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
Qualifiers
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 design
Treatments tested in this trial
- Minima Stent System
Treatment groups
100 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov