Status:
ENROLLING_BY_INVITATION
Comparison of 6F and 7F Sheaths for Coronary Intervention Via Distal Radial Artery Access
Lead Sponsor:
China National Center for Cardiovascular Diseases
Conditions:
PCI
Coronary Arterial Disease (CAD)
Eligibility:
All Genders
18-80 years
Phase:
NA
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 arter...
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-w...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 30 2026
Estimated Enrollment :
574 Patients enrolled
Trial Details
Trial ID
NCT06585917
Start Date
September 10 2024
End Date
January 30 2026
Last Update
February 25 2025
Active Locations (1)
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1
Fuwai Hospital, CAMS & PUMC
Beijing, Beijing Municipality, China, 100037