Growth Trial: Study of the Renata Minima Stent

GROWTH: A Multicenter Pivotal Study of Neonatal, Infant, and Young Child Vascular Stenoses Studying 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Coarctation of the Aorta; Pulmonary Artery Stenosis
• Intervention / Treatment: Device: Catheterized Stenting

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jordan Roy; Phone Number: 8015569954; Email: jordan@renatamedical.com

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
    • Los Angeles, California, United States, 90027
      • Children's Hospital Los Angeles
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's
  • Tennessee
    • Memphis, Tennessee, United States, 38103
      • Le Bonheur Children's
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Children's Hospital

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All treated; The All Treated (AT) population is defined as all subjects who signed informed consent, meet eligibility criteria and for whom a procedure was begun (defined as the initiation of vascular access with the Renata Minima system).	Device: Catheterized Stenting; Catheterized stenting of vascular narrowings.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Efficacy Endpoint	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.	Through 6-month follow-up Visit
Primary Safety Endpoint	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	Through 6-month follow-up Visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial to arterial peak-to-peak pressure gradient to < 20 mmHg	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.	immediately after deployment
Successful stent re-dilation at re-catheterization	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.	Immediately after re-dilation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
SAFETY: Free from stent embolization or migration	Freedom from stent embolization or migration through 6 months.	6 months
SAFETY: Free from Stent Fracture	Freedom from stent fracture that led to reintervention through 6 months	6 months
SAFETY: Free from non-elective Minima Stent explant at 90-days post re-dilation	Freedom from non-elective Minima Stent explant at 90-days post re-dilation	90 days post re-dilation
SAFETY: Freedom from procedure- or device-related SAE during 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	Through 6-month follow-up Visit

Collaborators and Investigators

• Sponsor: Renata Medical

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2021
• Primary Completion (Estimated): March 30, 2024
• Study Completion (Estimated): March 30, 2028

Study Registration Dates

• First Submitted: October 7, 2021
• First Submitted That Met QC Criteria: October 7, 2021
• First Posted (Actual): October 20, 2021

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 4, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases; Congenital Abnormalities; Pathological Conditions, Anatomical; Heart Defects, Congenital; Cardiovascular Abnormalities; Constriction, Pathologic; Aortic Coarctation; Stenosis, Pulmonary Artery
• Other Study ID Numbers: PTC-0009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes