GROWTH: A Multicenter Pivotal Study of Neonatal, Infant, and Young Child Vascular Stenoses Studying the Renata Minima Stent
Phase: NA
Conditions: Coarctation of the Aorta, Pulmonary Artery Stenosis
Sponsor: Renata Medical

Renata Medical 
PTC-0009 
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PURPOSEFUL DEVICES FOR UNMET PEDIATRIC NEEDS 
GROWTH 
Version C 
07-November-2022
GROWTH: A Multicenter Pivotal Study of Neonatal, 
Infant, and Young Child Vascular Stenoses Studying the 
Renata Minima Stent 
Clinical Protocol 
Protocol Number: PTC-0009 
NCT Number: NCT05086016
Version C 
11/07/2022 
Study Sponsor: Renata Medical 
Proprietary - Uncontrolled if Printed 

Renata Medical 
PTC-0009 
Version C 
07-November-2022
Protocol Synopsis 
Protocol Number 
Title 
Phase 
Sponsor 
Investigational Device 
Study Objectives 
Study Design 
Study Population 
Inclusion 
PTC-0009 
Multi center Pivotal Study of Neonate, Infant, and Young Child 
Vascular Stenoses Studying the Renata Minima Stent 
Pivotal Study 
Renata Medical 
Minima Stent 
To assess device performance and clinical safety and effectiveness of 
the Minima Stent in neonates, infants and young children requiring 
intervention for coarctation of the aorta or pulmonary artery stenosis 
who are indicated for treatment. 
Single arm, prospective, non-randomized, multi-center, open-label, 
Pivotal study. 
The study population will be comprised of patients with a clinically 
relevant pulmonary artery or aortic vascular stenosis who are indicated 
for treatment. For each treatment location (pulmonary artery or aortic 
vascular), a minimum of 10 patients will be treated. 
Inclusion criteria include: 
Criteria 
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
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Requiring treatment* of:
0 
native, acquired, or recurrent aortic coarctation, or 
0 
native, acquired, or recurrent pulmonary artery stenosis 
* As defined by the patient's medical team
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Patency of at least one femoral vein, femoral artery, jugular vein
or both carotid arteries able to accommodate the delivery system
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Adjacent vessel to stenosis measuring > or equal to 4 mm
Exclusion Criteria 
Exclusion criteria include: 
•
Active bloodstream infection requiring antibiotic therapy within
3 days prior to stent implantation
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Renata Medical 
PTC-0009 
Number of Subjects 
Number of Study Sites 
Location of Study Sites 
Visit Schedule 
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07-November-2022
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 
Maximum of 42 US subjects 
8 US sites, with the possibility of additional Japanese and/or European 
Union sites pending the appropriate regulatory approvals. 
Children's Hospital Los Angeles 
Cedars Sinai Medical Center 
Seattle Children's Hospital 
Cincinnati Children's Hospital 
Boston Children's Hospital 
Nationwide Children's Hospital 
Le Bonheur Children's Hospital 
Screening/baseline, discharge, 1 month, 3 months, 6 months, 12 
months, and annually thereafter through 5 years 
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Renata Medical 
PTC-0009 
Primary Efficacy Endpoint 
Primary Safety Endpoint 
Secondary Efficacy 
Endpoints 
Secondary Safety Endpoints 
Version C 
07-November-2022
Enrollment is expected to take up to 6 months and will be ongoing 
throughout the study. 
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 defmed as: 
• Stenosis relief, defined by stent outer diameter 2: 7 5% 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 2: 50% of post-implant diameter
at 6 months; as measured using CT angiography and/or angiography.
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: 
o
Death
o
Cardiac arrest and/or emergency ECMO cannulation
o
Stroke
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Limb loss
o
Vessel dissection of target lesion
o
Device thrombosis/occlusion
o
Cardiac perforation requiring percutaneous or open surgical
intervention
o
Persistent cardiac arrhythmia requiring a pacemaker
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Peak-to-peak pressure gradient (ventricle to arterial or arterial
to arterial) < 20 mmHg after stent placement, when applicable.
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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.
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Freedom from stent embolization or migration through 6
months.
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Freedom from stent fracture that led to reintervention through 6
months
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Freedom from non-elective Minima Stent explant at 90-days
post re-dilation
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Freedom from procedure- or device-related SAE during re­
dilation that results in the following:
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Death
o
Cardiac arrest and/or emergency ECMO cannulation
o
Stroke
o
Limb loss
o
Vessel dissection of target lesion
Proprietary - Uncontrolled if Printed 

Renata Medical 
PTC-0009 
o
Device thrombosis/occlusion
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07-November-2022
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Cardiac perforation requiring percutaneous or open surgical
intervention
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Persistent cardiac arrhythmia requiring a pacemaker
Sample Size Considerations 
The study intends to enroll a maximum of 42 subjects within the
United States. For each treatment location (pulmonary artery or aortic 
vascular), a minimum of 10 patients will be treated. Additionally, no 
site will be permitted to enroll more than one third of the total subjects 
implanted in the study. 
The chosen sample size is appropriate, as it allows for the analysis of 
each co-primary endpoint, with the appropriate power level. See 
section 10 for details. 
Statistical Analysis Methods Descriptive statistics will be the primary analysis method. The
proportion of subjects with device success will be calculated along 
with the associated 95% confidence interval. Other categorical 
endpoints will be described with percentages. Continuous variables 
will be presented as mean with the standard deviation or median. 
Time-to-event endpoints will be described with Kaplan Meier graphs 
as appropriate. 
Other statistical analysis methods and graphing methods can be used 
in addition to those listed above, as appropriate. 
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