Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

Um Estudo Prospectivo, Multicêntrico, Randomizado e Controlado para Investigar o Valor da Angiografia por TC Coronária na Compreensão e Gestão do Cálcio Coronário (O Estudo Optimal)

9 de novembro de 2026 atualizado por: Fundación EPIC

Um Estudo Prospectivo, Multicêntrico, Randomizado e Controlado para Investigar o Valor da Angiografia por TC Coronária na Compreensão e Gestão do Cálcio Coronário

The OPTIMAL randomized clinical trial has been designed to compare two imaging strategies and to test the hypothesis that a calcium modification strategy informed by coronary CT angiography (CCTA) will improve procedural efficiency and effectiveness compared with the current standard of care (IVUS-guided PCI) while achieving similar clinical outcomes in patients with hemodynamically significant calcified coronary artery disease.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

The OPTIMAL Trial is a prospective, multicenter, randomized controlled study evaluating whether a coronary CT angiography (CCTA)-guided calcium modification strategy can improve the treatment of patients with hemodynamically significant, calcified coronary artery disease undergoing percutaneous coronary intervention (PCI).

Seven hundred patients with flow-limiting stenosis (FFRCT ≤0.80) and moderate-to-severe calcification on CCTA will be randomized 1:1 to either CCTA-guided or intravascular ultrasound (IVUS)-guided calcium modification. The study includes two co-primary endpoints: (1) superiority in final minimal stent area assessed by IVUS, and (2) non-inferiority in 12-month target vessel failure (cardiac death, target-vessel myocardial infarction, or ischemia-driven revascularization).

CCTA-guided strategy uses advanced calcium characterization to inform pre-procedural planning and selection of plaque modification techniques. IVUS-guided strategy follows contemporary intravascular imaging-based criteria for plaque preparation and PCI optimization.

The trial aims to determine whether leveraging non-invasive CT-based calcium assessment can enhance procedural efficiency and stent results while maintaining clinical safety comparable to IVUS-guided PCI.

Tipo de estudo

Intervencional

Inscrição (Estimado)

700

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: CAROLINA FOCELLA
  • Número de telefone: 001 917 753 6695
  • E-mail: cfocella@crf.org

Estude backup de contato

Locais de estudo

      • Aalst, Bélgica, 9300
        • Recrutamento
        • Azorg Hospital, Aalst
      • Barcelona, Espanha, 08035
        • Recrutamento
        • Hospital Universitari Vall Hebron
      • León, Espanha
        • Recrutamento
        • Hospital Universitario de Leon
      • Madrid, Espanha, 28046
        • Recrutamento
        • Hospital Universitario La Paz
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02115
        • Ainda não está recrutando
        • Bringham and Women's Hospital
    • Minnesota
      • Minneapolis, Minnesota, Estados Unidos, 55407
        • Recrutamento
        • Minneapolis Heart Institute
    • New Jersey
      • Jersey City, New Jersey, Estados Unidos, 08837
        • Ainda não está recrutando
        • HACKENSACK MERIDIAN HEALTH, Inc
    • New York
      • New York, New York, Estados Unidos, 14853
        • Ainda não está recrutando
        • Weill Medical College of Cornell University
      • New York, New York, Estados Unidos, 10032
        • Recrutamento
        • NewYork-Presbyterian/Weill Cornell Medical Center
      • Leicester, Reino Unido
        • Recrutamento
        • University Hospitals of Leicester NHS Trust
      • London, Reino Unido
        • Recrutamento
        • St Bartholomew's Hospital (Barts Health NHS Trust)
      • London, Reino Unido
        • Recrutamento
        • St George's University Hospitals NHS Foundations Trust
        • Contato:
          • James Spratt, MD, PhD
      • London, Reino Unido
        • Recrutamento
        • Guys & St Thomas Nhs Foundation Trust
      • Newcastle, Reino Unido
        • Ainda não está recrutando
        • Newcastle Hospitals NHS Foundations Trust
      • Oxford, Reino Unido
        • Ainda não está recrutando
        • John Radcliffe Hospital, Oxford

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 85 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • The subject must be at least 18 years of age and younger than 85 years old
  • Subject must have evidence of myocardial ischemia (e.g., stable angina, silent ischemia (ischemia in the absence of chest pain or other anginal equivalents), unstable angina, or acute myocardial infarction) suitable for PCI. Patients with a clinical indication for revascularization presenting with stable coronary artery disease or stabilized acute coronary syndrome defined as follows unstable angina (Braunwald class IB, IC, IIB, IIC, IIIB, IIIC), patients with NSTEMI without high-risk features such as recurrence of chest pain, ST-segment depression>1mm in ≥6 leads plus STsegment elevation in aVR, life-threatening arrhythmias, mechanical complications of MI, resuscitated cardiac arrest, GRACE risk score>140.
  • All target vessels must have reference vessel diameter (visually assessed by CCTA) ≥ 2.5 mm
  • Subject must provide written informed consent before any study-related procedure

Exclusion Criteria:

  • STEMI as the clinical presentation.
  • Uncontrolled or recurrent ventricular tachycardia.
  • Hemodynamic instability.
  • Hemodialysis or peritoneal dialysis.
  • Left main coronary artery stenosis > 50%
  • Atrial fibrillation, flutter, or arrhythmias during CT acquisition.
  • Previous PCI in the target vessel or CABG.
  • BMI ≥ 40 kg/m2
  • Insufficient CT quality assessed by the Core lab.
  • Comorbidity with life expectancy ≤ 2 years.
  • Planned major cardiac or non-cardiac surgery within 24 months after the index procedure Note: Major surgery is any invasive operative procedure in which an extensive resection is performed, e.g., a body cavity is entered, organs are removed, or normal anatomy is altered. Note: Minor surgery is an operation on the superficial structures of the body or a manipulative procedure that does not involve a serious risk. Planned minor surgery is not excluded.
  • The subject has received a solid organ transplant that is functioning or is active on a waiting list for any solid organ transplants with expected transplantation within 24 months.
  • The subject receives immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.). Note: corticosteroids are not included as immunosuppressant therapy.
  • The subject has previously received or is scheduled to receive radiotherapy to a coronary artery (vascular brachytherapy) or the chest/mediastinum.
  • Subject has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3.
  • The subject has a documented or suspected hepatic disorder as defined as cirrhosis or Child-Pugh ≥ Class B.
  • The subject has a history of bleeding diathesis or coagulopathy or has had a significant gastro-intestinal or significant urinary bleed within the past six months. The subject has had a cerebrovascular accident or transient ischemic neurological attack (TIA) within the past six months, or any prior intracranial bleed, or any permanent neurologic defect, or any known intracranial pathology (e.g., aneurysm, arteriovenous malformation, etc. The subject has a life expectancy <2 years for any non-cardiac cause.
  • Subject is currently participating in another investigational drug or device clinical study.
  • Pregnant or nursing subjects and those who plan pregnancy in the period up to 2 years following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.
  • Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
  • Unable to provide written informed consent (IC).

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: CT-guide calcium modification strategy

Pre-procedural CT will be used to determine lesion characteristics.

CT will be used to determine lesion characteristics and post-procedural IVUS to confirm correct implantation of stent

Comparador Ativo: IVUS-guide calcium modification strategy

Pre-procedural IVUS will be used to determine lesion characteristics.

IVUS will be used to determine lesion characteristics and post-procedural IVUS to confirm correct implantation of stent

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Demonstrate that CT-guided calcium modification results in a superior final MSA Minimal Stent Area (MSA) - Imaging Endpoint (Superiority)
Prazo: Perioperative/Periprocedural

Final post-PCI minimal stent area per target lesion, measured by independent core laboratory using intravascular ultrasound (IVUS). Assesses whether CT-guided calcium modification results in superior stent expansion compared with IVUS-guided PCI.

Perioperative/Periprocedural
Target Vessel Failure (TVF) - Clinical Endpoint (Non-Inferiority)
Prazo: 12 months

Composite of cardiac death, target-vessel myocardial infarction (TV-MI), or ischemia-driven target vessel revascularization (ID-TVR). TV-MI and ID-TVR are defined according to ARC-2 and the Fourth Universal Definition of MI.

12 months

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Procedural efficiency: Procedure time
Prazo: During PCI

Time from first angiogram to final angiogram

During PCI
Procedural efficiency:Radiation dose-area product
Prazo: During PCI

Dose-area product (DAP) recorded during PCI.

During PCI
Procedural efficiency: Contrast volume
Prazo: During PCI

Total contrast volume (mL) used during PCI.IVUS-Derived Mechanistic Endpoints (Core Lab)

During PCI
Procedural Efficiency: Stent Area on Immediate Post-Stent IVUS
Prazo: Perioperative/Periprocedural

MSA prior to any final IVUS-guided optimization.

Perioperative/Periprocedural
Procedural Efficiency: Final Stent Area at Original Minimal Lumen Area (MLA)
Prazo: Perioperative/Periprocedural

Stent area at the co-registered site of the baseline MLA.

Perioperative/Periprocedural
Procedural Efficiency: Final Stent Area at Site of Maximum Calcium Arc
Prazo: Perioperative/Periprocedural

Stent area measured at the co-registered IVUS site with maximal calcium arc

Perioperative/Periprocedural
Procedural Efficiency: Final Stent Area at Site of Maximum Calcium Density
Prazo: Perioperative/Periprocedural

Stent area measured at the co-registered CT-identified region of greatest Hounsfield Unit (HU) calcium density.

Perioperative/Periprocedural
Procedural Efficiency: Relative Stent Expansion
Prazo: Perioperative/Periprocedural

Percentage expansion calculated as:

MSA ÷ mean distal reference lumen area × 100.

Perioperative/Periprocedural
Procedural Efficiency: Number of Calcium Fractures
Prazo: Post-modification, pre-stent

Fractures identified on intermediary IVUS after calcium modification.

Post-modification, pre-stent
Procedural Efficiency: Change in Plaque Attenuation
Prazo: Post-modification, pre-stent

Change in IVUS plaque characteristics following calcium modification.Angiographic Endpoints

Post-modification, pre-stent
Procedural Efficiency: Final Minimal Lumen Diameter
Prazo: Perioperative/Periprocedural

Minimum lumen diameter by quantitative coronary angiography (QCA)

Perioperative/Periprocedural
Procedural Efficiency: Final Percent Diameter Stenosis
Prazo: Perioperative/Periprocedural

Percent stenosis of treated lesion after PCI, by QCA

Perioperative/Periprocedural
Procedural Efficiency: Final TIMI Flow Grade
Prazo: Perioperative/Periprocedural

Target vessel flow graded 0-3 based on TIMI criteria. Thrombolysis In Myocardial Infarction (TIMI) Flow Grade is a 0-3 angiographic scale used during coronary angiography to describe how well blood is flowing through a coronary artery.TIMI 0 No perfusion, TIMI 1 Penetration without perfusion, TIMI 2 Partial perfusion TIMI 3 Complete perfusion (normal flow)

Perioperative/Periprocedural
Procedural Efficiency: Angiographic Complications
Prazo: Day of procedure

According to Coronary dissection (NHLBI classification)

Day of procedure
Procedural Efficiency: Angiographic Complications
Prazo: Day of procedure

According to Coronary perforation (Ellis classification)

Day of procedure
Procedural Efficiency: Angiographic Complications
Prazo: Day of procedure

Slow-flow / no-reflow

Day of procedure
Procedural Efficiency: Angiographic Complications
Prazo: Day of procedure

Side branch closure (TIMI 0-1)

Day of procedure
Clinical & Safety Outcomes: Procedural Success
Prazo: Perioperative/Periprocedural

Final stenosis <30%, TIMI 3 flow, no angiographic complications, and no in-hospital major adverse cardiac events (MACE).

Perioperative/Periprocedural
Clinical & Safety Outcomes: Periprocedural Myocardial Infarction (Type 4a MI)
Prazo: Day 0-1

Defined by ARC-2 and 4th Universal Definition of MI (troponin criteria + evidence of ischemia).

Day 0-1
Clinical & Safety Outcomes: Stent Thrombosis
Prazo: Up to 12 months

Definite or probable stent thrombosis according to ARC-2 definitions.

Up to 12 months
Patient-Reported Outcomes: Residual Angina (SAQ-7 Angina Frequency)
Prazo: 12 months

Residual angina defined as SAQ-7 Angina Frequency score <100. Angina frequency represent how often a patient has had angina (chest pain/discomfort) over a recent recall period. Reported as a 0 to 100 scale: 100 = no angina; 0 = angina occurring very frequently

12 months
Patient-Reported Outcomes: Change in Angina (SAQ-7)
Prazo: Baseline to 12 months

Change in angina frequency domain score; positive values indicate improvement. Angina frequency represent how often a patient has had angina (chest pain/discomfort) over a recent recall period. Reported as a 0 to 100 scale: 100 = no angina; 0 = angina occurring very frequently

Baseline to 12 months

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Colaboradores

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

22 de dezembro de 2025

Conclusão Primária (Estimado)

15 de dezembro de 2029

Conclusão do estudo (Estimado)

1 de janeiro de 2030

Datas de inscrição no estudo

Enviado pela primeira vez

28 de novembro de 2025

Enviado pela primeira vez que atendeu aos critérios de CQ

12 de dezembro de 2025

Primeira postagem (Real)

16 de dezembro de 2025

Atualizações de registro de estudo

Última Atualização Postada (Real)

10 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

9 de novembro de 2026

Última verificação

1 de novembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Outros números de identificação do estudo

  • EPIC46-THE OPTIMAL TRIAL

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .