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Growth Trial: Study of the Renata Minima Stent

Primary Purpose

Coarctation of the Aorta, Pulmonary Artery Stenosis

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Catheterized Stenting
Sponsored by
Renata Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coarctation of the Aorta

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospital Los Angeles
  • Cedars-Sinai Medical Center
  • Boston Children's
  • Cincinnati Children's Hospital
  • Nationwide Children's
  • Le Bonheur Children's
  • Seattle Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All treated

Arm Description

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).

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

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.
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.

Full Information

First Posted
October 7, 2021
Last Updated
October 4, 2023
Sponsor
Renata Medical
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1. Study Identification

Unique Protocol Identification Number
NCT05086016
Brief Title
Growth Trial: Study of the Renata Minima Stent
Official Title
GROWTH: A Multicenter Pivotal Study of Neonatal, Infant, and Young Child Vascular Stenoses Studying the Renata Minima Stent
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 14, 2021 (Actual)
Primary Completion Date
March 30, 2024 (Anticipated)
Study Completion Date
March 30, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Renata Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coarctation of the Aorta, Pulmonary Artery Stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
All treated
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Catheterized Stenting
Intervention Description
Catheterized stenting of vascular narrowings.
Primary Outcome Measure Information:
Title
Primary Efficacy Endpoint
Description
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.
Time Frame
Through 6-month follow-up Visit
Title
Primary Safety Endpoint
Description
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
Time Frame
Through 6-month follow-up Visit
Secondary Outcome Measure Information:
Title
Arterial to arterial peak-to-peak pressure gradient to < 20 mmHg
Description
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.
Time Frame
immediately after deployment
Title
Successful stent re-dilation at re-catheterization
Description
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.
Time Frame
Immediately after re-dilation
Other Pre-specified Outcome Measures:
Title
SAFETY: Free from stent embolization or migration
Description
Freedom from stent embolization or migration through 6 months.
Time Frame
6 months
Title
SAFETY: Free from Stent Fracture
Description
Freedom from stent fracture that led to reintervention through 6 months
Time Frame
6 months
Title
SAFETY: Free from non-elective Minima Stent explant at 90-days post re-dilation
Description
Freedom from non-elective Minima Stent explant at 90-days post re-dilation
Time Frame
90 days post re-dilation
Title
SAFETY: Freedom from procedure- or device-related SAE during re-dilation
Description
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
Time Frame
Through 6-month follow-up Visit

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Children's Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Boston Children's
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Cincinnati Children's Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Nationwide Children's
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
Le Bonheur Children's
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Growth Trial: Study of the Renata Minima Stent

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