The Influence of Modifying Highly Calcified Coronary Lesions on Coronary Microcirculation

November 18, 2025 updated by: Medical University of Silesia
This is a prospective, single-center, three-arm study to evaluate the impact of severely calcified coronary lesions treatment on microvascular circulation. We will enroll 30 conveniently sampled subjects assigned to one of three therapeutical methods lithotripsy, super-high pressure balloon, and orbital atherectomy prior to implantation of drug-eluting stents (DES).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This prospective, non-randomized, single-center study includes subjects who meet all of the inclusion and none of the exclusion criteria and sign the ICF. 30 patients with severe coronary stenosis will be enrolled. The severity will be assessed by Optical Coherence Tomography (OCT) based on the degree of calcification in the coronary lesion as defined by this protocol. Subjects will be assigned to one of three arms (lithotripsy, super-high pressure balloon or orbital atherectomy) followed by an implantation of drug-eluting stents (DES). The aposition and expansion of DES will be evaluated using OCT . Patients will be followed through discharge, 30 days and 12 months.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Katowice, Poland, 40-081
        • Upper Silesian Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subjects with native coronary artery disease (including stable or unstable angina and NSTEMI) suitable for PCI.
  • The lesion must be crossable with the study guide wire.
  • The target vessel reference diameter must be ≥ 2.5mm and ≤ 4.0 mm.
  • The target lesion must have evidence of severe calcium deposit at the lesion site based on the protocol criterion.
  • Subject or legally authorized representative, signs a written Informed Consent form to participate in the study, prior to any study-mandated procedures.
  • Male or female, age above or equal to 18 years at the time of signing informed consent.

Further inclusion criteria may apply

Exclusion Criteria:

  • Inability to understand the study or a history of non-compliance with medical advice.
  • Unwilling or unable to sign the Informed Consent Form (ICF).
  • History of any cognitive or mental health status that would interfere with trial participation.
  • Male or female, age under 18 years at the time of signing informed consent.
  • Female subjects who are pregnant or planning to become pregnant within the study period.
  • Subject has a known sensitivity to contrast media, which cannot be adequately pre-medicated.
  • Subject has evidence of an active infection on the day of the procedure requiring oral or intravenous antibiotics.
  • Limited long term prognosis due to other conditions.
  • Subjects in cardiogenic shock or with decompensated heart failure (NYHA class IV).
  • Subject diagnosed with chronic kidney disease stage 4 or greater (eGFR <30).
  • Most recent left ventricular ejection fraction ≤ 20%.
  • Subject is an acceptable candidate for coronary artery bypass surgery.
  • The target vessel reference diameter is under 2.0 mm.
  • Target lesion is located in or supplied by an arterial or venous bypass graft.
  • The target vessel has angiographically visible or suspected thrombus.
  • The target lesion is in an in-stent restenosis.
  • Subject has received a heart transplant.
  • Subject has major valve disease and underwent intervention within 30 days prior to randomization.

Further exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: High-pressure non-compliant balloon
The SIS Medical OPN NC® super high-pressure coronary balloon will be used for balloon angioplasty vessel preparation prior to implantation of a drug-eluting stent.
Device: High-pressure non-compliant balloon
Calcified lesion preparation using high-pressure non-compliant balloon before implantation of a drug-eluting stent
Device: Optical coherence tomography
Optical coherence tomography assessment of coronary arteries.
Device: Coroventis Coroflow Cardiovascular System and PressureWire™ X Guidewire
A coronary thermodilution system used for evaluate differences between the impact of calcified lesion preparation methods on coronary microvascular function.
Experimental: Orbital atherectomy
The Diamondback 360® Coronary Orbital Atherectomy System (OAS) will be used for orbital atherectomy (OA) vessel preparation prior to implantation of a drug-eluting stent.
Device: Optical coherence tomography
Optical coherence tomography assessment of coronary arteries.
Device: Coroventis Coroflow Cardiovascular System and PressureWire™ X Guidewire
A coronary thermodilution system used for evaluate differences between the impact of calcified lesion preparation methods on coronary microvascular function.
Device: Orbital atherectomy
Calcified lesion preparation using orbital atherectomy before implantation of a drug-eluting stent
Experimental: Lithotripsy
The Shockwave® Medical system will be used for intravascular lithotripsy (IVL) vessel preparation prior to implantation of a drug-eluting stent.
Device: Optical coherence tomography
Optical coherence tomography assessment of coronary arteries.
Device: Coroventis Coroflow Cardiovascular System and PressureWire™ X Guidewire
A coronary thermodilution system used for evaluate differences between the impact of calcified lesion preparation methods on coronary microvascular function.
Device: Lithotripsy
Calcified lesion preparation using lithotripsy before implantation of a drug-eluting stent

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Coronary Flow Reserve (CFR)
Time Frame: Intraprocedural
Determination of a difference between Coronary Flow Reserve (CFR) at the beginning and at the end of the procedure using CoroFlow™ Cardiovascular System.
Intraprocedural
Index of Microcirculatory Resistance (IMR)
Time Frame: Intraprocedural
Determination of a difference between Index of Microcirculatory Resistance (IMR) at the beginning and at the end of the procedure using CoroFlow™ Cardiovascular System.
Intraprocedural

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Stent expansion
Time Frame: Intraprocedural
Stent expansion (%) evaluated by optical coherence tomography.
Intraprocedural
Acceptable stent expansion
Time Frame: Intraprocedural
Acceptable stent expansion (cut-off value defined as >80%) evaluated by optical coherence tomography.
Intraprocedural
Optimal stent expansion
Time Frame: Intraprocedural
Optimal stent expansion (cut-off value defined as >90%) evaluated by optical coherence tomography.
Intraprocedural
Minimal lumen diameter (MLD) difference
Time Frame: Intraprocedural
Determination of a difference between quantitative OCT measured minimal lumen diameter (MLD) at the beginning and at the end of the procedure.
Intraprocedural
Procedural Success
Time Frame: Up to 3 years
Procedural success - defined as successful stent delivery and angiographic in-vessel residual stenosis <30%, and with the absence of any of the following: stent loss, coronary artery dissection, coronary artery perforation, PCI no reflow phenomenon or MACCE (defined as a composite of cardiovascular death, myocardial infarction at the targeted vessel, targeted coronary vessel revascularization (PCI or CABG), TIA or stroke).
Up to 3 years
Strategy Success
Time Frame: Intraprocedural
Strategy success - defined as procedural success without crossover to alternative treatment.
Intraprocedural

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The proportion of subjects that experience Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Time Frame: Up to 3 years
30-day and 1 year MACCE defined as a composite of cardiovascular death, myocardial infarction at the targeted vessel, targeted coronary vessel revascularization (PCI or CABG), TIA or stroke.
Up to 3 years
The proportion of subjects that experience Target Vessel Revascularization (TVR)
Time Frame: Up to 3 years
30-day and 1 year Target Vessel Revascularization (TVR) - defined as any repeat revascularization at the target vessel (inclusive of the target lesion) and target vessel collaterals after the completion of the procedure.
Up to 3 years
The proportion of subjects that experience Target Lesion Revascularization (TLR)
Time Frame: Up to 3 years
30-day and 1 year Target Lesion Revascularization (TLR) - defined as repeat intervention PCI or surgery within the index procedure stent or 5mm proximal or distal to the stent.
Up to 3 years
Myocardial infarction (MI) rate at 30-day and 1 year
Time Frame: Up to 3 years
The proportion of subjects that experience a Myocardial Infarction (MI) at 30-day and 1 year.
Up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of Silesia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Polish Cardiac Society

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Paweł Gąsior, MD, PhD, Division of Cardiology and Structural Heart Diseases, Medical University of Silesia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 7, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 18, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BNW/NWN/0052/KB1/4/24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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