OPN Balloon for SAFE Recanalization of Calcified Coronary Lesions
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMinneapolis Heart Institute Foundation
About this trial
The goal of the OPEN-SAFE registry is to describe the contemporary use and outcomes of SIS-OPN in North America.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older
Subjects who underwent a clinically indicated PCI procedure that involved at least one OPN balloon
Date range for data collection will be from February 1, 2023 to December 31, 2028
Disqualifiers
Subjects who have opted out of being included in research related data collection
Trial population
Individuals over the age of 18 who have undergone clinically indicated PCI with the use of the OPN balloon
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
non compliant balloon
DeviceThis is a registry tracking the use and outcomes of the OPN NC balloon, a non-compliant balloon
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
In-Hospital Outcomes
Descriptive summaries of incidence of in-hospital outcomes and MACE
Time frame
periprocedural2
Treatment Utilization
descriptive summaries of various treatments utilized before and after use of the OPN balloon
Time frame
intra-procedural3
Predictors of Success and Failure for the OPN Balloon
Assess predictors for failure of the OPN balloon
Time frame
intra-proceduralSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov