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

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Device 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.
• Device 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.

Primary outcome measures

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

Secondary outcome measures (11)

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

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Fuwai Hospital, CAMS & PUMC — Beijing

Publications

• 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

Identifiers

NCT: NCT06585917 · 2024-2377

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗