Coarctation of the AortaNCT05086016
Growth Trial: Study of the Renata Minima Stent
A study testing Catheterized Stenting in people with Coarctation of the Aorta and Pulmonary Artery Stenosis, run by Renata Medical at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coarctation of the Aorta, Pulmonary Artery Stenosis
- What is being tested?
- Catheterized Stenting
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 7 sitesUnited States
- Study dates
- 14 Jan 2021to 30 Mar 2028
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Boston Children's
Boston, Massachusetts, 02115
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
Nationwide Children's
Columbus, Ohio, 43205
Children's Hospital Los Angeles
Los Angeles, California, 90027
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Le Bonheur Children's
Memphis, Tennessee, 38103
Seattle Children's Hospital
Seattle, Washington, 98105
About this study
Official title: 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.
- Being tested
- Catheterized Stenting
- Medical subject headings
- Aortic Coarctation, Stenosis, Pulmonary Artery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheterized StentingDevice
Catheterized stenting of vascular narrowings.
| Study group | Role | What they receive |
|---|---|---|
| All treated | Experimental | 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). Receives: Device: Catheterized Stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Demonstrating Clinical Success at 6 Months
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.
Measured: Through 6-month follow-up Visit
Number of Participants With Freedom From Serious Adverse Events at 6 Months
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
Measured: Through 6-month follow-up Visit
Secondary outcomes (6)
Number of Patients With Arterial to Arterial Peak-to-peak Pressure Gradient of < 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.
Measured: 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.
Measured: Immediately after re-dilation
Number of Patients With Freedom From Stent Embolization or Migration at 6 Months
Freedom from stent embolization or migration through 6 months.
Measured: 6 months
Number of Patients With Freedom From Stent Fracture at 6 Months
Freedom from stent fracture that led to reintervention through 6 months
Measured: 6 months
Number of Patients With Freedom 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 procedure
Measured: 90 days post re-dilation
Number of Patients With 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
Measured: Immediately after re-dilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start14 Jan 2021
- Primary completion26 Feb 2024
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coarctation of the AortaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Renata Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Darren Berman, MD, Principal investigator, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05086016
- Sponsor's protocol ID
- PTC-0009
- Status last verified
- Mar 2025
- First submitted
- 7 Oct 2021
- Last updated
- 25 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Sullivan PM, Zahn EM, Sathanandam S, Morray B, Shahanavaz S, Salavitabar A, Armstrong AK, Porras D, Berman DP. Multicenter Pivotal Trial of the Minima Stent for Vascular Stenosis in Infants and Young Children. Circ Cardiovasc Interv. 2025 Dec;18(12):e015618. doi: 10.1161/CIRCINTERVENTIONS.125.015618. Epub 2025 Oct 10.
PubMed 41070410
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GROWTH: A Multicenter Pivotal Study of Neonatal, Infant, and Young Child Vascular Stenoses Studying the Renata Minima Stent
- ClinicalTrials.gov ID
- NCT05086016
- Acronym / sponsor ID
- PTC-0009
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Renata MedicalIndustry (pharma, biotech, devices)
- Study start
- 14 Jan 2021 (actual)
- Primary completion
- 26 Feb 2024 (actual)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 20 Oct 2021 (actual)
- Results
- Posted 25 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All treated | Experimental | Device: Catheterized StentingThe 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Catheterized StentingCatheterized stenting of vascular narrowings. | Device | All treated |
Primary outcome
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.
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
6 secondary outcomes
Number of Patients With Arterial to Arterial Peak-to-peak Pressure Gradient of < 20 mmHg
Time frame: immediately after deployment
Successful Stent Re-dilation at Re-catheterization
Time frame: Immediately after re-dilation
Number of Patients With Freedom From Stent Embolization or Migration at 6 Months
Time frame: 6 months
Number of Patients With Freedom From Stent Fracture at 6 Months
Time frame: 6 months
Number of Patients With Freedom From Non-elective Minima Stent Explant at 90-days Post Re-dilation
Time frame: 90 days post re-dilation
Number of Patients With Freedom From Procedure- or Device-related SAE During Re-dilation
Time frame: Immediately after re-dilation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41070410Sullivan PM, Zahn EM, Sathanandam S, Morray B, Shahanavaz S, Salavitabar A, Armstrong AK, Porras D, Berman DP. Multicenter Pivotal Trial of the Minima Stent for Vascular Stenosis in Infants and Young Children. Circ Cardiovasc Interv. 2025 Dec;18(12):e015618. doi: 10.1161/CIRCINTERVENTIONS.125.015618. Epub 2025 Oct 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darren Berman, MD principal investigator
Children's Hospital Los Angeles
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Catheterized Stenting in people with Coarctation of the Aorta and Pulmonary Artery Stenosis, run by Renata Medical at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Demonstrating Clinical Success at 6 Months (time frame: Through 6-month follow-up Visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05086016, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.