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.
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 Type
OBSERVATIONAL
Enrollment
100
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.
Children's Hospital Los Angeles
Los Angeles, California, United States
RECRUITINGChildren's Hospital Colorado
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)
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 Postoperative
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 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
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Aurora, Colorado, United States
Nicklaus Children's Hospital
Miami, Florida, United States
RECRUITINGChildren's Healthcare of Atlanta
Atlanta, Georgia, United States
RECRUITINGAnn & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
RECRUITINGRiley Hospital for Children at Indiana University Health
Indianapolis, Indiana, United States
RECRUITINGBoston Children's Hospital
Boston, Massachusetts, United States
RECRUITINGWashington University
Saint Louis, Michigan, United States
RECRUITINGCincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
RECRUITINGNationwide Children's Hospital
Columbus, Ohio, United States
RECRUITING...and 5 more locations
Time frame: During and at end of procedure