La influencia de la modificación de las lesiones coronarias altamente calcificadas en la microcirculación coronaria
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).
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Katowice, Polonia, 40-081
- Upper Silesian Medical Centre
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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. |
Calcified lesion preparation using high-pressure non-compliant balloon before implantation of a drug-eluting stent Optical coherence tomography assessment of coronary arteries. A coronary thermodilution system used for evaluate differences between the impact of calcified lesion preparation methods on coronary microvascular function. |
|
Experimental: 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. |
Optical coherence tomography assessment of coronary arteries. A coronary thermodilution system used for evaluate differences between the impact of calcified lesion preparation methods on coronary microvascular function. Calcified lesion preparation using orbital atherectomy before implantation of a drug-eluting stent |
|
Experimental: Lithotripsy
The Shockwave® Medical system will be used for intravascular lithotripsy (IVL) vessel preparation prior to implantation of a drug-eluting stent. |
Optical coherence tomography assessment of coronary arteries. A coronary thermodilution system used for evaluate differences between the impact of calcified lesion preparation methods on coronary microvascular function. Calcified lesion preparation using lithotripsy before implantation of a drug-eluting stent |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Coronary Flow Reserve (CFR)
Periodo de tiempo: 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)
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Stent expansion
Periodo de tiempo: Intraprocedural
|
Stent expansion (%) evaluated by optical coherence tomography. |
Intraprocedural
|
|
Acceptable stent expansion
Periodo de tiempo: Intraprocedural
|
Acceptable stent expansion (cut-off value defined as >80%) evaluated by optical coherence tomography. |
Intraprocedural
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Optimal stent expansion
Periodo de tiempo: Intraprocedural
|
Optimal stent expansion (cut-off value defined as >90%) evaluated by optical coherence tomography. |
Intraprocedural
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Minimal lumen diameter (MLD) difference
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Intraprocedural
|
Strategy success - defined as procedural success without crossover to alternative treatment. |
Intraprocedural
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The proportion of subjects that experience Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Periodo de tiempo: 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
|
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The proportion of subjects that experience Target Vessel Revascularization (TVR)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: Up to 3 years
|
The proportion of subjects that experience a Myocardial Infarction (MI) at 30-day and 1 year. |
Up to 3 years
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Paweł Gąsior, MD, PhD, Division of Cardiology and Structural Heart Diseases, Medical University of Silesia
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Dolor
- Manifestaciones neurológicas
- Enfermedades Vasculares
- Enfermedades cardiovasculares
- Procesos Patológicos
- Enfermedades cardíacas
- Infarto
- Necrosis
- Arteriosclerosis
- Enfermedades arteriales oclusivas
- Enfermedad coronaria
- Infarto de miocardio
- Isquemia
- Dolor de pecho
- Angina de pecho
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Infarto de miocardio sin elevación del segmento ST
- Enfermedad de la arteria coronaria
- Isquemia miocardica
- Angina Inestable
- Técnicas de investigación
- Terapéutica
- Técnicas y procedimientos de diagnóstico
- Diagnóstico
- Procedimientos quirúrgicos, operativo
- Tomografía
- Imágenes de diagnóstico
- Tomografía, óptica
- Imagen óptica
- Procedimientos quirúrgicos ultrasónicos
- Tomografía, coherencia óptica
- Litotripia
Otros números de identificación del estudio
- BNW/NWN/0052/KB1/4/24
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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