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NCT Number: NCT05086016

Growth Trial: Study of the Renata Minima Stent

The objective of the clinical investigation is to access clinical safety and effectiveness of the Minima Stent in neonates, infants, and young children requiring intervention for common congenital vascular stenosis (i.e., coarctation of the aorta and/or pulmonary artery stenosis) who are indicated for treatment.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cedars-Sinai Medical Center, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

include:

  • The subject's legally authorized representative has been informed of the nature of the clinical investigation, agrees to its provisions, and has provided written informed consent
  • Requiring treatment* of:
  • native, acquired, or recurrent aortic coarctation, or
  • native, acquired, or recurrent pulmonary artery stenosis *As defined by the patient's medical team
  • Patency of at least one femoral vein, femoral artery, jugular vein or both carotid arteries able to accommodate the delivery system
  • Adjacent vessel to stenosis measuring > or equal to 4 mm

Exclusion criteria

include:

  • 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 pre-medicated

Treatment and study plan

Catheterized Stenting

Device

Catheterized stenting of vascular narrowings.

Primary outcomes

  1. Number of Participants Demonstrating Clinical Success at 6 Months

    Time frame: Through 6-month follow-up Visit

    The primary efficacy endpoint will be assessed as the rate of clinical success, with the performance goal defined as a clinical success rate of greater than 77%.

    Clinical success is defined as:

    • Stenosis relief, defined by stent outer diameter ≥ 75% of the surrounding vessel immediately after deployment.
    • Freedom from open surgical intervention required to treat Minima Stent disfunction through 6 months.
    • Maintenance of stented vessel diameter ≥ 50% of post-implant diameter at 6 months; as measured using CT angiography and/or angiography.

  2. Number of Participants With Freedom From Serious Adverse Events at 6 Months

    Time frame: Through 6-month follow-up Visit

    The primary safety endpoint will be assessed as the percentage of cases with freedom from procedure- or device-related SAEs resulting in an event listed below, with the performance goal defined as greater than 78% of cases:

    • 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. Number of Patients With Arterial to Arterial Peak-to-peak Pressure Gradient of < 20 mmHg

    Time frame: immediately after deployment

    When a pressure gradient provides a reliable hemodynamic variable (e.g., coarctation of the aorta), a reduction in ventricle to arterial or arterial to arterial peak-to-peak pressure gradient to < 20 mmHg after stent placement.

  2. Successful Stent Re-dilation at Re-catheterization

    Time frame: Immediately after re-dilation

    Successful stent re-dilation (when indicated) at re-catheterization, defined as an increase in the intra stent angiographic luminal diameter within 2mm of the adjacent native vessel diameter immediately after re-dilation.

  3. Number of Patients With Freedom From Stent Embolization or Migration at 6 Months

    Time frame: 6 months

    Freedom from stent embolization or migration through 6 months.

  4. Number of Patients With Freedom From Stent Fracture at 6 Months

    Time frame: 6 months

    Freedom from stent fracture that led to reintervention through 6 months

  5. Number of Patients With Freedom From Non-elective Minima Stent Explant at 90-days Post Re-dilation

    Time frame: 90 days post re-dilation

    Freedom from non-elective Minima Stent explant at 90-days post re-dilation procedure

  6. Number of Patients With Freedom From Procedure- or Device-related SAE During Re-dilation

    Time frame: Immediately after re-dilation

    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

Sponsors and collaborators

Lead sponsor

Renata Medical

Industry

Registry information

Official study title

GROWTH: A Multicenter Pivotal Study of Neonatal, Infant, and Young Child Vascular Stenoses Studying the Renata Minima Stent

Important dates

Study start
2021
Primary completion
2024
Study completion
2028
First posted
Oct 20, 2021
Registry last updated
Mar 25, 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.

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