Not yet recruiting NCT07646444
OPN Balloon for SAFE Recanalization of Calcified Coronary Lesions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: non compliant balloon.
- Who it may be relevant to
- Registry conditions: Coronary Arterial Disease (CAD), In Stent Restenosis, Calcified Coronary Lesions. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
OPN Balloon for SAFE Recanalization of Calcified Coronary Lesions (OPEN-SAFE Registry)
Overview
The goal of the OPEN-SAFE registry is to describe the contemporary use and outcomes of SIS-OPN in North America.
Interventions
- Device non compliant balloon
This is a registry tracking the use and outcomes of the OPN NC balloon, a non-compliant balloon
Primary outcome measures
- In-Hospital Outcomes [Time frame: periprocedural]
- Treatment Utilization [Time frame: intra-procedural]
- Predictors of Success and Failure for the OPN Balloon [Time frame: intra-procedural]
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 in research related data collection
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07646444 · 2437403-1