Coronary Arterial Disease (CAD)OPEN-SAFENCT07646444
OPN Balloon for SAFE Recanalization of Calcified Coronary Lesions
An observational study of Coronary Arterial Disease (CAD) and In Stent Restenosis, run by Minneapolis Heart Institute Foundation at 1 site in United States.
Trial summary
The goal of the OPEN-SAFE registry is to describe the contemporary use and outcomes of SIS-OPN in North America. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Arterial Disease (CAD), In Stent Restenosis, Calcified Coronary Lesions
- What is being tested?
- non compliant balloon
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2026to Jun 2027
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals over the age of 18 who have undergone clinically indicated PCI with the use of the OPN balloon
Who may be able to join
- 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
Who cannot join
- Subjects who have opted out of being included in research related data collection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
Bavana Rangan, BDS, MPH, 612-863-4768, bavana.rangan@allina.com
About this study
Official title: OPN Balloon for SAFE Recanalization of Calcified Coronary Lesions (OPEN-SAFE Registry)
The goal of the OPEN-SAFE registry is to describe the contemporary use and outcomes of SIS-OPN in North America.
- Being tested
- non compliant balloon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non compliant balloonDevice
This is a registry tracking the use and outcomes of the OPN NC balloon, a non-compliant balloon
What is being measured
The primary outcome is the main question the study is designed to answer.
In-Hospital Outcomes
Descriptive summaries of incidence of in-hospital outcomes and MACE
Measured: periprocedural
Treatment Utilization
descriptive summaries of various treatments utilized before and after use of the OPN balloon
Measured: intra-procedural
Predictors of Success and Failure for the OPN Balloon
Assess predictors for failure of the OPN balloon
Measured: intra-procedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study startAug 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Arterial Disease (CAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Minneapolis Heart Institute Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07646444
- Sponsor's protocol ID
- 2437403-1
- Acronym
- OPEN-SAFE
- Status last verified
- Jun 2026
- First submitted
- 28 May 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPN Balloon for SAFE Recanalization of Calcified Coronary Lesions (OPEN-SAFE Registry)
- ClinicalTrials.gov ID
- NCT07646444
- Acronym / sponsor ID
- OPEN-SAFE / 2437403-1
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Minneapolis Heart Institute FoundationUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the OPEN-SAFE registry is to describe the contemporary use and outcomes of SIS-OPN in North America.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Week
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals over the age of 18 who have undergone clinically indicated PCI with the use of the OPN balloon
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Subjects who have opted out of being included in research related data collection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non compliant balloonThis is a registry tracking the use and outcomes of the OPN NC balloon, a non-compliant balloon | Device | – |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Arterial Disease (CAD) and In Stent Restenosis, run by Minneapolis Heart Institute Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bavana V Rangan, BDS, MPH (612-863-4768, Bavana.Rangan@allina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-Hospital Outcomes (time frame: periprocedural). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.