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Coronary Artery CalcificationNCT06507449

The Influence of Modifying Highly Calcified Coronary Lesions on Coronary Microcirculation

A study testing Lithotripsy, Orbital atherectomy and High-pressure non-compliant balloon in people with Coronary Artery Calcification and Ischemic Heart Disease, run by Medical University of Silesia at 1 site in Poland.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Lithotripsy, Orbital atherectomy and High-pressure non-compliant balloon
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 sitePoland
Study dates
7 Mar 2024to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 19Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Poland1 site

  • Upper Silesian Medical Centre

    Katowice, 40-081

Other trials in Poland

About this study

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).

Read the 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.

Being tested
Lithotripsy, Orbital atherectomy, High-pressure non-compliant balloon, Optical coherence tomography, Coroventis Coroflow Cardiovascular System and PressureWire™ X Guidewire
Keywords
Percutaneous coronary intervention, Microcirculation
Medical subject headings
Myocardial Ischemia, Non-ST Elevated Myocardial Infarction, Coronary Artery Disease, Angina, Unstable

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LithotripsyDevice

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

  • Orbital atherectomyDevice

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

  • High-pressure non-compliant balloonDevice

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

  • Optical coherence tomographyDevice

    Optical coherence tomography assessment of coronary arteries.

  • Coroventis Coroflow Cardiovascular System and PressureWire™ X GuidewireDevice

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

Study groups in NCT06507449
Study groupRoleWhat they receive
High-pressure non-compliant balloonExperimentalThe 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.
Receives: Device: High-pressure non-compliant balloon; Device: Optical coherence tomography; Device: Coroventis Coroflow Cardiovascular System and PressureWire™ X Guidewire
Orbital atherectomyExperimentalThe Diamondback 360® Coronary Orbital Atherectomy System (OAS) will be used for orbital atherectomy (OA) vessel preparation prior to implantation of a drug-eluting stent.
Receives: Device: Orbital atherectomy; Device: Optical coherence tomography; Device: Coroventis Coroflow Cardiovascular System and PressureWire™ X Guidewire
LithotripsyExperimentalThe Shockwave® Medical system will be used for intravascular lithotripsy (IVL) vessel preparation prior to implantation of a drug-eluting stent.
Receives: Device: Lithotripsy; Device: Optical coherence tomography; Device: Coroventis Coroflow Cardiovascular System and PressureWire™ X Guidewire

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Coronary Flow Reserve (CFR)

    Determination of a difference between Coronary Flow Reserve (CFR) at the beginning and at the end of the procedure using CoroFlow™ Cardiovascular System.

    Measured: Intraprocedural

  2. Index of Microcirculatory Resistance (IMR)

    Determination of a difference between Index of Microcirculatory Resistance (IMR) at the beginning and at the end of the procedure using CoroFlow™ Cardiovascular System.

    Measured: Intraprocedural

Secondary outcomes (6)

  1. Stent expansion

    Stent expansion (%) evaluated by optical coherence tomography.

    Measured: Intraprocedural

  2. Acceptable stent expansion

    Acceptable stent expansion (cut-off value defined as >80%) evaluated by optical coherence tomography.

    Measured: Intraprocedural

  3. Optimal stent expansion

    Optimal stent expansion (cut-off value defined as >90%) evaluated by optical coherence tomography.

    Measured: Intraprocedural

  4. Minimal lumen diameter (MLD) difference

    Determination of a difference between quantitative OCT measured minimal lumen diameter (MLD) at the beginning and at the end of the procedure.

    Measured: Intraprocedural

  5. Procedural Success

    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).

    Measured: Up to 3 years

  6. Strategy Success

    Strategy success - defined as procedural success without crossover to alternative treatment.

    Measured: Intraprocedural

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2024
  2. Study start7 Mar 2024
  3. Primary completionJun 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06507449
Sponsor's protocol ID
BNW/NWN/0052/KB1/4/24
Status last verified
Aug 2025
First submitted
12 Jul 2024
Last updated
24 Nov 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Lithotripsy, Orbital atherectomy and High-pressure non-compliant balloon in people with Coronary Artery Calcification and Ischemic Heart Disease, run by Medical University of Silesia at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Coronary Flow Reserve (CFR) (time frame: Intraprocedural). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06507449.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.

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