's Hospital

Miami, Florida 33155

United States

Children's Healthcare of Atlanta

Atlanta, Georgia 30329

United States

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

Chicago, Illinois 60611

United States

Riley Hospital for Children at Indiana University Health

Indianapolis, Indiana 46202

United States

Boston Children's Hospital

Boston, Massachusetts 02115

United States

Washington University

Saint Louis, Michigan 63130

United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio 45229

United States

Nationwide Children's Hospital

Columbus, Ohio 43205

United States

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania 15224

United States

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

Austin, Texas 78723

United States

Columbia Hospital at Medical City Dallas Hospital

Dallas, Texas 75230

United States

UVA Health Children's Hospital

Charlottesville, Virginia 22903

United States

Seattle Children's Hospital

Seattle, Washington 98105

United States