Coronary Artery Disease Clinical Trial
— IntroLengthOfficial title:
Effect of Introducer Length on the Rate of Radial Artery Occlusion During Endovascular Coronary Procedures: а Pilot Randomized Clinical Trial
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.
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 |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Tyumen Cardiology Research Center, Tomsk National Research Medical Center, Russian Academy of Science | Tyumen |
Lead Sponsor | Collaborator |
---|---|
Tomsk National Research Medical Center of the Russian Academy of Sciences |
Russian Federation,
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 |
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