The Influence of Modifying Highly Calcified Coronary Lesions on Coronary Microcirculation

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: Enrolling by invitation
• Conditions: Coronary Artery Disease; Ischemic Heart Disease; Angina, Unstable; Coronary Artery Calcification; Tomography, Optical Coherence; Non-ST-Segment Elevation Myocardial Infarction (NSTEMI)
• Intervention / Treatment: Device: High-pressure non-compliant balloon; Device: Optical coherence tomography; Device: Coroventis Coroflow Cardiovascular System and PressureWire™ X Guidewire; Device: Orbital atherectomy; Device: Lithotripsy

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: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Coronary Flow Reserve (CFR)	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)	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

Outcome Measure	Measure Description	Time Frame
Stent expansion	Stent expansion (%) evaluated by optical coherence tomography.	Intraprocedural
Acceptable stent expansion	Acceptable stent expansion (cut-off value defined as >80%) evaluated by optical coherence tomography.	Intraprocedural
Optimal stent expansion	Optimal stent expansion (cut-off value defined as >90%) evaluated by optical coherence tomography.	Intraprocedural
Minimal lumen diameter (MLD) difference	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	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	Strategy success - defined as procedural success without crossover to alternative treatment.	Intraprocedural

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of subjects that experience Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)	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)	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)	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	The proportion of subjects that experience a Myocardial Infarction (MI) at 30-day and 1 year.	Up to 3 years

Collaborators and Investigators

• Sponsor: Medical University of Silesia
• Collaborators: Polish Cardiac Society
• Investigators: Principal Investigator: Paweł Gąsior, MD, PhD, Division of Cardiology and Structural Heart Diseases, Medical University of Silesia

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: July 12, 2024
• First Submitted That Met QC Criteria: July 12, 2024
• First Posted (Actual): July 18, 2024

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Percutaneous coronary intervention; Microcirculation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Infarction; Ischemia; Chest Pain; Angina Pectoris; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Non-ST Elevated Myocardial Infarction; Coronary Artery Disease; Myocardial Ischemia; Angina, Unstable; Investigative Techniques; Therapeutics; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Tomography; Diagnostic Imaging; Tomography, Optical; Optical Imaging; Ultrasonic Surgical Procedures; Tomography, Optical Coherence; Lithotripsy
• Other Study ID 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