7
purged), to the three-way stopcock and the extension line. Do not apply pressure as this might
dislodge the stent.
DANGER: If bubbles do not stop coming from the catheter into the syringe after 1 minute of negative
pressure, this may be a clear indication that the balloon catheter has leaks, is broken or the connec-
tions between the syringe and the three-way stopcock are not properly sealed. If bubbles continue to
be seen after checking the connections, do not use the device. Return the device to the manufacturer
or distributor for its inspection.
7.3. Implantation Technique
Preliminary steps
-
Insert the introducer according to the manufacturer’s instructions.
-
Connect the haemostatic valve to the guiding catheter hub, maintain the valve closed. Insert the
guiding catheter through the introducer according to the manufacturer’s instructions and make sure
it is located at the coronary artery entrance. Inject contrast liquid through the guiding catheter to
ensure it is correctly positioned giving access to the coronary artery.
-
Open the haemostatic valve for 0.014” guide wire passage through. Once the guide crosses the key
valve, seal it to avoid blood loss. Place the 0.014” guide wire through the lesion according to percu-
taneous intervention techniques, by means of fluoroscopy techniques to determine its position all
times. Use a contrast liquid infusion to determine that the guide wire is properly positioned.
Implantation technique
When the lesion diameter is so small, calcified or as tortuous that may compromise stent access, its
pre-dilatation with a coronary dilatation balloon catheter should be considered. Follow the instruc-
tions of the balloon catheter manufacturer for lesion dilatation. Then, proceed to stent implantation.
•
Insert the proximal end of the guide wire into the distal tip of the delivery system.
•
Open the haemostatic valve again to allow stent passage through the valve. Once the stent
has been run through it, close the valve. If any resistance is noted, do not advance the delivery
system through the haemostatic key. Avoid the haemostatic key valve damaging the catheter
shaft; which may subsequently affect the balloon in-deflation.
•
Carefully advance the stent system on the guide wire through the guiding catheter until it
reaches the lesion to treat, by means of fluoroscopic imaging. Ensure that the guide wire comes
out of the balloon catheter guide insertion port (approximately 25cm from the tip of the balloon
catheter).
•
Place the stent across the lesion situating the radiopaque markers on both sides of the lesion.
Use high-resolution fluoroscopy to verify that the stent has not been damaged or shifted during
its advance before its expansion.
•
Apply pressure for 15-30 seconds depending on the lesion, to completely expand the stent.
Do not exceed the rated burst pressure (RBP) indicated at the label and the compliance curve.
•
For an optimal expansion, the stent must be in contact with the artery, otherwise the stent
could move when the balloon is removed. The balloon diameter must be slightly higher than the
vessel diameter to allow stent elastic recoil once the balloon is deflated. Consult the compli-
ance table for proper expansion, due to too high size may also induce artery dissection.
•
Withdraw the plunger of the inflation device to deflate the balloon. Keep up the negative pres-
sure for between 15 and 30 seconds depending on the balloon size. Ensure that the balloon is
fully deflated (by means of fluoroscopy) before moving the catheter.
•
With negative pressure in the inflation device and with the guide wire still placed, withdraw
the catheter from the lesion. Keep the guide across the dilated stenosis.
•
Carry out an angiography through the guiding catheter to confirm suitable stenting.
•
Keep the guide wire through the dilated stenosis for 30 minutes after angioplasty. In case of
any thrombus observed around the stent, administer thrombolytic agents. When the angiog-
raphy confirms dilatation, carefully withdraw the guide wire and the balloon catheter through
the connector.
•
Withdraw the guiding catheter through the introducer
INSTRUCTIONS FOR USE
CoCr CORONARY STENT SYSTEM
architect
therapies for living
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