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Indflydelsen af ​​at ændre stærkt forkalkede koronare læsioner på koronar mikrocirkulation

10. november 2026 opdateret af: Medical University of Silesia

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).

Studieoversigt

Status

Tilmelding efter invitation

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

30

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Polen
      • Katowice, Polen, 40-081
        • Upper Silesian Medical Centre

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Enhed: High-pressure non-compliant balloon

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

Enhed: Optical coherence tomography

Optical coherence tomography assessment of coronary arteries.

Enhed: 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.
Eksperimentel: 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.
Enhed: Optical coherence tomography

Optical coherence tomography assessment of coronary arteries.

Enhed: 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.

Enhed: Orbital atherectomy

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

The Shockwave® Medical system will be used for intravascular lithotripsy (IVL) vessel preparation prior to implantation of a drug-eluting stent.
Enhed: Optical coherence tomography

Optical coherence tomography assessment of coronary arteries.

Enhed: 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.

Enhed: Lithotripsy

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Coronary Flow Reserve (CFR)
Tidsramme: Intraprocedural

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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Stent expansion
Tidsramme: Intraprocedural

Stent expansion (%) evaluated by optical coherence tomography.
Intraprocedural
Acceptable stent expansion
Tidsramme: Intraprocedural

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

Optimal stent expansion (cut-off value defined as >90%) evaluated by optical coherence tomography.
Intraprocedural
Minimal lumen diameter (MLD) difference
Tidsramme: Intraprocedural

Determination of a difference between quantitative OCT measured minimal lumen diameter (MLD) at the beginning and at the end of the procedure.
Intraprocedural
Procedural Success
Tidsramme: 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).
Up to 3 years
Strategy Success
Tidsramme: Intraprocedural

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

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The proportion of subjects that experience Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Tidsramme: Up to 3 years

30-day and 1 year MACCE defined as a composite of cardiovascular death, myocardial infarction at the targeted vessel, targeted coronary vessel revascularization (PCI or CABG), TIA or stroke.
Up to 3 years
The proportion of subjects that experience Target Vessel Revascularization (TVR)
Tidsramme: Up to 3 years

30-day and 1 year Target Vessel Revascularization (TVR) - defined as any repeat revascularization at the target vessel (inclusive of the target lesion) and target vessel collaterals after the completion of the procedure.
Up to 3 years
The proportion of subjects that experience Target Lesion Revascularization (TLR)
Tidsramme: Up to 3 years

30-day and 1 year Target Lesion Revascularization (TLR) - defined as repeat intervention PCI or surgery within the index procedure stent or 5mm proximal or distal to the stent.
Up to 3 years
Myocardial infarction (MI) rate at 30-day and 1 year
Tidsramme: Up to 3 years

The proportion of subjects that experience a Myocardial Infarction (MI) at 30-day and 1 year.
Up to 3 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Medical University of Silesia

Samarbejdspartnere

Polish Cardiac Society

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

10. november 2026

Primær færdiggørelse (Anslået)

1. august 2027

Studieafslutning (Anslået)

1. december 2027

Datoer for studieregistrering

Først indsendt

12. juli 2024

Først indsendt, der opfyldte QC-kriterier

12. juli 2024

Først opslået (Faktiske)

18. juli 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • BNW/NWN/0052/KB1/4/24

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ja

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