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Идёт набор NCT07330622

Polish Registry of Percutaneous Coronary Intervention for Chronic Total Occlusions

Наблюдательное Coronary Occlusion Percutaneous Coronary Intervention

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Coronary Occlusion, Percutaneous Coronary Intervention. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Польша
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Polish Registry of Percutaneous Coronary Intervention for Chronic Total Occlusions (POL-CTO Registry)

Обзор

The goal of this observational study is to evaluate the safety, efficacy, and clinical outcomes of percutaneous coronary intervention (PCI) for chronic total occlusions (CTO) in patients treated in contemporary clinical practice in Poland. The main questions it aims to answer are: * What are the rates of procedural success and periprocedural complications of CTO PCI in routine clinical practice? * How do CTO PCI strategies and techniques, intravascular imaging, different treatment strategies, and mechanical circulatory support affect clinical outcomes? * How do clinical outcomes differ among different patient subgroups? * Can artificial intelligence-based analysis predict clinical and quality-of-life outcomes after CTO PCI? Patients undergoing CTO PCI as part of their standard medical care will be prospectively enrolled in a national, multicenter registry, with clinical, procedural, and follow-up data collected to evaluate real-world outcomes.

Подробное описание

Coronary chronic total occlusions (CTO) are diagnosed in approximately 20% of patients undergoing invasive coronary angiography, and their presence is associated with significantly reduced quality of life and worse long-term prognosis compared with patients without a CTO. Successful CTO recanalization improves quality of life, regional and global left ventricular function, and reduces myocardial ischemia in most patients. Over the past decade, the success rate of percutaneous coronary intervention (PCI) for CTO has increased substantially, largely due to advances in dedicated equipment and specialized procedural techniques. Concurrently, there is a growing need to evaluate the safety and effectiveness of contemporary CTO PCI techniques in selected patient populations.

The aim of the POL-CTO registry is to expand current knowledge regarding the safety and efficacy of CTO PCI in the contemporary Polish population across a broad range of clinical scenarios. Specifically, the registry will examine the incidence and management of periprocedural complications, as well as the impact of post-procedural cardiac injury markers on clinical outcomes. Comparative analyses of PCI performed with versus without intravascular imaging, along with different treatment strategies (drug-coated balloon \[DCB\], drug-eluting stent \[DES\], or hybrid approaches), will be conducted. Additional objectives include evaluating the safety of PCI with mechanical circulatory support and predicting quality-of-life improvement using artificial intelligence-based analysis of baseline electrocardiograms. Finally, the study will focus on CTO PCI outcomes in high-risk subgroups, including patients with low ejection fraction, frailty syndrome, severe coronary calcification, diabetes, prior transcatheter aortic valve implantation, prior coronary artery bypass grafting, and in-stent CTO.

Первичные конечные точки

  • Technical success [Срок оценки: procedural (1 day)]
Вторичные конечные точки (10)
  • Total procedure time [Срок оценки: procedural (1 day)]
  • Fluoroscopy time [Срок оценки: procedural (1 day)]
  • Radiation dose [Срок оценки: procedural (1 day)]
  • Contrast volume [Срок оценки: procedural (1 day)]
  • Number and type of procedural complications [Срок оценки: procedural (1 day)]
  • Successful guidewire crossing through CTO [Срок оценки: procedural (1 day)]
  • Time of successful guidewire crossing [Срок оценки: procedural (1 day)]
  • Target lesion failure [Срок оценки: in-hospital (2-5 days)]
  • Target lesion failure [Срок оценки: 1 year]
  • Death [Срок оценки: 1 year]

Критерии участия

Критерии включения

  • Patients undergoing CTO PCI based on clinical grounds

Критерии исключения

  • Age <18 years
  • Patient's refusal to participate in the registry

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Польша · 21 центр
  • Medical University of Białystok — Bialystok
  • Szpital Zachodni — Grodzisk Mazowiecki
  • Specialist Hospital in Inowrocław — Inowrocław
  • Medical University of Silesia — Katowice
  • Institute of Cardiology — Krakow
  • St. John Paul II Hospital — Krakow
  • Copper Health Centre Inc. — Lubin
  • 1st Military Clinical Hospital — Lublin
  • … и ещё 13 центров

Идентификаторы

NCT: NCT07330622 · 4.49/III/24

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗