The Influence of Modifying Highly Calcified Coronary Lesions on Coronary Microcirculation

Not Applicable

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

• Registration Number: NCT06507449
• Lead Sponsor: Medical University of Silesia

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.

Study Timeline

• Status Verified: 2024-03
• Study Start: 2024-03-07
• Study First Submitted: 2024-07-12
• Study First Submitted QC: 2024-07-12
• Last Update Submitted: 2024-07-12
• Study First Posted: 2024-07-18
• Last Update Posted: 2024-07-18
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-pressure non-compliant balloon	Optical coherence tomography	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.
High-pressure non-compliant balloon	Coroventis Coroflow Cardiovascular System and PressureWire™ X Guidewire	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.
High-pressure non-compliant balloon	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.
Orbital atherectomy	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.
Orbital atherectomy	Optical coherence tomography	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.
Orbital atherectomy	Coroventis Coroflow Cardiovascular System and PressureWire™ X Guidewire	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.
Lithotripsy	Lithotripsy	The Shockwave® Medical system will be used for intravascular lithotripsy (IVL) vessel preparation prior to implantation of a drug-eluting stent.
Lithotripsy	Coroventis Coroflow Cardiovascular System and PressureWire™ X Guidewire	The Shockwave® Medical system will be used for intravascular lithotripsy (IVL) vessel preparation prior to implantation of a drug-eluting stent.
Lithotripsy	Optical coherence tomography	The Shockwave® Medical system will be used for intravascular lithotripsy (IVL) vessel preparation prior to implantation of a drug-eluting stent.

Primary Outcome Measures

Name	Time	Method
Coronary Flow Reserve (CFR)	Intraprocedural	Determination of a difference between Coronary Flow Reserve (CFR) at the beginning and at the end of the procedure using CoroFlow™ Cardiovascular System.
Index of Microcirculatory Resistance (IMR)	Intraprocedural	Determination of a difference between Index of Microcirculatory Resistance (IMR) at the beginning and at the end of the procedure using CoroFlow™ Cardiovascular System.

Secondary Outcome Measures

Name	Time	Method
Strategy Success	Intraprocedural	Strategy success - defined as procedural success without crossover to alternative treatment.
Stent expansion	Intraprocedural	Stent expansion (%) evaluated by optical coherence tomography.
Acceptable stent expansion	Intraprocedural	Acceptable stent expansion (cut-off value defined as \>80%) evaluated by optical coherence tomography.
Optimal stent expansion	Intraprocedural	Optimal stent expansion (cut-off value defined as \>90%) evaluated by optical coherence tomography.
Minimal lumen diameter (MLD) difference	Intraprocedural	Determination of a difference between quantitative OCT measured minimal lumen diameter (MLD) at the beginning and at the end of the procedure.
Procedural Success	Up to 3 years	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).

Trial Locations

Locations (1)

Upper Silesian Medical Centre; 🇵🇱 Katowice, Poland