Coronary Artery Disease
Conditions
Keywords
Distal radial artery, Small vessel, Ultrasound, Distal radial artery occlusion, Radial artery occlusion, Visual analog scale, Safety, Efficacy
Brief summary
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.
Detailed description
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.
Interventions
DEVICEPerforming coronary angiography and percutaneous coronary intervention via the distal transradial access in patients with small vessels (DRA < 2.0 mm) using a 6-Fr Glidesheath Slender sheath.
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.
DEVICEPerforming coronary interventional procedures via the distal radial artery in patients with small vessels ( DRA diameter < 2.0 mm ) using a 6-Fr Conventional sheath.
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.
Sponsors
Cai gaojun, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Because cardiac interventionalists need to know which arterial sheaths to use during the procedure, therefore it is not possible to blind them to this information. But, the investigators responsible for outcome assessment and the personnel responsible for preoperative and postoperative radial artery ultrasound evaluations will be blind of this.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Age between 18 and 85 years * Palpable pulses in both the distal radial artery and conventional radial artery * All patients signed informed consent forms prior to procedure
Exclusion criteria
* Ultrasound assessment of the distal radial artery diameter ≥2.0mm or \<1.0mm * Height ≥185.0cm * Patients with acute ST-segment elevation myocardial infarction, cardiogenic shock, or hemodynamic instability * Contraindications for puncture of the distal radial artery * Patients with Raynaud's syndrome * Patients with coagulation disorders or hematologic diseases * Patients currently enrolled in other clinical studies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distal radial artery occlusion(dRAO) | 24 hours postoperatively. | The dRAO is defined as the absence of blood flow in the distal radial artery assessed by the doppler ultrasound. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Puncture success | Periprocedural | Puncture success is defined as complete insertion of the artery sheath. |
| Procedure success | Periprocedural | Procedure success is defined as the whole procedure was completed from the same access. |
| Number of punctures | Periprocedural | The number of punctures is defined as the number of attempts made before a successful puncture. |
| Puncture time(second) | Periprocedural | Puncture time is defined as the time from the end of local anaesthesia to the sheath completely implanted into the vessel. |
| Procedural time(minute) | Periprocedural | Procedural time is defined as the time from the initiation of the puncture to the completion of the procedure. |
| Visual Analogue Scale (VAS) pain scores(0-10) during sheath placement | 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. |
| Bleeding | 24 hours postoperatively | Bleeding events are defined according to the BARC criteria. |
| Haematoma | 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. |
| Arteriovenous fistula | 24 hours postoperatively. | Number of participants with the arteriovenous fistula is assessed by the doppler ultrasound 24 hours postoperatively. |
| Finger numbness | 24 hours postoperatively | Number of participants with the finger numbness 24 hours postoperatively. |
| Conventional radial artery occlusion (cRAO) | 24 hours postoperatively | The cRAO is defined as the absence of blood flow in the conventional radial artery assessed by the doppler ultrasound. |
Countries
China
Contacts
CONTACTgaojun GJ cai, PhD
CONTACTfeng F li, MD
PRINCIPAL_INVESTIGATORhaiyan HY zhang, BS
Wujin Hospital Affiliated with Jiangsu University.
Outcome results
None listed