S-FLEX Netherlands Registry: Prospective Evaluation of the Supraflex Family Sirolimus-eluting Coronary Stent System

Официальное название

Prospective Evaluation of the Supraflex Family Sirolimus-eluting Coronary Stent System in a 'Real-World' Patient Population

Обзор

The primary objective of this registry is to evaluate the safety and efficacy of the Supraflex Family sirolimus-eluting coronary stent system in a 'real-world' patient population requiring stent implantation.

Подробное описание

To overcome the potential drawback of the durable polymer a new generation of drug-eluting stent (DES) with a biodegradable polymer has been designed. The first-generation sirolimus-eluting or paclitaxel-eluting stents have a polymer release of antiproliferative drugs from a stainless steel stent platform. More recently, second generation DES have been developed not only to improve long-term DES safety but also to facilitate the procedure by using a cobalt-chromium (Co-Cr) stent platform. Co-Cr is stronger and more radiopaque than stainless steel, and thus allows strut thickness and total stent volume to be reduced while maintaining radial strength leading to a more flexible and deliverable stent platform.

The Sahajanand Medical Technologies Pvt. Ltd. (SMT) has developed sirolimus-eluting stent that contain a biodegradable polymer coating and a Co-Cr stent platform. The purpose of this registry is to evaluate the Supraflex Family sirolimus-eluting stent in a 'real-world' patient population, in order to determine the safety and efficacy of the stent in wider usage.

Вмешательства

• Устройство Supraflex Family Sirolimus-eluting Coronary Stent System
  Patient implanted with at least one Supraflex Family sirolimus-eluting stent as a part of planned clinical care

Первичные конечные точки

• Target Lesion Failure (TLF) [Срок оценки: 12 months]

Вторичные конечные точки (6)

• Target Vessel Failure (TVF) [Срок оценки: 12 months]
• Major Adverse Cardiac Events (MACE) [Срок оценки: 12 months]
• Stent Thrombosis [Срок оценки: 12 months]
• All Deaths [Срок оценки: 12 months]
• Any Myocardial Infarction (MI) [Срок оценки: 12 months]
• Any Repeat Revascularization [Срок оценки: 12 months]

Критерии участия

Критерии включения

• Age ≥ 18 years
• The patient, or legal representative, has been informed of the nature of the registry and has consented to participate and authorised the collection and release of his/her medical information by signing a Patient Informed Consent Form
• Treating physician has electively implanted at least one Supraflex Family stent as part of the patient's planned clinical care.
• The patient is willing and able to cooperate with study procedures and required follow up visits

Критерии исключения

• Women with known pregnancy or who are lactating
• High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
• Currently participating in another study that has not completed the primary endpoint or that clinically interferes with the current registry requirements
• Planned surgery within 6-month of PCI unless dual anti-platelet therapy is maintained throughout the peri-surgical period

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Нидерланды · 7 центров

• Amphia Ziekenhuis — Breda
• Catharina Ziekenhuis — Eindhoven
• Tergooi Ziekenhuis — Blaricum
• Medical Center Leeuwarden — Leeuwarden
• Albert Schweitzer Ziekenhuis — Dordrecht
• Maasstad Ziekenhuis — Rotterdam
• ZorgSaam Hospital — Terneuzen

Идентификаторы

NCT: NCT03443999 · SFLX/Netherlands/001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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