A influência da modificação de lesões coronárias altamente calcificadas na microcirculação coronária
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).
Visão geral do estudo
Status
Condições
Descrição detalhada
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 estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Katowice, Polônia, 40-081
- Upper Silesian Medical Centre
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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 |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Coronary Flow Reserve (CFR)
Prazo: 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)
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Stent expansion
Prazo: Intraprocedural
|
Stent expansion (%) evaluated by optical coherence tomography. |
Intraprocedural
|
|
Acceptable stent expansion
Prazo: Intraprocedural
|
Acceptable stent expansion (cut-off value defined as >80%) evaluated by optical coherence tomography. |
Intraprocedural
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Optimal stent expansion
Prazo: Intraprocedural
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Optimal stent expansion (cut-off value defined as >90%) evaluated by optical coherence tomography. |
Intraprocedural
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Minimal lumen diameter (MLD) difference
Prazo: 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
Prazo: 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
Prazo: Intraprocedural
|
Strategy success - defined as procedural success without crossover to alternative treatment. |
Intraprocedural
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
The proportion of subjects that experience Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Dor
- Manifestações Neurológicas
- Doenças Vasculares
- Doenças cardiovasculares
- Processos Patológicos
- Doenças cardíacas
- Infarte
- Necrose
- Arteriosclerose
- Doenças Arteriais Oclusivas
- Doença cardíaca
- Infarto do miocárdio
- Isquemia
- Dor no peito
- Angina Pectoris
- Condições Patológicas, Sinais e Sintomas
- Sinais e sintomas
- Infarto do Miocárdio Sem Elevação do ST
- Doença arterial coronária
- Isquemia do miocárdio
- Angina Instável
- Técnicas de investigação
- Terapêutica
- Técnicas e procedimentos de diagnóstico
- Diagnóstico
- Procedimentos cirúrgicos, operatórios
- Tomografia
- Diagnóstico imagens
- Tomografia, óptica
- Imagem óptica
- Procedimentos cirúrgicos ultrassônicos
- Tomografia, coerência óptica
- Litotripsy
Outros números de identificação do estudo
- BNW/NWN/0052/KB1/4/24
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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