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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: PCI; Coronary Arterial Disease (CAD)
• Intervention / Treatment: Device: 7F Thin-Walled Sheath; Device: 6F Thin-Walled Sheath

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.

• Study Type: Interventional
• Enrollment (Estimated): 574
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100037
      • FuWai Hospital, CAMS & PUMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radial Artery Occlusion Rate 24 Hours Post-Procedure	The primary outcome is the rate of radial artery and distal radial artery occlusion 24 hours after the procedure. Occlusion will be determined by the absence of blood flow spectrum in the radial artery as assessed by ultrasound.	24 hours post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)	The incidence of major adverse cardiovascular and cerebrovascular events during the follow-up period, including all-cause mortality, cardiovascular mortality, new-onset myocardial infarction, and new-onset stroke.	Up to 30 days post-procedure
Cannulation Success Rate	The success rate of sheath insertion and placement in the radial artery during the coronary intervention procedure.	During the procedure
PCI Success Rate	The success rate of the percutaneous coronary intervention (PCI) procedure, defined by the successful completion of the intended intervention with appropriate device placement and without the need for conversion to an alternative access site.	During the procedure
Radial Artery Occlusion Rate 30 Days Post-Procedure	The rate of radial artery and distal radial artery occlusion 30 days after the procedure, assessed by ultrasound.	30 days post-procedure
Major Bleeding Events	The incidence of major bleeding events, defined according to the Bleeding Academic Research Consortium (BARC) criteria (Type 3 or Type 5 bleeding).	Up to 30 days post-procedure
Local Neurological Complications	The incidence of local neurological complications, including numbness, tingling, or motor deficits in the arm used for radial artery access.	Up to 30 days post-procedure
Incidence and Severity of Forearm Hematoma	Forearm hematoma will be graded using the EASY (Early Discharge After Transradial Stenting of Coronary Arteries Study) hematoma scale. The scale ranges from Grade I to Grade V: Grade I: Hematoma <5 cm in diameter (non-significant) Grade II: Hematoma 5-10 cm in diameter (mild) Grade III: Hematoma >10 cm but distal to the elbow (moderate) Grade IV: Hematoma extending above the elbow (severe) Grade V: Hematoma associated with ischemic threat to the hand (compartment syndrome) Higher grades indicate worse outcomes.	Up to 30 days post-procedure
Pain Scores	Patient-reported pain scores assessed using the Visual Analog Scale (VAS). The scale ranges from 0 (no pain) to 10 (worst pain), with higher scores indicating worse outcomes.	Up to 30 days post-procedure
Daily Living Ability Scores	Daily living abilities assessed using the Barthel Index, which ranges from 0 (complete dependence) to 100 (complete independence), with higher scores indicating better outcomes.	Up to 30 days post-procedure
Length of Hospital Stay	The total length of hospital stay, measured in days, starting from the date of admission for the coronary intervention procedure until the date of discharge, with a maximum assessment period of up to 30 days post-procedure.	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	The incidence of unplanned additional interventions required during the initial hospitalization, including but not limited to additional PCI, vascular repair, or treatment of complications. The events will be assessed from the time of the procedure until the patient is discharged, with a maximum assessment period of up to 30 days post-procedure.	From the time of procedure until discharge, assessed up to 30 days post-procedure

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases
• Investigators: Principal Investigator: Lijian Gao, PhD. MD., Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2024
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): January 30, 2026

Study Registration Dates

• First Submitted: September 2, 2024
• First Submitted That Met QC Criteria: September 3, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 23, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Radial Artery Occlusion; Coronary Intervention; Non-Inferiority Trial; Distal Radial Artery Access; 7F Sheath; 6F Sheath
• Other Study ID Numbers: 2024-2377

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The decision not to share individual participant data (IPD) is based on concerns related to patient confidentiality and data privacy. While all data collected in this study will be securely stored and managed, the nature of the data involves sensitive health information that could potentially identify participants. Furthermore, the current study does not have the necessary infrastructure or resources in place to manage the secure and controlled distribution of IPD to external researchers. Therefore, to protect participant privacy and adhere to ethical standards, we have decided not to share IPD for this trial.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No