The Influence of Modifying Highly Calcified Coronary Lesions on Coronary Microcirculation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lithotripsy, Orbital atherectomy, High-pressure non-compliant balloon, Optical coherence tomography.
- Who it may be relevant to
- Registry conditions: Coronary Artery Calcification, Ischemic Heart Disease, Non-ST-Segment Elevation Myocardial Infarction (NSTEMI), Coronary Artery Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Primary outcome measures
- Coronary Flow Reserve (CFR) [Time frame: Intraprocedural]
- Index of Microcirculatory Resistance (IMR) [Time frame: Intraprocedural]
Secondary outcome measures (6)
- Stent expansion [Time frame: Intraprocedural]
- Acceptable stent expansion [Time frame: Intraprocedural]
- Optimal stent expansion [Time frame: Intraprocedural]
- Minimal lumen diameter (MLD) difference [Time frame: Intraprocedural]
- Procedural Success [Time frame: Up to 3 years]
- Strategy Success [Time frame: Intraprocedural]
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.
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Poland · 1 center
- Upper Silesian Medical Centre — Katowice
Identifiers
NCT: NCT06507449 · BNW/NWN/0052/KB1/4/24