Calcified Coronary Lesions, Coronary Arterial Disease (CAD), In Stent Restenosis
Conditions
Brief summary
The goal of the OPEN-SAFE registry is to describe the contemporary use and outcomes of SIS-OPN in North America.
Interventions
DEVICEnon compliant balloon
This is a registry tracking the use and outcomes of the OPN NC balloon, a non-compliant balloon
Sponsors
Minneapolis Heart Institute Foundation
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Subjects who have opted out of being included in research related data collection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| In-Hospital Outcomes | periprocedural | Descriptive summaries of incidence of in-hospital outcomes and MACE |
| Treatment Utilization | intra-procedural | descriptive summaries of various treatments utilized before and after use of the OPN balloon |
| Predictors of Success and Failure for the OPN Balloon | intra-procedural | Assess predictors for failure of the OPN balloon |
Countries
United States
Contacts
CONTACTBavana V Rangan, BDS, MPH
Outcome results
None listed