Coronary Arterial Disease (CAD), PCI
Conditions
Keywords
Distal Radial Artery Access, Coronary Intervention, 7F Sheath, 6F Sheath, Radial Artery Occlusion, Non-Inferiority Trial
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.
Interventions
DEVICE7F 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.
DEVICE6F 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.
Sponsors
China National Center for Cardiovascular Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study uses a Parallel Assignment model, where participants are randomly assigned to one of two groups: the 7F sheath intervention group or the 6F sheath control group. Each group will receive a different size sheath for coronary intervention via distal radial artery access. The study is designed to compare the outcomes between these two groups, with no crossover between groups during the trial. This model allows for a direct comparison of the efficacy and safety between the two sheath sizes under similar clinical conditions.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
China
Outcome results
None listed