NCT Number: NCT07410364
Randomized controlled trial of adaptive design for the safety and efficacy of coronary angiography and percutaneous coronary intervention via distal transradial access using a 6-French Glidesheath Slender in patients with small vessels.
Interested in participating?
Request Info18 year–85 year
All sexes
Interventional
Not applicable
Changzhou Wujin People's Hospital, Changzhou, Jiangsu, China
The safety and efficacy of coronary angiography and percutaneous coronary intervention via distal transradial access (dTRA) have been confirmed by a large number of studies, but there are still few studies on its safety and efficacy in patients with small vessels (distal radial artery diameter < 2.0mm). The 6-French Glidesheath Slender, with its smaller outer diameter, should be more suitable for patients with small vessels. To this end, we plan to conduct a single-center, adaptive, randomized controlled trial enrolling 594 patients aged 18-85 years old with distal radial artery diameters <2.0 mm and ≥1.0 mm who are scheduled to undergo coronary angiography and percutaneous coronary intervention via the distal radial artery approach in our center. The study employed a stratification-block randomized design. Stratification was performed based on patient gender, with a block size of 4 within each stratum. Eligible patients were randomly assigned in a 1:1 ratio to either the 6-French Glidesheath Slender group or the 6-French conventional sheath group.
The primary endpoint of the study was distal radial artery occlusion assessed by vascular ultrasound 24 hours postoperatively. Secondary endpoints included puncture success rate, procedure success rate, number of punctures, puncture time, total procedural time, visual analogue scale pain scores during sheath placement, bleeding, hematoma, arteriovenous fistula, finger numbness, and conventional radial artery occlusion at 24 hours postoperatively.
An interim analysis will be conducted when 50% of the total sample size (297 patients) is enrolled, with subsequent sample size adjustments based on preliminary study results.
The results of this study will provide evidence for the safety and efficacy of 6-French Glidesheath Slender for coronary angiography and percutaneous coronary intervention in patients with small vessels via distal transradial access, and provide information for the selection of the best sheath equipment for patients with small vessels.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Coronary angiography and percutaneous coronary intervention was performed in participants with small vessels (DRA < 2.0 mm) via the distal transradial access using a 6-French Glidesheath Slender sheath.
Other names: 6-French Glidesheath Slender
Coronary angiography and percutaneous coronary intervention was performed in participants with small vessels (DRA < 2.0 mm) via the distal transradial access using a 6-French Conventional sheath.
Other names: 6-Fr Conventional sheath
Time frame: 24 hours postoperatively.
The dRAO is defined as the absence of blood flow in the distal radial artery assessed by the doppler ultrasound.
Time frame: Periprocedural
Puncture success is defined as complete insertion of the artery sheath.
Time frame: Periprocedural
Procedure success is defined as the whole procedure was completed from the same access.
Time frame: Periprocedural
The number of punctures is defined as the number of attempts made before a successful puncture.
Time frame: Periprocedural
Puncture time is defined as the time from the end of local anaesthesia to the sheath completely implanted into the vessel.
Time frame: Periprocedural
Procedural time is defined as the time from the initiation of the puncture to the completion of the procedure.
Time frame: Periprocedural
With a 10-cm straight line divided into 10 equal parts to rate pain with 0 indicating no pain and 10 for extreme pain.
Time frame: 24 hours postoperatively
Bleeding events are defined according to the BARC criteria.
Time frame: 24 hours postoperatively
Haematoma was assessed according to the mEASY( A modified version of the Early Discharge After Transradial Stenting of Coronary Arteries Study) classification.
Time frame: 24 hours postoperatively.
Number of participants with the arteriovenous fistula is assessed by the doppler ultrasound 24 hours postoperatively.
Time frame: 24 hours postoperatively
Number of participants with the finger numbness 24 hours postoperatively.
Time frame: 24 hours postoperatively
The cRAO is defined as the absence of blood flow in the conventional radial artery assessed by the doppler ultrasound.
Contact information is provided by the study sponsor or research team.
feng F li, MD
CONTACT
gaojun GJ cai, PhD
CONTACT
Cai gaojun, MD
Other
Safety and Efficacy of 6-French Glidesheath Slender in Coronary Angiography and Percutaneous Coronary Intervention Via Distal Transradial Access in Patients With Small Vessels: A Single-Center, Adaptive, Randomized Controlled Study
Acronym: DISTAL-SV
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