An interventional study of Catheterized Stenting in Coarctation of the Aorta and Pulmonary Artery Stenosis, sponsored by Renata Medical. Active, not recruiting at 7 sites in United States. Per ClinicalTrials.gov, last updated 2025-03-25.
Sponsored by Renata Medical · Not applicable, Interventional, and Treatment
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.
49 studies on the registry are indexed under Aortic Coarctation; 16 are open to participants now.
This study's enrollment of 42 is close to the median of 45 across 19 interventional studies indexed under Aortic Coarctation.
Browse Aortic Coarctation studies →Renata Medical is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Requiring treatment* of:
Exclusion criteria include:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: 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
Time frame: Through 6-month follow-up Visit
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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months
Number of Patients With Freedom From Stent Fracture at 6 Months
Freedom from stent fracture that led to reintervention through 6 months
Time frame: 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
Time frame: 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
Time frame: Immediately after re-dilation
| Milestone | All Treated |
|---|---|
| Started | 42 |
| Completed | 42 |
| Not completed | 0 |
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.
| Participants | All Treated |
|---|---|
| Number of Participants Demonstrating Clinical Success at 6 Months | 41 |
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
| Participants | All Treated |
|---|---|
| Number of Participants With Freedom From Serious Adverse Events at 6 Months | 42 |
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.
| Participants | All Treated |
|---|---|
| Number of Patients With Arterial to Arterial Peak-to-peak Pressure Gradient of < 20 mmHg | 21 |
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.
| Stent Re-Dilation Procedures | All Treated |
|---|---|
| Successful Stent Re-dilation at Re-catheterization | 19 |
Freedom from stent embolization or migration through 6 months.
| Stent Implants | All Treated |
|---|---|
| Number of Patients With Freedom From Stent Embolization or Migration at 6 Months | 42 |
Freedom from stent fracture that led to reintervention through 6 months
| Participants | All Treated |
|---|---|
| Number of Patients With Freedom From Stent Fracture at 6 Months | 42 |
Freedom from non-elective Minima Stent explant at 90-days post re-dilation procedure
| Stent Re-Dilation Procedures | All Treated |
|---|---|
| Number of Patients With Freedom From Non-elective Minima Stent Explant at 90-days Post Re-dilation | 20 |
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
| Stent Re-Dilation Procedures | All Treated |
|---|---|
| Number of Patients With Freedom From Procedure- or Device-related SAE During Re-dilation | 21 |
Collected over Adverse Events are collected through study completion. Structured visits include at time of procedure, post-procedure/discharge, 1 month, 3 months, 6 months 12 months, and annually thereafter through 5 years.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Treated | 1/42 (2.4%) | 0/42 (0%) | 5/42 (11.9%) |
| Event | All Treated |
|---|---|
| Access Site ComplicationsInjury, poisoning and procedural complications | 5/42 |
| Age, Continuous(months) | All Treated |
|---|---|
| Median | 9 (0.4 to 112) |
| Sex: Female, Male(Participants) | All Treated |
|---|---|
| Female | 20 |
| Male | 22 |
| Race (NIH/OMB)(Participants) | All Treated |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 1 |
| Black or African American | 7 |
| White | 22 |
| More than one race | 0 |
| Unknown or Not Reported | 11 |
| Ethnicity (NIH/OMB)(Participants) | All Treated |
|---|---|
| Hispanic or Latino | 9 |
| Not Hispanic or Latino | 32 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(Participants) | All Treated |
|---|---|
| United States | 42 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2021 to primary completion in Feb 2024, 37 months.
Results were first posted in Mar 2025, 1 year after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Renata Medical