Primary Objective:To compare the fate of the struts in front of the side-branch and intimal bridge formation using optical coherence tomography after treatment with the bioresorbable everolimus eluting vascular scaffold of coronary bifurcation…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
OCT endpoints
o Incomplete strut apposition in the bifurcation region at baseline, at 12
months, 24 months and 36 months
o Number of embedded and protruded struts per region at baseline, 12, 24
months and 36 months
o Incomplete strut coverage in the bifurcation region at 12, 24 months and 36
months
o Number of non-apposed side branch (NASB) struts at baseline at 12, 24
months and 36 months
o Tissue in-between NASB struts at 12 and 36 months
o Appearance of jailed side branch struts on three-dimensional OCT at baseline,
12, 24 months and 36 months including the V, T, H, double V, double T and
double H shapes.
o Mean/Minimal Scaffold diameter/area at baseline, 12, 24 months and 36 months
o Mean/Minimal Lumen diameter/area at baseline, 12, 24 months and 36 months
o Neointima thickness at 12 and 36 months; in total and per segment (proximal
end distal main branch; bifurcation region).
o Scaffold pattern irregularities at baseline, 12, 24 months and 36 months
o Incomplete strut apposition in the bifurcation region at baseline, 12 months,
24 months and 36 months between re-crossing through the distal compartment and
other compartments.
o Number of non-apposed side branch (NASB) struts at baseline 12 months, 24
months and 36 months between re-crossing through the distal compartment and
other compartments.
o Appearance of jailed side branch struts on three-dimensional OCT at baseline
12 months, 24 months and 36 months including the V, T, H, double V, double T
and double H shape between re-crossing through the distal compartment and other
compartments.
Angiographic endpoints
o Proximal 5mm SB% diameter stenosis (DS) postnitrate at baseline, 12, 24
months and 36 months
o In-segment Late Loss (LL) postnitrate at 12 months, 24 months and at 36
months
o Proximal LL postnitrate at 12 months, 24 months and at 36 months
o Distal LL postnitrate at 12 months, 24 months and at 36 months
o In-scaffold/in-stent, in-segment, proximal and distal MLD postnitrate at
baseline, 12 months, 24 months and at 36 months
o In-scaffold/in-stent, in-segment, proximal and distal % diameter stenosis
(DS) postnitrate at baseline, 12 months, 24 months and at 36 months
o In-scaffold/in-stent, in segment, proximal and distal angiographic binary
restenosis rate postnitrate at 12 months, 24 months and at 36 months
Secondary outcome
nvt
Background summary
Based on previous studies on the ABSORB BVS, the scaffold received C.E. mark in
December 2010 and is since then
commercially available (n Europe. Since this release there is lot of discuss
ion whether bifurcation lesions, with a sidebranch of >2mm, can be treated
with ABSORB BVS in the same way as with metallic stents. This discussion is
mainly driven by the fact that lesions with a sidebranch of 2mm ware excluded
trom previous trials, some observational data has been presented, however no
expert consensus exist about the use of ABSORB BVS in bifurcation lesions. The
use of bioresorbable vascullar scaffold in coronary bifurcation lesions could
have substantial advantages compared to metallic stent, it could prevent
permanent obstruction of a side branch after resorption of the struts in front
of a sidebranch.
To increase insight in the use of the ABSORB BVS in coronary bifurcation
lesions we will perform a a randomised study between ABSORB BVS and Xience
metallic stent in coronary bifurcation lesions and asses the fate of the struts
in front of the sidebranch in patient with or without fenestation towards the
sidebranch with intravascular imaging (optical coherence tomography).
Study objective
Primary Objective:
To compare the fate of the struts in front of the side-branch and intimal
bridge formation using optical coherence tomography after treatment with the
bioresorbable everolimus eluting vascular scaffold of coronary bifurcation
lesions with and without side-branch fenestration.
Secondary Objectives:
To compare the angiographic result in the side-branch ostium after treatment of
the main branch with the bioresorbable everolimus eluting vascular scaffold 1.
with and 2. without fenestration and post-dilatation of the side-branch.
Study design
Prospective, randomized (1:1), international, multicenter, evaluation of
consecutive patients undergoing an elective percutaneous coronary intervention
in (a) coronary bifurcation lesion(s) with ABSORB BVS placement. This study
involves the collection of baseline demographic, clinical, angiographic and
optical coherence tomography data, as well as angiographic and optical
coherence tomography follow-up data.
Intervention
lntervention of interest is either fenestration or no fenestration of the stent
towards the sidebranch.
Study burden and risks
Patients will undergo an OCT pullback after stent placement, to allow this
pullback a wire will be placed in the coronary artery.The risk of a wire is a
dissection of the coronary artery of spasm of the artery, this occurs in 2-3%
of the patients. Very severe complications, like a myocardial infarction,
stroke or death occur in les than 0.1% of the patients (1:1000). These
complications occur mostly in patients known with severe cardiac conditions, we
expect no severe complications in our study given the fact that we will not
include patients with severe cardiac illnesses.
The coronaryangiography after 12 or 24 or 36 months there is also a small risk
of bleeding, especcially at the access site of the guiding catheter (wrist or
groin).
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
o Subject has a bifurcation lesion involving a side-branch larger than 2 mm and having main branch involvement (Medina 0,0,1 lesions are excluded)
o Subject must agree to undergo all clinical investigation plan-required follow-up visits and to undergo follow-up angiography and optical coherence tomography
o Subject is able to verbally confirm understanding and he/she or his/her legally authorized representative provides written informed consent prior to any Clinical Investigation related procedure,as approved by the appropriate Ethics Committee.
Exclusion criteria
o Subject is younger than 18 years of age
o Subject is presenting with a STEMI
o Subject has a true bifurcation lesion where a priori two scaffold/stent strategy is planned.
o Subject has known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, antiplatelet medication specified for use in the study (clopidogrel, prasugrel and ticagrelor, inclusive), everolimus, poly (L-lactide), poly (DL-lactide), cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.
o Known renal insufficiency (eg. estimated Glomerular Filtration Rate (eGFR) <60mL/min/1.73m2 or serum creatinine level of >2.5mg/dL or subject on dialysis)
o Subject with a limited life expectancy less than one year.
o Subject is belonging to a vulnerable population (per investigator*s , e.g., subordinate hospital staff) or subject unable to read or write.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL50172.018.14 |