Effect of Introducer Length on the Rate of Radial Artery Occlusion During Endovascular Coronary Procedures
- Conditions
- Coronary Artery Disease
- Interventions
- Procedure: Long introducer sheathProcedure: Short introducer sheath
- Registration Number
- NCT03854253
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- Age over 18 years old
- Applicability of transradial approach
- Failure of the transradial approach
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Long introducer 6Fr-25cm Long introducer sheath The investigators will perform transradial coronary angiography and percutaneous coronary interventions using long introducer sheath 6Fr-25cm Short introducer 6Fr-10cm Short introducer sheath The investigators will perform transradial coronary angiography and percutaneous coronary interventions using short introducer sheath 6Fr-10cm
- Primary Outcome Measures
Name Time Method Number of Participants With Radial Artery Occlusion up to 10 days Participants who diagnosed a radial artery occlusion with color Doppler ultrasound.
- Secondary Outcome Measures
Name Time Method Number of Participants With Median Nerve Neuritis up to 10 days Rate of access site complications during percutaneous procedures performed via a transradial approach
Time of the Introducer Insertion up to 10 days Time from start punction of the radial artery to full insertion of the introducer
Fluoroscopy Time up to 10 days Fluoroscopy time, sec
Number of Participants With a Hematoma, Stage I up to 10 days 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.
Rate of Conversion of Needle Type up to 10 days Rate of conversion type of Needle type during percutaneous procedures performed via a transradial approach.
Time of the Procedure up to 10 days Time from insertion of the introducer to finish the procedure
Total Air Kerma up to 10 days Total air kerma, mGy
Number of Participants With a Perforation / Dissection of a Radial Artery. up to 10 days Rate of access site complications during percutaneous procedures performed via a transradial approach
Number of Participants With a Bleeding of the Puncture Site. up to 10 days Rate of access site complications during percutaneous procedures performed via a transradial approach.
Trial Locations
- Locations (1)
Tyumen Cardiology Research Center, Tomsk National Research Medical Center, Russian Academy of Science
🇷🇺Tyumen, Russian Federation