The Influence of Modifying Highly Calcified Coronary Lesions on Coronary Microcirculation

NCT06507449 | Enrolling By Invitation FDA Device

• 1 other identifier: BNW/NWN/0052/KB1/4/24
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Coronary Artery Calcification; Ischemic Heart Disease; Non-ST-Segment Elevation Myocardial Infarction (NSTEMI); Coronary Artery Disease; Angina, Unstable; Tomography, Optical Coherence

Keywords

Percutaneous coronary intervention; Microcirculation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Stent expansion

  Intraprocedural

• Acceptable stent expansion

  Intraprocedural

• Optimal stent expansion

  Intraprocedural

• Minimal lumen diameter (MLD) difference

  Intraprocedural

• Procedural Success

  Up to 3 years

Other Outcomes (4)

• The proportion of subjects that experience Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)

  Up to 3 years

• The proportion of subjects that experience Target Vessel Revascularization (TVR)

  Up to 3 years

• The proportion of subjects that experience Target Lesion Revascularization (TLR)

  Up to 3 years

Study Arms (3)

High-pressure non-compliant balloon

EXPERIMENTAL

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; Device: Optical coherence tomography; Device: Coroventis Coroflow Cardiovascular System and PressureWire™ X Guidewire

Orbital atherectomy

EXPERIMENTAL

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: Orbital atherectomy; Device: Optical coherence tomography; Device: Coroventis Coroflow Cardiovascular System and PressureWire™ X Guidewire

Lithotripsy

EXPERIMENTAL

The Shockwave® Medical system will be used for intravascular lithotripsy (IVL) vessel preparation prior to implantation of a drug-eluting stent.

Device: Lithotripsy; Device: Optical coherence tomography; Device: Coroventis Coroflow Cardiovascular System and PressureWire™ X Guidewire

Interventions

Lithotripsy DEVICE

Calcified lesion preparation using lithotripsy before implantation of a drug-eluting stent

Lithotripsy

Orbital atherectomy DEVICE

Calcified lesion preparation using orbital atherectomy before implantation of a drug-eluting stent

Orbital atherectomy

High-pressure non-compliant balloon DEVICE

Calcified lesion preparation using high-pressure non-compliant balloon before implantation of a drug-eluting stent

High-pressure non-compliant balloon

Optical coherence tomography DEVICE

Optical coherence tomography assessment of coronary arteries.

High-pressure non-compliant balloon; Lithotripsy; Orbital atherectomy

Coroventis Coroflow Cardiovascular System and PressureWire™ X Guidewire DEVICE

A coronary thermodilution system used for evaluate differences between the impact of calcified lesion preparation methods on coronary microvascular function.

High-pressure non-compliant balloon; Lithotripsy; Orbital atherectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Silesia: lead
• Polish Cardiac Society: collaborator

Study Sites (1)

Upper Silesian Medical Centre

Katowice, 40-081, Poland

Location

MeSH Terms

Conditions

Myocardial Ischemia; Non-ST Elevated Myocardial Infarction; Coronary Artery Disease; Angina, Unstable

Interventions

Lithotripsy; Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Ultrasonic Surgical Procedures; Surgical Procedures, Operative; Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• Paweł Gąsior, MD, PhD

  Division of Cardiology and Structural Heart Diseases, Medical University of Silesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: July 18, 2024
• Study Start: March 7, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)