NCT06507449

The Influence of Modifying Highly Calcified Coronary Lesions on Coronary Microcirculation

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Medical University of Silesia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-03-07
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2024-07-18
• Last updated: 2025-11-24

Locations

1 site across 1 country: Poland

Regulatory

• FDA-regulated device study