The Influence of Modifying Highly Calcified Coronary Lesions on Coronary Microcirculation

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

Interventions

DEVICE

Lithotripsy

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

DEVICE

Orbital atherectomy

Calcified lesion preparation using orbital atherectomy before 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.

Sponsors & Collaborators

• Polish Cardiac Society

  collaborator OTHER

• Medical University of Silesia

  lead OTHER

Principal Investigators

• Paweł Gąsior, MD, PhD · Division of Cardiology and Structural Heart Diseases, Medical University of Silesia

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-03-07

Primary Completion

2026-06-30

Completion

2026-12-31

FDA Device

Yes

Countries

• Poland

Study Locations