OPN Balloon Use for Recanalization of Calcified Coronary Lesions
Official title: OPN Balloon for SAFE Recanalization of Calcified Coronary Lesions (OPEN-SAFE Registry)
Run by Minneapolis Heart Institute Foundation · NCT07646444 · Data updated 2026-11-12
This registry tests how the SIS-OPN balloon is used in real-world patients with calcified coronary disease who have undergone PCI in North America.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Minneapolis Heart Institute Foundation Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Status | Recruiting |
| Started | August 2026 |
| Main results expected | January 2027 |
| Study ends | June 2027 |
| Registry record updated | August 10, 2026 |
| Trial ID | NCT07646444 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years and older who had at least one OPN balloon used during a clinically indicated PCI in North America.
✕Probably not a fit
Patients whose care does not involve SIS-OPN balloon use or who are not part of the data collection may not see any direct benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The OPEN-SAFE registry is an observational effort to describe how the SIS-OPN non-compliant balloon is used during PCI for calcified coronary lesions and the outcomes observed in routine clinical practice. Data collection spans February 1, 2023 through December 31, 2028, at the Minneapolis Heart Institute Foundation. The study includes adults who had at least one OPN balloon during a clinically indicated PCI, with patients able to opt out of data collection. There is no randomization or experimental treatment; this registry aims to characterize real-world usage patterns and associated outcomes for patients with CAD, in-stent restenosis, or calcified lesions. The project is led by the Minneapolis Heart Institute Foundation and does not list additional collaborators or sites beyond the lead center.
Why it matters
Potential benefit: If successful, the registry could improve understanding of how the SIS-OPN balloon performs in routine care and inform future practice patterns.
How similar studies have gone: Prior experience with similar observational registries has provided useful real-world insights into device performance, though this exact SIS-OPN application is being evaluated in a dedicated registry.
Who can join: the full rules
Show full inclusion / exclusion 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 in research related data collection
Where it's running
-
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States Recruiting
Study contacts
- Study coordinator: Bavana V Rangan, BDS, MPH
- Email: Bavana.Rangan@allina.com
- Phone: 612-863-4768
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.