A Multicenter Observational Registry to Evaluate Safety and Performance of Vivo ISAR (SECURE Global Registry)
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: Cardiovascular Diseases. 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
- Индия, Италия, Нидерланды, Великобритания
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
A Prospective, Open-Label, Multi-Country, Multicentre, Observational PoSt Market SurvEillance of VIVO ISAR (Polymer-Free Sirolimus Eluting Coronary Stent System) In Real World Patients Undergoing PCI With Short Dual Antiplatelet Therapy
Обзор
The objective of this post marketing observational registry is to evaluate clinical outcomes (safety and performance) in an all-comers population with coronary artery disease (CAD) treated with the Polymer Free Sirolimus Eluting Coronary Stent Vivo ISAR and planned for an abbreviated (≤ 3 months) dual antiplatelet therapy (DAPT) regimen.
Подробное описание
This study is a prospective, observational, multi-country, multi-Centre, single-arm registry designed to evaluate the clinical safety and performance of VIVO ISAR, Polymer Free Sirolimus Eluting Coronary Stent System. The study population is made up of subjects who have undergone PCI using VIVO ISAR and are receiving standard of care short DAPT treatment (≤ 3 months) . Subjects will be screened by site teams and offered the opportunity to participate in the registry after their procedure. Rationale for this study is to evaluate clinical outcomes and collect data of the Polymer Free Sirolimus Eluting Coronary Stent in real world CAD patients with follow-up at 1 month, 3 months and 12 months.
All medications and procedures to be used/ performed in this registry are commonly used/performed for clinical indications as part of standard of care and have well-defined safety profiles.
The study does not influence the choice of device utilized nor does it alter the routine standard of care. After a patient has been treated with the Vivo ISAR, informed consent will be requested and the eligible patient will be registered in the study.
Baseline data will be completed using medical notes. All recruited subjects will then be followed as per routine practice together with telephonic follow-up at 30 days, 3 months and 12 months from the baseline PCI procedure date.
The 30 day, 3 months and 12 month telephonic follow up will consist of a verbally report of the DAPT anticoagulation medications continued, about any lab assessments that might have happened, recording of any adverse events, and any interventional treatment that has occurred since previous contact.
Первичные конечные точки
- Ischemic endpoint [Срок оценки: 12 months]
- Bleeding endpoint [Срок оценки: 12 months]
Вторичные конечные точки (9)
- All-cause mortality [Срок оценки: 12 months]
- Cardiovascular death [Срок оценки: 12 months]
- Myocardial infarction (MI) [Срок оценки: 12 months]
- Stroke [Срок оценки: 12 months]
- Stent thrombosis (definite/probable) [Срок оценки: 12 months]
- Target Lesion Revascularisation (TLR) - Ischemia driven (ID) [Срок оценки: 12 months]
- Urgent TLR [Срок оценки: 12 months]
- Target vessel revascularisation (TVR) [Срок оценки: 12 months]
- BARC class 2 bleeding [Срок оценки: 12 months]
Критерии участия
Критерии включения
- Ability to provide written informed consent.
- Treated only with the VIVO ISAR stent system.
- ≥ 18 years old.
- Male or non-pregnant female patient.
- Intended for treatment with ≤ 3 months DAPT after PCI as per standard of care.
Критерии исключения
- Patients having any of the following conditions will not be considered (enrolled) for the study Concurrent participation in an interventional study.
- Cardiogenic shock/hemodynamic instability around the time of the index procedure.
- Concurrent medical condition with a life expectancy of less than 12 months.
- Allergy or contraindication to antiplatelet therapy, cobalt chromium, sirolimus or any known hypersensitivity to the planned anti-platelet drugs.
- History of cerebrovascular accident in the last 6 months.
- Pregnant female.
- PCI performed within the previous 3 months from the date of index procedure
- Treated with another stent type during the index procedure in addition to the VIVO ISAR stent system
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Другое
Центры проведения
Индия · 17 центров
- Zydus Hospitals — Ahmedabad
- Fortis Hospital — Bangalore
- Adesh Hospital — Bathinda
- PGIMER — Chandigarh
- National Heart Institute — Delhi
- Fortis Escorts Heart Institute & Research Centre — Delhi
- Fortis Escorts Heart Institute & Research Centre — Delhi
- Medanta-The Medicity — Gurugram
- … и ещё 9 центров
Италия · 7 центров
- ASREM - Regional Hospitals — Campobasso
- Montevergine — Mercogliano AV
- Clinica Mediterranea — Naples
- University of Padua, Padova — Padova
- Clinica Pierangeli — Pescara
- Santo Spirito Hospital — Pescara
- Tor Vergata University — Roma
Великобритания · 5 центров
- Bedford Hospital — Bedford
- Freeman Hospital — Newcastle
- Derriford Hospitalm Plymouth NHS Trust — Plymouth
- Salisbury NHS Foundation Trust — Salisbury
- Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust — Wigan
Нидерланды · 3 центра
- Amsterdam UMC (University Medical Centers) — Amsterdam
- Tergooi MC — Hilversum
- Viecuri MC — Venlo
Идентификаторы
NCT: NCT06412250 · TL/SECURE/VIVO/2023-01