Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of the OPEN-SAFE registry is to describe the contemporary use and outcomes of SIS-OPN in North America.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| non compliant balloon | Device | This is a registry tracking the use and outcomes of the OPN NC balloon, a non-compliant balloon |
| Measure | Description | Time Frame |
|---|---|---|
| In-Hospital Outcomes | Descriptive summaries of incidence of in-hospital outcomes and MACE | periprocedural |
| Treatment Utilization | descriptive summaries of various treatments utilized before and after use of the OPN balloon | intra-procedural |
| Predictors of Success and Failure for the OPN Balloon | Assess predictors for failure of the OPN balloon | intra-procedural |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Individuals over the age of 18 who have undergone clinically indicated PCI with the use of the OPN balloon
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bavana V Rangan, BDS, MPH | Contact | 612-863-4768 | Bavana.Rangan@allina.com |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided