Individualization Of Treatment; How To Use; Required Equipment; System Preparation - ivascular BTK Instructions D'utilisation

• Death
• Acute myocardial infarction
• Unstable angina
• Ictus / embolism / thrombosis
• Emergency bypass surgery
• Endocarditis
• Allergic reaction to the metals, to drugs, antiplatelet agents/anticoagulant
agents or contrast media
• Artery spasm
• Hemodynamic deterioration
• Arrhythmia
• Aneurysm or pseudo-aneurysm
• Infections
• Total occlusion of the artery / thrombosis / stent embolization
• Reocclusion of the treated area: re-stenosis
• Perforation or dissection of the treated area
• Arteriovenous fistula
• Hypotension/hypertension
• Local haemorrhaging with haematoma at the insertion site
Possible adverse events associated with daily administration of sirolimus
not previously indicated are:
• Anaemia
• Arthralgia
• Diarrhoea
• Interstitial lung disease
• Abnormal liver function
• Hypercholesterolaemia
• Hypertrygliceridaemia
• Hypersensitivity, including anaphylactic reactions
• Hypopotassaemia
• Leucopoenia
• Lymphoma and other malignant neoplasms
• Thrombocytopaenia

9. Individualization of treatment

Before using the product, the risks and benefits should be considered for
each patient. Factors that should be kept in mind include an evaluation of
the risk of using antiplatelet therapy. Special attention should be paid to
patients with gastritis or recently active peptic ulcers.

10. How to Use

10.1 Required equipment

• Heparinised normal saline solution.
• Contrast medium (use contrast media indicated for intravascular use).
• Proper medical prescription to the procedure.
• 0.014" guidewire; do not use any other size of guidewire.
• Introducer with haemostatic valve whose size is equal or larger than 5F
(except for 4 and 4.5 mm stent diameters, where 6F is recommended).
Do not use smaller sizes as these might damage or leave useless the
catheter.
• Guiding catheter or long introducer.
• Haemostatic valve.
• Three-way stopcock.
• Extension lines
• Inflation device (manual pump with built-in manometer).
• Several standard 10-20cc syringes with saline solution for washing the
system.

10.2 System Preparation

angiolite BTK
• The stent diameter must coincide with the reference vessel diameter,
as its length with lesion length. It is preferably to be a slightly longer to
ensure full lesion coating.
• Remove the catheter from the protective dispenser. Check that it is the
right size. Remove the protective pod and stylet from the balloon. Wash
the guide lumen with sterile saline solution by means of injection with a
syringe from the tip until it outcomes from the guidewire insertion port.
Do not dry with gauze.
• Inspect the stent to ensure it is located between the radiopaque
markers; if it is noted that it has moved, do not use it.
• Attach a three-way stopcock to an extension line and the extension line
to the luer hub of the delivery system. Optionally, the inflation pump can
be connected to the three-way stopcock.
• Close the air passage through the balloon.
• Attach a 10-20ml syringe with a third part of saline solution to the three-
way stopcock.
• Open the three-way stopcock connection between the syringe and the
catheter.
• Withdraw the syringe plunger upwards allowing the air bubbles exiting
to the liquid (it is recommended that the syringe be in a vertical position).
• When bubbles stop coming in, leave a meniscus of solution in the key
and close the three-way stopcock at the catheter part. Remove the
syringe.
• Connect the inflation device with 1/3 of 1:1 contrast medium and saline
solution mixture (duly 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 connections 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.

10.3 Implantation Technique

Preliminary steps
• Insert the introducer according to the manufacturer's instructions.
• Connect the haemostatic valve to the guiding catheter hub or long
introducer, maintain the valve closed. Insert the guiding catheter through
the introducer or directly through the long introducer according to the
manufacturer's instructions and make sure it is located at the peripheral
artery entrance. Inject contrast liquid through the guiding catheter or the
long introducer to ensure it is correctly positioned giving access to the
artery.
• Open the haemostatic valve for 0.014" guidewire passage through.
Once the guide crosses the key valve, seal it to avoid blood loss. Place
the 0.014" guidewire through the lesion according to percutaneous
intervention techniques, by means of fluoroscopy techniques to
determine its position all times. Use a contrast liquid infusion to
determine that the guidewire is properly positioned.
Implantation technique
• Pre-dilatation with a peripheral dilatation balloon catheter is recommended.
Follow the instructions of the balloon catheter manufacturer for lesion pre-
dilatation. Then, proceed to stent implantation.
• Insert the proximal end of the guidewire 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 guidewire through the guiding
catheter until it reaches the lesion to treat, by means of fluoroscopic
imaging. Ensure that the guidewire 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.
3
• 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 compliance
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 pressure 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 guidewire 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 guidewire through the dilated stenosis for 30 minutes after
angioplasty. In case of any thrombus observed around the stent,
administer thrombolytic agents. When the angiography confirms
dilatation, carefully withdraw the guidewire and the balloon catheter
through the connector.
• Withdraw the guiding catheter through the introducer.
• Leave the introducer placed until the haemodynamic profile returns to
normality. Perform suture as usually.
Further dilatation of stented segments
• If the stent size results inadequate with respect to vessel diameter,
stent post-dilatation technique may be applied with a larger balloon.
To do this, a balloon catheter is inserted into the stented area (it is not
needed to be compliant) and dilatation is performed according to the
manufacturer's recommendations.
• As a further recommendation, a "small stent" must not be post-dilated
over 3 mm, a "medium stent" must not be post-dilated over 4.25mm and
a "large stent" must not be post-dilated over 5.25mm.
Unexpanded stent withdrawal
• If the stent does not cross the lesion, it may need to be removed
without expanding. If any resistance is not detected, check that the
guiding catheter is coaxially situated with respect to the stent and
carefully withdraw the stent towards the guiding catheter. If any unusual
resistance is noticed during its withdrawal, extract the whole system as a
single unit by means of fluoroscopic imaging according to the indicated
instructions in part 5.3 of this leaflet.
10.4 Antiplatelet therapy
• The optimal duration for double antiplatelet treatment is unknown, but
clinical practice guidelines recommend administering aspirin indefinitely
with clopidogrel for at least 6 months, stretching the treatment with
clopidogrel up to 12 months in patients with low risk of bleeding.
• It is very important that the patient follows recommendations related
to antiplatelet treatment after the intervention. Early interruption of the
antiplatelet medication described could increase the risk of thrombosis,
myocardial infarction or death. Before carrying out a percutaneous
peripheral intervention (PPI), if a surgical or dental operation is planned for
which it is necessary to interrupt antiplatelet treatment, the doctor and the
patient should consider whether a drug-eluting stent and the associated
antiplatelet treatment is the appropriate choice for the PPI. After the PPI, if
carrying out a surgical or dental operation were to be prescribed, the risks
and benefits of said operation should be weighed against the possible risk
of an early suspension of antiplatelet treatment.
11. Warranty
The device and all its components have been designed, manufactured,
tested and packed with a maximum level of precaution. LVD Biotech
warrants the device until its expiration date, provided the packaging is not
broken, tampered with or damaged.
ESPAÑOL
1. Descripción del producto
El stent periférico con liberación de Sirolimus Angiolite BTK de LVD Biotech
SL, es un stent fabricado a partir de una aleación de Cobalto Cromo
denominada L605, a la que se ha aplicado un recubrimiento formado por
una mezcla de sirolimus y polímeros. El stent se presenta premontado en el
EN
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