Post-Approval Study of the Renata Minima Stent in the Treatment of Vascular Stenoses in Neonates, Infants, and Small Children
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 15
- Primary Endpoint
- Rate of Acute Device Success
Study Overview
Brief 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.
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
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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 premedicated
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Rate of Successful Stent Re-Dilation and Peak-to-Peak Pressure gradient(During and end of procedure)
- Rate of Participants with Freedom from Stent Migration/Embolization, procedure- or device- related SAEs, and non-elective stent explant(During and at end of procedure)