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

NCT ID: NCT06585917

Last Updated: 2025-02-25

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 574 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-10
• Study Completion Date: 2026-01-30

Brief Summary

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.

Conditions

PCI; Coronary Arterial Disease (CAD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

7F Sheath Intervention Group

Participants in this arm will undergo coronary intervention using a 7F thin-walled sheath via distal radial artery access. This group will be used to assess the efficacy and safety of the 7F sheath compared to the 6F sheath.

Group Type: EXPERIMENTAL

7F Thin-Walled Sheath

Intervention Type: DEVICE

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.

6F Sheath Control Group

Participants in this arm will undergo coronary intervention using a 6F thin-walled sheath via distal radial artery access. This group will serve as the control to compare the outcomes against those of the 7F sheath group.

Group Type: ACTIVE_COMPARATOR

6F Thin-Walled Sheath

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lijian Gao, PhD. MD.

Role: PRINCIPAL_INVESTIGATOR

Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences

Locations

Fuwai Hospital, CAMS & PUMC

Beijing, Beijing Municipality, China

Countries

China

References

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 Sep 13:S0828-282X(25)01057-8. doi: 10.1016/j.cjca.2025.09.002. Online ahead of print.

Reference Type: DERIVED

PMID: 40953816 (View on PubMed)

Other Identifiers

2024-2377

Identifier Type: -

Identifier Source: org_study_id