Coarctation of the Aorta, Pulmonary Artery Stenosis
Conditions
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.
Interventions
DEVICECatheterized Stenting
Catheterized stenting of vascular narrowings.
Sponsors
Renata Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Demonstrating Clinical Success at 6 Months | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Freedom From Stent Embolization or Migration at 6 Months | 6 months | Freedom from stent embolization or migration through 6 months. |
| Number of Patients With Freedom From Stent Fracture at 6 Months | 6 months | Freedom from stent fracture that led to reintervention through 6 months |
| Number of Patients With Arterial to Arterial Peak-to-peak Pressure Gradient of < 20 mmHg | immediately after deployment | 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. |
| Number of Patients With Freedom From Procedure- or Device-related SAE During Re-dilation | Immediately after 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 |
| Number of Patients With Freedom From Non-elective Minima Stent Explant at 90-days Post Re-dilation | 90 days post re-dilation | Freedom from non-elective Minima Stent explant at 90-days post re-dilation procedure |
| Successful Stent Re-dilation at Re-catheterization | Immediately after re-dilation | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Treated 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). | 42 |
| Total | 42 |
Baseline characteristics
| Characteristic | All Treated |
|---|---|
| Age, Continuous | 9 months |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants |
| Race (NIH/OMB) White | 22 Participants |
| Region of Enrollment United States | 42 Participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 42 |
| other Total, other adverse events | 5 / 42 |
| serious Total, serious adverse events | 0 / 42 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Treated | Number of Participants Demonstrating Clinical Success at 6 Months | 41 Participants |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Treated | Number of Participants With Freedom From Serious Adverse Events at 6 Months | 42 Participants |
Secondary
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
Population: Patients with a Minima Stent deployed in the aortic circulation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Treated | Number of Patients With Arterial to Arterial Peak-to-peak Pressure Gradient of < 20 mmHg | 21 Participants |
Secondary
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
Population: 20 re-dilation procedures (14 post-initial re-dilation and 6 post-second re-dilation) across 14 subjects that have reached the 90 days post re-dilation procedure endpoint for assessment
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| All Treated | Number of Patients With Freedom From Non-elective Minima Stent Explant at 90-days Post Re-dilation | 20 Stent Re-Dilation Procedures |
Secondary
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
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| All Treated | Number of Patients With Freedom From Procedure- or Device-related SAE During Re-dilation | 21 Stent Re-Dilation Procedures |
Secondary
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
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| All Treated | Number of Patients With Freedom From Stent Embolization or Migration at 6 Months | 42 Stent Implants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Treated | Number of Patients With Freedom From Stent Fracture at 6 Months | 42 Participants |
Secondary
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
Population: 15 patients have had at least one re-dilation with a total of 15 initial re-dilations and 6 second re-dilations (21 total re-dilations).
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| All Treated | Successful Stent Re-dilation at Re-catheterization | 19 Stent Re-Dilation Procedures |