The Influence of Modifying Highly Calcified Coronary Lesions on Coronary Microcirculation

NCT ID: NCT06507449

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-07
• Study Completion Date: 2026-12-31

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).

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

High-pressure non-compliant balloon

Intervention Type: DEVICE

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

Optical coherence tomography

Intervention Type: DEVICE

Optical coherence tomography assessment of coronary arteries.

Coroventis Coroflow Cardiovascular System and PressureWire™ X Guidewire

Intervention Type: DEVICE

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

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.

Group Type: EXPERIMENTAL

Orbital atherectomy

Intervention Type: DEVICE

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

Optical coherence tomography

Intervention Type: DEVICE

Optical coherence tomography assessment of coronary arteries.

Coroventis Coroflow Cardiovascular System and PressureWire™ X Guidewire

Intervention Type: DEVICE

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

Lithotripsy

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

Group Type: EXPERIMENTAL

Lithotripsy

Intervention Type: DEVICE

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

Optical coherence tomography

Intervention Type: DEVICE

Optical coherence tomography assessment of coronary arteries.

Coroventis Coroflow Cardiovascular System and PressureWire™ X Guidewire

Intervention Type: DEVICE

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

Interventions

Lithotripsy

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

Intervention Type: DEVICE

Orbital atherectomy

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

Intervention Type: DEVICE

High-pressure non-compliant balloon

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

Intervention Type: DEVICE

Optical coherence tomography

Optical coherence tomography assessment of coronary arteries.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Polish Cardiac Society

OTHER

Sponsor Role: collaborator

Medical University of Silesia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paweł Gąsior, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Upper Silesian Medical Centre

Katowice, , Poland

Countries

Poland

Other Identifiers

BNW/NWN/0052/KB1/4/24

Identifier Type: -

Identifier Source: org_study_id