OPN Balloon for SAFE Recanalization of Calcified Coronary Lesions
Recruiting
Observational Study
Coronary Arterial Disease (CAD)
In Stent Restenosis
Calcified Coronary Lesions
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 300 (estimated)
- Sponsor
- Minneapolis Heart Institute Foundation · Other
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About This Trial
The goal of the OPEN-SAFE registry is to describe the contemporary use and outcomes of SIS-OPN in North America.
Trial Locations
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Eligibility Criteria
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 …
Contacts