Comparison of 6F and 7F Sheaths for Coronary Intervention Via Distal Radial Artery Access

Официальное название

A Multicenter Study Comparing the Efficacy and Safety of 6F and 7F Thin-Walled Sheaths Via Distal Radial Artery Access for Coronary Intervention

Обзор

This is a multicenter, randomized controlled, prospective, non-inferiority, open-label study aiming to evaluate whether the efficacy and safety of using a 7F thin-walled sheath via distal radial artery (dTRA) access for coronary intervention (PCI) are non-inferior to the use of a 6F thin-walled sheath. The study population includes adult patients who are candidates for coronary intervention. The primary endpoint is the rate of radial artery and distal radial artery occlusion 24 hours post-procedure.

Подробное описание

This study is a multicenter, randomized controlled, prospective, non-inferiority, open-label clinical trial designed to compare the efficacy and safety of using 7F thin-walled sheaths versus 6F thin-walled sheaths for coronary intervention (PCI) via distal radial artery access (dTRA). The study will enroll adult patients with coronary artery disease who are scheduled to undergo PCI.

Participants will be randomized into two groups: the experimental group, which will receive PCI using a 7F sheath, and the control group, which will receive PCI using a 6F sheath. The primary endpoint is the rate of radial artery and distal radial artery occlusion 24 hours post-procedure, assessed by ultrasound. Secondary endpoints include the incidence of major adverse cardiovascular and cerebrovascular events during follow-up, cannulation success rate, PCI success rate, and the rate of radial artery occlusion at 30 days post-procedure, among others.

The study aims to determine whether the 7F sheath is non-inferior to the 6F sheath in terms of safety and efficacy for PCI through dTRA. The study will be conducted at multiple centers in China, with a planned enrollment of 574 participants, and it will span from Sep 2024 to January 2026. All procedures will adhere to the highest standards of clinical practice, and patient data will be managed with strict confidentiality.

Вмешательства

• Устройство 7F Thin-Walled Sheath
  The 7F Thin-Walled Sheath is used during coronary intervention procedures via distal radial artery access. This device has a smaller outer diameter compared to traditional 7F sheaths, designed to reduce the risk of vascular complications while allowing for the performance of complex coronary interventions.
• Устройство 6F Thin-Walled Sheath
  The 6F Thin-Walled Sheath is the standard device used in coronary intervention procedures via distal radial artery access. It is employed as a control in this study to compare its efficacy and safety against the 7F Thin-Walled Sheath.

Первичные конечные точки

• Radial Artery Occlusion Rate 24 Hours Post-Procedure [Срок оценки: 24 hours post-procedure]

Вторичные конечные точки (11)

• Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) [Срок оценки: Up to 30 days post-procedure]
• Cannulation Success Rate [Срок оценки: During the procedure]
• PCI Success Rate [Срок оценки: During the procedure]
• Radial Artery Occlusion Rate 30 Days Post-Procedure [Срок оценки: 30 days post-procedure]
• Major Bleeding Events [Срок оценки: Up to 30 days post-procedure]
• Local Neurological Complications [Срок оценки: Up to 30 days post-procedure]
• Incidence and Severity of Forearm Hematoma [Срок оценки: Up to 30 days post-procedure]
• Pain Scores [Срок оценки: Up to 30 days post-procedure]
• Daily Living Ability Scores [Срок оценки: Up to 30 days post-procedure]
• Length of Hospital Stay [Срок оценки: From the time of admission for the procedure until the date of discharge, assessed up to 30 days post-procedure]
• Unplanned Additional Interventions During Hospitalization [Срок оценки: From the time of procedure until discharge, assessed up to 30 days post-procedure]

Критерии участия

Критерии включения

• Age ≥18 years and ≤80 years;
• Height ≤180 cm;
• Distal radial artery diameter ≥1.7 mm;
• Completed distal radial artery angiography and requires coronary intervention;
• Tolerates dual antiplatelet therapy and intraoperative anticoagulant therapy, with no history of related drug allergies;
• Patient consents to participate in the study.

Критерии исключения

• Acute myocardial infarction requiring emergency PCI;
• Ultrasound-confirmed occlusion of the radial artery on the procedure side;
• Radial artery and distal radial artery anomalies (e.g., small caliber, tortuous, looped vessels) that make the dTRA approach unsuitable;
• Previous bilateral radial artery intervention or surgery;
• No coronary intervention performed after coronary angiography;
• Inability to undergo coronary angiography and intervention due to subjective or objective reasons;
• Coronary lesions requiring the use of a 7F guiding catheter;
• Coronary arteries not suitable for 7F guiding catheter;
• Severe liver or renal insufficiency, unresolved bleeding disorders, or other serious conditions with an expected survival of less than 1 year;
• Currently breastfeeding or known pregnancy.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Fuwai Hospital, CAMS & PUMC — Пекин

Публикации

• Liu M, Du Y, Cui C, Li C, Yu W, Wang H, Song Y, Gao Z, Song L, Zhai J, Yang Y, Yang W, Wu Y, Liu D, Guo J, Heisha N, Liu H, Zhao Y, Zhang F, Tang Y, Zhao Y, Yu M, Zhang B, Yang J, Li R, Li H, Xiong X, Guo X, Li H, Song Y, Duan F, Gao L. Distal Radial Artery Access With 6F and 7F Thin-Walled Sheaths for Coronary Intervention: A Multicentre, Randomized, DRAWS Trial Protocol. Can J Cardiol. 2025 Dec; PMID 40953816

Идентификаторы

NCT: NCT06585917 · 2024-2377

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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