OPN Balloon for SAFE Recanalization of Calcified Coronary Lesions
NCT07646444 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300
Last updated 2026-08-10
Summary
The goal of the OPEN-SAFE registry is to describe the contemporary use and outcomes of SIS-OPN in North America.
Conditions
- Coronary Arterial Disease (CAD)
- In Stent Restenosis
- Calcified Coronary Lesions
Interventions
- DEVICE
-
non compliant balloon
This is a registry tracking the use and outcomes of the OPN NC balloon, a non-compliant balloon
Sponsors & Collaborators
-
Minneapolis Heart Institute Foundation
lead OTHER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-08-31
- Primary Completion
- 2027-01-31
- Completion
- 2027-06-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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