Coronary Artery Disease
Conditions
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.
Interventions
PROCEDURELong introducer sheath
The investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-25cm
PROCEDUREShort introducer sheath
The investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-10cm
Sponsors
Tomsk National Research Medical Center of the Russian Academy of Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age over 18 years old * Applicability of transradial approach
Exclusion criteria
* Failure of the transradial approach
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Radial Artery Occlusion | up to 10 days | Participants who diagnosed a radial artery occlusion with color Doppler ultrasound. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 Introducer Insertion | up to 10 days | Time from start punction of the radial artery to full insertion of the introducer |
| Time of the Procedure | up to 10 days | Time from insertion of the introducer to finish the procedure |
| Fluoroscopy Time | up to 10 days | Fluoroscopy time, sec |
| 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 Median Nerve Neuritis | 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. |
Countries
Russia
Contacts
PRINCIPAL_INVESTIGATORSergey V Popov
Tomsk National Research Medical Center of the Russian Academy of Sciences
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Long Introducer 6Fr-25cm The investigators will perform transradial coronary angiography and percutaneous coronary interventions using long introducer sheath 6Fr-25cm
Long introducer sheath: The investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-25cm | 50 |
| Short Introducer 6Fr-10cm The investigators will perform transradial coronary angiography and percutaneous coronary interventions using short introducer sheath 6Fr-10cm
Short introducer sheath: The investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-10cm | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | Long Introducer 6Fr-25cm | Short Introducer 6Fr-10cm | Total |
|---|---|---|---|
| Ad hoc PCI | 2 Participants | 6 Participants | 8 Participants |
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 13 Participants | 20 Participants | 33 Participants |
| Age, Categorical Between 18 and 65 years | 37 Participants | 30 Participants | 67 Participants |
| Age, Continuous | 58.04 years STANDARD_DEVIATION 11.163 | 63.46 years STANDARD_DEVIATION 9.265 | 60.75 years STANDARD_DEVIATION 10.563 |
| Body mass index | 31.5 kg/m^2 STANDARD_DEVIATION 5.5 | 31.8 kg/m^2 STANDARD_DEVIATION 6.2 | 31.6 kg/m^2 STANDARD_DEVIATION 5.8 |
| CAG | 44 Participants | 39 Participants | 83 Participants |
| Diabetes mellitus | 11 Participants | 10 Participants | 21 Participants |
| PCI | 4 Participants | 5 Participants | 9 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 50 Participants | 50 Participants | 100 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Russia | 50 participants | 50 participants | 100 participants |
| Repeated radial access | 14 Participants | 19 Participants | 33 Participants |
| Sex: Female, Male Female | 15 Participants | 22 Participants | 37 Participants |
| Sex: Female, Male Male | 35 Participants | 28 Participants | 63 Participants |
| Signed informed consent document | 50 Participants | 50 Participants | 100 Participants |
| Taking anticoagulants | 11 Participants | 19 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 49 | 0 / 50 |
| other Total, other adverse events | 0 / 49 | 0 / 50 |
| serious Total, serious adverse events | 0 / 49 | 0 / 50 |
Outcome results
Primary
Number of Participants With Radial Artery Occlusion
Participants who diagnosed a radial artery occlusion with color Doppler ultrasound.
Time frame: up to 10 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Long Introducer 6Fr-25cm | Number of Participants With Radial Artery Occlusion | 4 Participants |
| Short Introducer 6Fr-10cm | Number of Participants With Radial Artery Occlusion | 2 Participants |
Secondary
Fluoroscopy Time
Fluoroscopy time, sec
Time frame: up to 10 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Long Introducer 6Fr-25cm | Fluoroscopy Time | 82.0 seconds |
| Short Introducer 6Fr-10cm | Fluoroscopy Time | 69.5 seconds |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Long Introducer 6Fr-25cm | Number of Participants With a Bleeding of the Puncture Site. | 1 Participants |
| Short Introducer 6Fr-10cm | Number of Participants With a Bleeding of the Puncture Site. | 0 Participants |
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.
Time frame: up to 10 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Long Introducer 6Fr-25cm | Number of Participants With a Hematoma, Stage I | 8 Participants |
| Short Introducer 6Fr-10cm | Number of Participants With a Hematoma, Stage I | 8 Participants |
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
Time frame: up to 10 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Long Introducer 6Fr-25cm | Number of Participants With a Perforation / Dissection of a Radial Artery. | 0 Participants |
| Short Introducer 6Fr-10cm | Number of Participants With a Perforation / Dissection of a Radial Artery. | 0 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Long Introducer 6Fr-25cm | Number of Participants With Median Nerve Neuritis | 0 Participants |
| Short Introducer 6Fr-10cm | Number of Participants With Median Nerve Neuritis | 0 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Long Introducer 6Fr-25cm | Rate of Conversion of Needle Type | 5 Participants |
| Short Introducer 6Fr-10cm | Rate of Conversion of Needle Type | 0 Participants |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Long Introducer 6Fr-25cm | Time of the Introducer Insertion | 94 seconds |
| Short Introducer 6Fr-10cm | Time of the Introducer Insertion | 42.5 seconds |
Secondary
Time of the Procedure
Time from insertion of the introducer to finish the procedure
Time frame: up to 10 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Long Introducer 6Fr-25cm | Time of the Procedure | 448 seconds |
| Short Introducer 6Fr-10cm | Time of the Procedure | 350.5 seconds |
Secondary
Total Air Kerma
Total air kerma, mGy
Time frame: up to 10 days
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Long Introducer 6Fr-25cm | Total Air Kerma | 140.8 mGy | Standard Deviation 97.7 |
| Short Introducer 6Fr-10cm | Total Air Kerma | 128.2 mGy | Standard Deviation 71.3 |