Pulmonary Artery StenosisNCT06828770
Minima Stent System Post- Approval Study (PAS)
An observational study of Pulmonary Artery Stenosis and Aortic Coarctation, run by Renata Medical at 15 sites in United States.
Trial summary
This Post-Approval Study is a single arm, prospective, multi-center, open-label study of patients treated with the Renata Minima Stent System in the United States. The objective of the study is to continue the assessment of device performance and capture outcome data on use of the device in real-world use. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Artery Stenosis, Aortic Coarctation
- What is being tested?
- Minima Stent System
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 15 sitesUnited States
- Study dates
- 21 May 2025to Dec 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients treated with the Renata Minima Stent System in the United States
Who may be able to join
- The subject's legally authorized representative has been informed of the nature of the device treatment, agrees to its provisions, and has provided written informed consent
- Indicated for treatment with the Minima Stent System per the IFU.
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 premedicated
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Renata Medical Corporate contact
15 sites in 1 country
United States15 sites, 15 recruiting
- Recruiting
Children's Healthcare of Atlanta
Atlanta, Georgia, 30329
- Recruiting
Children's Hospital Colorado
Aurora, Colorado, 80045
- Recruiting
Dell Children's Medical Center, The University of Texas at Austin
Austin, Texas, 78723
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
- Recruiting
UVA Health Children's Hospital
Charlottesville, Virginia, 22903
- Recruiting
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
- Recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205
- Recruiting
Columbia Hospital at Medical City Dallas Hospital
Dallas, Texas, 75230
- Recruiting
Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana, 46202
- Recruiting
Children's Hospital Los Angeles
Los Angeles, California, 90027
- Recruiting
Nicklaus Children's Hospital
Miami, Florida, 33155
- Recruiting
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
- Recruiting
Washington University
Saint Louis, Michigan, 63130
- Recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
About this study
Official title: Post-Approval Study of the Renata Minima Stent in the Treatment of Vascular Stenoses in Neonates, Infants, and Small Children
This Post-Approval Study is a single arm, prospective, multi-center, open-label study of patients treated with the Renata Minima Stent System in the United States. The objective of the study is to continue the assessment of device performance and capture outcome data on use of the device in real-world use.
Read the detailed description
A minimum of 100 subjects will be enrolled. Follow-up will occur immediately after the initial implant procedure, at subsequent re-dilation procedures, annually, and at any additional standard of care follow-up visits (determined by the implanting physician) through 5 years post-implant. Data collected at each follow-up will be used in analysis. This study will monitor key data points related to the device and procedure.
- Conditions
- Pulmonary Artery Stenosis, Aortic Coarctation
- Being tested
- Minima Stent System
- Keywords
- Vascular Stenosis, Minima, Minima Stent, Minima Stent System, Renata Medical, Renata, infant stent
- Medical subject headings
- Stenosis, Pulmonary Artery, Aortic Coarctation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minima Stent SystemDevice
Minima Stent System is indicated for use in the treatment of native or acquired pulmonary artery stenoses or coarctation of the aorta in neonates, infants, and children at least 1.5kg in weight.
| Study group | Role | What they receive |
|---|---|---|
| Minima PAS Patients | Those treated with the Renata Minima Stent System Receives: Device: Minima Stent System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Acute Device Success
Rate of Acute device success as defined by:
- Stenosis relief, defined by stent outer diameter ≥ 75% of the normal surrounding vessel immediately after deployment.
- Freedom from open surgical intervention required to treat Minima Stent dysfunction at implantation
Measured: End of Procedure (Following Implantation of the Stent)
Rate of Participants with Freedom from procedure- or device-related SAEs
Rate of Participants with Freedom from procedure- or device-related SAEs resulting in an event listed below:
- 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 Postoperative
Secondary outcomes (2)
Rate of Successful Stent Re-Dilation and Peak-to-Peak Pressure gradient
- Peak-to-peak pressure gradient (ventricle to arterial or arterial to arterial) < 20 mmHg after stent placement, in treatment of Aortic Coarctation, when applicable.
- Successful stent re-dilation (when indicated) at recatheterization, defined as angiographic improvement of stenosis to >50% of the normal surrounding vessel.
- Maintenance of stented vessel diameter ≥ 50% of post implant diameter at the time of re-dilation (pre re-dilation).
Measured: During and end of procedure
Rate of Participants with Freedom from Stent Migration/Embolization, procedure- or device- related SAEs, and non-elective stent explant
- Freedom from intraprocedural stent movement to non-intended location during the procedure.
- Freedom from postprocedural stent embolization or migration
- Freedom from stent fracture that led to reintervention
- Freedom from non-elective Minima Stent explant
- 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: During and at end of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start21 May 2025
- Primary completionMay 2027 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Artery StenosisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Renata Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arash Salavitabar, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06828770
- Sponsor's protocol ID
- PTC-0038
- Status last verified
- Oct 2025
- First submitted
- 3 Feb 2025
- Last updated
- 23 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Approval Study of the Renata Minima Stent in the Treatment of Vascular Stenoses in Neonates, Infants, and Small Children
- ClinicalTrials.gov ID
- NCT06828770
- Acronym / sponsor ID
- PTC-0038
- Conditions
- Pulmonary Artery Stenosis, Aortic Coarctation
- Keywords
- Vascular Stenosis, Minima, Minima Stent, Minima Stent System, Renata Medical, Renata, infant stent
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Renata MedicalIndustry (pharma, biotech, devices)
- Study start
- 21 May 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 14 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Post-Approval Study is a single arm, prospective, multi-center, open-label study of patients treated with the Renata Minima Stent System in the United States. The objective of the study is to continue the assessment of device performance and capture outcome data on use of the device in real-world use.
Detailed description
A minimum of 100 subjects will be enrolled. Follow-up will occur immediately after the initial implant procedure, at subsequent re-dilation procedures, annually, and at any additional standard of care follow-up visits (determined by the implanting physician) through 5 years post-implant. Data collected at each follow-up will be used in analysis. This study will monitor key data points related to the device and procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Minima PAS Patients | – | Device: Minima Stent SystemThose treated with the Renata Minima Stent System |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients treated with the Renata Minima Stent System in the United States
Key inclusion criteria (2 listed)
- The subject's legally authorized representative has been informed of the nature of the device treatment, agrees to its provisions, and has provided written informed consent
- Indicated for treatment with the Minima Stent System per the IFU.
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 |
|---|---|---|
| Minima Stent SystemMinima Stent System is indicated for use in the treatment of native or acquired pulmonary artery stenoses or coarctation of the aorta in neonates, infants, and children at least 1.5kg in weight. | Device | Minima PAS Patients |
Primary outcome
Rate of Acute Device Success
Time frame: End of Procedure (Following Implantation of the Stent)
Rate of Acute device success as defined by: * Stenosis relief, defined by stent outer diameter ≥ 75% of the normal surrounding vessel immediately after deployment. * Freedom from open surgical intervention required to treat Minima Stent dysfunction at implantation
Rate of Participants with Freedom from procedure- or device-related SAEs
Time frame: Immediately after Postoperative
Rate of Participants with Freedom from procedure- or device-related SAEs resulting in an event listed below: * 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
2 secondary outcomes
Rate of Successful Stent Re-Dilation and Peak-to-Peak Pressure gradient
Time frame: During and end of procedure
Rate of Participants with Freedom from Stent Migration/Embolization, procedure- or device- related SAEs, and non-elective stent explant
Time frame: During and at end of procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2025.
- Individual participant dataSharing planned: No
Related trials for Pulmonary Artery Stenosis
Active, not recruitingObservational study
Expanded Studies on the SCAPIS Stockholm Reexamination Cohort
Coronary Artery Disease, Arterial Stiffness, Blood Pressure
RecruitingObservational study
Post-Approval Study of PALMAZ MULLINS XD™ in Treating Pulmonary Artery Stenosis
Pulmonary Artery Stenosis
Recruiting
COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction
Complex Congenital Heart Defect, Dysfunctional RVOT Conduit
Not yet recruiting
First-in-human Clinical Trial to Assess Safety and Efficacy of the CardiaZn Bioresorbable Stent in Children With Pulmonary Artery Stenosis and Aortic Coarctation
Aortic Coarctation, Pulmonary Artery Stenosis
RecruitingObservational study
Cardiovascular Risk in Children With Chronic Conditions Study
Kidney Transplant, Familial Hypercholesterolaemia
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.
Renata Medical Corporate contact
Arash Salavitabar, MD principal investigator
Nationwide Children's Hospital
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Artery Stenosis and Aortic Coarctation, run by Renata Medical at 15 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 2 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: looking for participants now, as of the sponsor's last update on 23 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Renata Medical Clinical & Regulatory Affairs (855-318-4988 ext. 6, dali@renatamedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Acute Device Success (time frame: End of Procedure (Following Implantation of the Stent)). 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?
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 23 Oct 2025.