Minima Stent System Post- Approval Study (PAS)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorRenata Medical
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial population
Patients treated with the Renata Minima Stent System in the United States
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Minima Stent System
DeviceMinima 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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Minima PAS Patients1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
End of Procedure (Following Implantation of the Stent)2
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
Time frame
Immediately after PostoperativeSecondary outcomes
1
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).
Time frame
During and end of procedure2
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
Time frame
During and at end of procedureSponsors and contacts
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Source ClinicalTrials.gov