Comparison of 6F and 7F Sheaths for Coronary Intervention Via Distal Radial Artery Access
- Conditions
- PCICoronary Arterial Disease (CAD)
- Interventions
- Device: 7F Thin-Walled SheathDevice: 6F Thin-Walled Sheath
- Registration Number
- NCT06585917
- Lead Sponsor
- China National Center for Cardiovascular Diseases
- 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 574
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 7F Sheath Intervention Group 7F Thin-Walled Sheath 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. 6F Sheath Control Group 6F Thin-Walled Sheath 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.
- Primary Outcome Measures
Name Time Method Radial Artery Occlusion Rate 24 Hours Post-Procedure 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.
- Secondary Outcome Measures
Name Time Method Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) Up to 30 days post-procedure 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.
Cannulation Success Rate During the procedure The success rate of sheath insertion and placement in the radial artery during the coronary intervention procedure.
PCI Success Rate During the procedure 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.
Radial Artery Occlusion Rate 30 Days Post-Procedure 30 days post-procedure The rate of radial artery and distal radial artery occlusion 30 days after the procedure, assessed by ultrasound.
Major Bleeding Events Up to 30 days post-procedure The incidence of major bleeding events, defined according to the Bleeding Academic Research Consortium (BARC) criteria (Type 3 or Type 5 bleeding).
Local Neurological Complications Up to 30 days post-procedure The incidence of local neurological complications, including numbness, tingling, or motor deficits in the arm used for radial artery access.
Incidence and Severity of Forearm Hematoma Up to 30 days post-procedure 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.Pain Scores Up to 30 days post-procedure 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.
Daily Living Ability Scores Up to 30 days post-procedure Daily living abilities assessed using the Barthel Index, which ranges from 0 (complete dependence) to 100 (complete independence), with higher scores indicating better outcomes.
Length of Hospital Stay From the time of admission for the procedure until the date of discharge, assessed up to 30 days post-procedure 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.
Unplanned Additional Interventions During Hospitalization From the time of procedure until discharge, assessed up to 30 days post-procedure 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.
Trial Locations
- Locations (1)
Fuwai Hospital, CAMS &amp; PUMC
🇨🇳Beijing, Beijing, China