BVS Calcified: Eighteen months Angiographic and Clinical Follow up of Everolimus eluting bioresorbable vascular scaffold in calcified lesions.

Until now, the Absorb bioresorbale vascular scaffold (BVS) was mainly used in
non-complex coronary lesions. Little is known about the performance of these
scaffolds in calcified lesions.
A calcified lesion is one of the predictors of stent malposition and can
preclude late stent thrombosis. There is not much literature about invasive
follow up in calcified lesions.

Therefore, for the subgroup of patients with more complex calcified coronary
lesions we would like to further investigate scaffold apposition and scaffold
performance after BVS placement by, instead of a CT-scan, performing
angiography with invasive imaging using both OCT and IVUS at eighteen months
post-procedure. Using these techniques, we can superiorly evaluate the
scaffold in the calcified lesions since evaluation of calcified lesions by
multislice CT are limited due to the blooming artifact.

Primary Objective:
The objectives of this study are to assess lumen, scaffold, vessel dimension,
malapposition and tissue coverage as assessed by quantitative angiography,
intravascular optical coherence tomography and intravascular ultrasound imaging
18 months after implantation of the ABSORB everolimus eluting scaffold in
calcified lesions.


Secondary Objective:
The secondary objective of the present investigation is the evaluation of
clinical outcomes including death, myocardial infarction, target lesion
revascularization and scaffold thrombosis after implantation of the Absorb BVS
in calcified lesions.

We will conduct a single center, single arm, investigator-driven cohort study
aiming to evaluate status of the BVS in calcified lesions using invasive
coronary imaging 18 months post index procedure.

We will include a total of 30 patients who received BVS in calcified lesion(s)
during the index procedure. Patients had to present with NSTEMI, stable or
unstable angina or silent ischemia caused by de novo stenotic, calcified
lesion(s) in a native previous untreated coronary artery. The investigated
subjects will undergo coronary artery catheterization with OCT and IVUS at
eighteen months post procedure. There will be clinical follow-up at 30 days, 6
months, 1 year, 18 months and 2, 3, 4, 5 years.

Patients will ondergo invasive imaging met OCT and IVUS eightteen months after
their indexPCI. Rate of major complications using IVUS/ OCT are low. The risk
associated with this study is the standard risk of a diagnostic coronary
angiogram with the use of an intravascular imaging catheter and the risk of
major complications is reported to be inferior to 2%.
The potential benefit for the patients will be an accurate follow-up 18-months
after an index PCI allowing the investigation of the status of the implanted
device and the investigation of the possible progression of the atherosclerotic
disease.