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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Long introducer 6Fr-25cm | Experimental | The investigators will perform transradial coronary angiography and percutaneous coronary interventions using long introducer sheath 6Fr-25cm |
|
| Short introducer 6Fr-10cm | Active Comparator | The investigators will perform transradial coronary angiography and percutaneous coronary interventions using short introducer sheath 6Fr-10cm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Long introducer sheath | Procedure | The investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-25cm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Radial Artery Occlusion | Participants who diagnosed a radial artery occlusion with color Doppler ultrasound. | up to 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sergey V Popov | Tomsk National Research Medical Center of the Russian Academy of Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tyumen Cardiology Research Center, Tomsk National Research Medical Center, Russian Academy of Science | Tyumen | 625026 | Russia |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
One hundred patients who underwent coronary angiography (CAG) and/or percutaneous coronary intervention (PCI) with a transradial approach at the Cardiology Research Center in 2019 were enrolled in the study and randomized into two groups.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Radial Artery Occlusion | Participants who diagnosed a radial artery occlusion with color Doppler ultrasound. | Posted | Count of Participants | Participants | up to 10 days |
|
The period of time over which adverse event data were collected is 10 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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For the analysis of results in the main group, 1 participant was unavailable due to transfer to another hospital because of developed acute cerebrovascular accident.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Stanislav Sapozhnikov | Tyumen Cardiology Research Center, Tomsk National Research Medical Center, Russian Academy of Science, Tomsk, Russia | +79091919191 | stas_ss@bk.ru |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 11, 2019 | Nov 25, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 11, 2019 | Nov 25, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Short introducer sheath | Procedure | The investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-10cm |
|
| 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. | up to 10 days |
| Time of the Introducer Insertion | Time from start punction of the radial artery to full insertion of the introducer | up to 10 days |
| Time of the Procedure | Time from insertion of the introducer to finish the procedure | up to 10 days |
| Fluoroscopy Time | Fluoroscopy time, sec | up to 10 days |
| Total Air Kerma | Total air kerma, mGy | 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 | up to 10 days |
| Number of Participants With Median Nerve Neuritis | Rate of access site complications during percutaneous procedures performed via a transradial approach | 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. | up to 10 days |
| 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Signed informed consent document | Count of Participants | Participants |
|
| Repeated radial access | Count of Participants | Participants |
|
| Diabetes mellitus | Count of Participants | Participants |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
| Taking anticoagulants | Participants who took anticoagulants | Count of Participants | Participants |
|
| CAG | Patients who underwent coronary angiography (CAG) . | Count of Participants | Participants |
|
| PCI | Participants who underwent percutaneous coronary intervention (PCI). | Count of Participants | Participants |
|
| Ad hoc PCI | Participants who underwent immediate PCI after CAG. | Count of Participants | 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. | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | up to 10 days |
|
|
|
| Secondary | Time of the Introducer Insertion | Time from start punction of the radial artery to full insertion of the introducer | Posted | Median | Inter-Quartile Range | seconds | up to 10 days |
|
|
|
| Secondary | Time of the Procedure | Time from insertion of the introducer to finish the procedure | Posted | Median | Inter-Quartile Range | seconds | up to 10 days |
|
|
|
| Secondary | Fluoroscopy Time | Fluoroscopy time, sec | Posted | Median | Inter-Quartile Range | seconds | up to 10 days |
|
|
|
| Secondary | Total Air Kerma | Total air kerma, mGy | Posted | Median | Standard Deviation | 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 | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | up to 10 days |
|
|
|
| 0 |
| 49 |
| 0 |
| 49 |
| 0 |
| 49 |
| EG001 | 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 | 0 | 50 | 0 | 50 | 0 | 50 |
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| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |