Trial Outcomes & Findings for Effect of Introducer Length on the Rate of Radial Artery Occlusion During Endovascular Coronary Procedures (NCT NCT03854253)
NCT ID: NCT03854253
Last Updated: 2020-01-13
Results Overview
Participants who diagnosed a radial artery occlusion with color Doppler ultrasound.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
up to 10 days
Results posted on
2020-01-13
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
49
|
50
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Introducer Length on the Rate of Radial Artery Occlusion During Endovascular Coronary Procedures
Baseline characteristics by cohort
| Measure |
Long Introducer 6Fr-25cm
n=50 Participants
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
|
Short Introducer 6Fr-10cm
n=50 Participants
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
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
37 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Age, Continuous
|
58.04 years
STANDARD_DEVIATION 11.163 • n=5 Participants
|
63.46 years
STANDARD_DEVIATION 9.265 • n=7 Participants
|
60.75 years
STANDARD_DEVIATION 10.563 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Region of Enrollment
Russia
|
50 participants
n=5 Participants
|
50 participants
n=7 Participants
|
100 participants
n=5 Participants
|
|
Signed informed consent document
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Repeated radial access
|
14 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Diabetes mellitus
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Body mass index
|
31.5 kg/m^2
STANDARD_DEVIATION 5.5 • n=5 Participants
|
31.8 kg/m^2
STANDARD_DEVIATION 6.2 • n=7 Participants
|
31.6 kg/m^2
STANDARD_DEVIATION 5.8 • n=5 Participants
|
|
Taking anticoagulants
|
11 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
CAG
|
44 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
PCI
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ad hoc PCI
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 10 daysParticipants who diagnosed a radial artery occlusion with color Doppler ultrasound.
Outcome measures
| Measure |
Long Introducer 6Fr-25cm
n=49 Participants
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
|
Short Introducer 6Fr-10cm
n=50 Participants
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
|
|---|---|---|
|
Number of Participants With Radial Artery Occlusion
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: up to 10 daysRate 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.
Outcome measures
| Measure |
Long Introducer 6Fr-25cm
n=49 Participants
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
|
Short Introducer 6Fr-10cm
n=50 Participants
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
|
|---|---|---|
|
Number of Participants With a Hematoma, Stage I
|
8 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: up to 10 daysRate of conversion type of Needle type during percutaneous procedures performed via a transradial approach.
Outcome measures
| Measure |
Long Introducer 6Fr-25cm
n=49 Participants
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
|
Short Introducer 6Fr-10cm
n=50 Participants
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
|
|---|---|---|
|
Rate of Conversion of Needle Type
|
5 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 10 daysTime from start punction of the radial artery to full insertion of the introducer
Outcome measures
| Measure |
Long Introducer 6Fr-25cm
n=49 Participants
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
|
Short Introducer 6Fr-10cm
n=50 Participants
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
|
|---|---|---|
|
Time of the Introducer Insertion
|
94 seconds
Interval 67.5 to 162.5
|
42.5 seconds
Interval 33.0 to 65.3
|
SECONDARY outcome
Timeframe: up to 10 daysTime from insertion of the introducer to finish the procedure
Outcome measures
| Measure |
Long Introducer 6Fr-25cm
n=49 Participants
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
|
Short Introducer 6Fr-10cm
n=50 Participants
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
|
|---|---|---|
|
Time of the Procedure
|
448 seconds
Interval 337.5 to 633.0
|
350.5 seconds
Interval 307.0 to 506.8
|
SECONDARY outcome
Timeframe: up to 10 daysFluoroscopy time, sec
Outcome measures
| Measure |
Long Introducer 6Fr-25cm
n=49 Participants
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
|
Short Introducer 6Fr-10cm
n=50 Participants
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
|
|---|---|---|
|
Fluoroscopy Time
|
82.0 seconds
Interval 48.5 to 133.0
|
69.5 seconds
Interval 48.0 to 118.3
|
SECONDARY outcome
Timeframe: up to 10 daysTotal air kerma, mGy
Outcome measures
| Measure |
Long Introducer 6Fr-25cm
n=49 Participants
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
|
Short Introducer 6Fr-10cm
n=50 Participants
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
|
|---|---|---|
|
Total Air Kerma
|
140.8 mGy
Standard Deviation 97.7
|
128.2 mGy
Standard Deviation 71.3
|
SECONDARY outcome
Timeframe: up to 10 daysRate of access site complications during percutaneous procedures performed via a transradial approach
Outcome measures
| Measure |
Long Introducer 6Fr-25cm
n=49 Participants
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
|
Short Introducer 6Fr-10cm
n=50 Participants
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
|
|---|---|---|
|
Number of Participants With a Perforation / Dissection of a Radial Artery.
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 10 daysRate of access site complications during percutaneous procedures performed via a transradial approach
Outcome measures
| Measure |
Long Introducer 6Fr-25cm
n=49 Participants
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
|
Short Introducer 6Fr-10cm
n=50 Participants
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
|
|---|---|---|
|
Number of Participants With Median Nerve Neuritis
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 10 daysRate of access site complications during percutaneous procedures performed via a transradial approach.
Outcome measures
| Measure |
Long Introducer 6Fr-25cm
n=49 Participants
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
|
Short Introducer 6Fr-10cm
n=50 Participants
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
|
|---|---|---|
|
Number of Participants With a Bleeding of the Puncture Site.
|
1 Participants
|
0 Participants
|
Adverse Events
Long Introducer 6Fr-25cm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Short Introducer 6Fr-10cm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Stanislav Sapozhnikov
Tyumen Cardiology Research Center, Tomsk National Research Medical Center, Russian Academy of Science, Tomsk, Russia
Phone: +79091919191
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place