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

National Center for Cardiovascular Diseases

Status: Invitation-only

Conditions: Coronary Arterial Disease (CAD); PCI

Treatments: Device: 6F Thin-Walled Sheath; Device: 7F Thin-Walled Sheath

Study type: Interventional

Funder types: Other

Identifiers

NCT06585917

2024-2377

Details and patient eligibility

About

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.

Full 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.

Enrollment: 574 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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574 participants in 2 patient groups

7F Sheath Intervention Group

Experimental group

Description:

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.

Treatment:

Device: 7F Thin-Walled Sheath

6F Sheath Control Group

Active Comparator group

Description:

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.

Treatment:

Device: 6F Thin-Walled Sheath