NCT07646444 · Minneapolis Heart Institute Foundation
OPN Balloon for SAFE Recanalization of Calcified Coronary Lesions
(OPEN-SAFE)
What this study is about
The goal of the OPEN-SAFE registry is to describe the contemporary use and outcomes of SIS-OPN in North America.
View original scientific description
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
Descriptive summaries of incidence of in-hospital outcomes and MACE
Treatment Utilization
Time frame: intra-procedural
descriptive summaries of various treatments utilized before and after use of the OPN balloon
Predictors of Success and Failure for the OPN Balloon
Time frame: intra-procedural
Assess predictors for failure of the OPN balloon
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Minneapolis, Minnesota
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 10, 2026 · Source of record for eligibility and locations