This study evaluates estimate impact of introducers length during endovascular coronary procedures on rate of a radial artery occlusion. For half of participants will use short introducers, while for other will use long introducers during transradial coronary intervention.
The transradial approach for coronary angiography and interventions is increasingly utilized around the world. Radial artery occlusion is the most common significant complication after transradial catheterization, with incidence varying between 1% and 10%. Endothelial injury of the radial artery and decrease in blood flow after sheath and catheter insertion appear to contribute to thrombus formation and are predisposing factors for radial artery occlusion. Procedural factors can predict and influence radial artery occlusion incidence. Sheath size and its relation to radial artery diameter, as well as the utilization of specific pharmacological agents (such as anticoagulants and vasodilators) have been studied. But, impact of Introducer sheath length on the rate of a radial artery occlusion has not been studied. The investigators suggest that, longer introducer sheath sizes can prevented the vascular damage and a pro-thrombotic environment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
100
The investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-25cm
The investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-10cm
Tyumen Cardiology Research Center, Tomsk National Research Medical Center, Russian Academy of Science
Tyumen, Russia
Number of Participants With Radial Artery Occlusion
Participants who diagnosed a radial artery occlusion with color Doppler ultrasound.
Time frame: up to 10 days
Number of Participants With a Hematoma, Stage I
Rate of access site complications during percutaneous procedures performed via a transradial approach. Local hematomas are classified according to the following scale: I - diameter not more than 5 cm, II - not more than 10 cm, III - not more than 10 cm, but not higher than the elbow, IV - above the elbow, V - with the threat of hand ischemia \[Bertrand, O. F., De Larochelliere, R., Rodes-Cabau, J., Proulx, G., Gleeton, O., Manh Nguyen, C., Dery J.P., Barbeau G., Noel B., Larose E., Poirier P., Roy L. A Randomized Study Comparing Same-Day Home Discharge and Abciximab Bolus Only to Overnight Hospitalization and Abciximab Bolus and Infusion After Transradial Coronary Stent Implantation. Circulation, 2006 114(24), 2636-2643.doi:10.1161/circulationaha.106.638627\]. Hematomas more than stage I were not recorded in both groups.
Time frame: up to 10 days
Rate of Conversion of Needle Type
Rate of conversion type of Needle type during percutaneous procedures performed via a transradial approach.
Time frame: up to 10 days
Time of the Introducer Insertion
Time from start punction of the radial artery to full insertion of the introducer
Time frame: up to 10 days
Time of the Procedure
Time from insertion of the introducer to finish the procedure
Time frame: up to 10 days
Fluoroscopy Time
Fluoroscopy time, sec
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Time frame: up to 10 days
Total Air Kerma
Total air kerma, mGy
Time frame: up to 10 days
Number of Participants With a Perforation / Dissection of a Radial Artery.
Rate of access site complications during percutaneous procedures performed via a transradial approach
Time frame: up to 10 days
Number of Participants With Median Nerve Neuritis
Rate of access site complications during percutaneous procedures performed via a transradial approach
Time frame: up to 10 days
Number of Participants With a Bleeding of the Puncture Site.
Rate of access site complications during percutaneous procedures performed via a transradial approach.
Time frame: up to 10 days