Effect of Introducer Length on the Rate of Radial Artery Occlusion During Endovascular Coronary Procedures

Coronary Artery Disease Clinical Trial

— IntroLength  

Official title:

Effect of Introducer Length on the Rate of Radial Artery Occlusion During Endovascular Coronary Procedures: а Pilot Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03854253
• Other study ID #: IntroLength
• Status: Completed
• Phase: N/A
• Start date: February 26, 2019
• Est. completion date: March 14, 2019

Study information

• Verified date: January 2020
• Source: Tomsk National Research Medical Center of the Russian Academy of Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 14, 2019
• Est. primary completion date: March 13, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age over 18 years old

• Applicability of transradial approach

Exclusion Criteria:

• Failure of the transradial approach

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Procedure:
• Long introducer sheath
The investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-25cm
• Short introducer sheath
The investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-10cm

Locations

Country	Name	City	State
Russian Federation	Tyumen Cardiology Research Center, Tomsk National Research Medical Center, Russian Academy of Science	Tyumen

Sponsors (1)

Lead Sponsor	Collaborator
Tomsk National Research Medical Center of the Russian Academy of Sciences

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Radial Artery Occlusion	Participants who diagnosed a radial artery occlusion with color Doppler ultrasound.	up to 10 days
Secondary	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.	up to 10 days
Secondary	Rate of Conversion of Needle Type	Rate of conversion type of Needle type during percutaneous procedures performed via a transradial approach.	up to 10 days
Secondary	Time of the Introducer Insertion	Time from start punction of the radial artery to full insertion of the introducer	up to 10 days
Secondary	Time of the Procedure	Time from insertion of the introducer to finish the procedure	up to 10 days
Secondary	Fluoroscopy Time	Fluoroscopy time, sec	up to 10 days
Secondary	Total Air Kerma	Total air kerma, mGy	up to 10 days
Secondary	Number of Participants With a Perforation / Dissection of a Radial Artery.	Rate of access site complications during percutaneous procedures performed via a transradial approach	up to 10 days
Secondary	Number of Participants With Median Nerve Neuritis	Rate of access site complications during percutaneous procedures performed via a transradial approach	up to 10 days
Secondary	Number of Participants With a Bleeding of the Puncture Site.	Rate of access site complications during percutaneous procedures performed via a transradial approach.	up to 10 days