Clinical trial NCT06585917: Comparison of 6F and 7F Sheaths for Coronary Intervention Via Distal Radial Artery Access
Official title: A Multicenter Study Comparing the Efficacy and Safety of 6F and 7F Thin-Walled Sheaths Via Distal Radial Artery Access for Coronary Intervention
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: PCI
Coronary Arterial Disease (CAD)
Keywords: Distal Radial Artery Access
Coronary Intervention
7F Sheath
6F Sheath
Radial Artery Occlusion
Non-Inferiority Trial
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2024-09-19
Enrollment: 574
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Radial Artery Occlusion Rate 24 Hours Post-Procedure
timeFrame: 24 hours post-procedure
Secondary outcomes:
measure: Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
timeFrame: Up to 30 days post-procedure
measure: Cannulation Success Rate
timeFrame: During the procedure
measure: PCI Success Rate
timeFrame: During the procedure
measure: Radial Artery Occlusion Rate 30 Days Post-Procedure
timeFrame: 30 days post-procedure
measure: Major Bleeding Events
timeFrame: Up to 30 days post-procedure
measure: Local Neurological Complications
timeFrame: Up to 30 days post-procedure
measure: Incidence and Severity of Forearm Hematoma
timeFrame: Up to 30 days post-procedure
measure: Pain Scores
timeFrame: Up to 30 days post-procedure
measure: Daily Living Ability Scores
timeFrame: Up to 30 days post-procedure
measure: Length of Hospital Stay
timeFrame: From the time of admission for the procedure until the date of discharge, assessed up to 30 days post-procedure
measure: Unplanned Additional Interventions During Hospitalization
timeFrame: From the time of procedure until discharge, assessed up to 30 days post-procedure
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital, CAMS &amp;amp; PUMC
state: Beijing
Study officials:
affiliation: Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences
name: Lijian Gao, PhD. MD.
role: PRINCIPAL_INVESTIGATOR
References: