Primary Objective: To compare the fate of the struts in front of the side-branch and intimal bridge formation after treatment with optical coherence tomography between the bioresorbable everolimus eluting vascular scaffold and XIENCE family…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
o Incomplete strut apposition in the bifurcation region at 25 months
Secondary outcome
OCT endpoints
o Incomplete strut apposition in the bifurcation region at baseline
o Number of embedded and protruded struts per region at baseline and 25 months
o Incomplete strut coverage in the bifurcation region at 25 months
o Number of jailed side branch struts (2D-OCT) at baseline and at 25 months
o Tissue in-between non-apposed side branch struts at 25 months
o Number of jailed side branch struts (3D-OCT) at baseline and at 25 months; V,
T, H, double V, double T, and double H.
o Mean/Minimal Lumen diameter/area at baseline and 25 months
o Mean/Minimal Stent/Scaffold diameter/area at baseline and 25 months
o Neointima thickness in the bifurcation region at 25 months
o Scaffold pattern irregularities at baseline and 25 months
Angiographic endpoints
o In-segment Late Loss (LL) postnitrate at 25 months
o Proximal LL postnitrate at 25 months
o Distal LL postnitrate at 25 months
o In-scaffold/in-stent, in-segment, proximal and distal MLD postnitrate at
baseline and at 25 months
o In-scaffold/in-stent, in-segment, proximal and distal % diameter stenosis
(DS) postnitrate at baseline and at 25 months
o Proximal 5mm SB% diameter stenosis (DS) postnitrate at baseline and at 25
months
o In-scaffold/in-stent, in-segment, proximal and distal angiographic binary
restenosis rate postnitrate at 25 months
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 in Europe. Since this
release there is lot of discussion 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 were excluded from 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 assess 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 after treatment with optical coherence tomography between the
bioresorbable everolimus eluting vascular scaffold and XIENCE family everolimus
eluting coronary stent system in the treatment of (a) coronary bifurcation
lesion(s) with and without side-branch fenestration.
Secondary Objective:
To compare the angiographic result between the bioresorbable everolimus eluting
vascular scaffold and XIENCE family everolimus eluting coronary stent system in
the treatment of (a) coronary bifurcation lesion(s) with and without
side-branch fenestration.
Study design
The AIDA bifurcation strategy study is a substudy of the Amsterdam
Investigator-intiateD ABSORB all-comers trial (AIDA). This study is a
prospective, randomized (1:1) evaluation of consecutive patients undergoing PCI
in (a) coronary bifurcation lesion(s) participating in the AIDA trial. Patients
will first be randomized according the AIDA protocol (ABSORB BVS vs Xience
Family DES), hereafter a second randomization will be performed to either
side-branch fenestration
Intervention
Intervention 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
complication 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 coronary angiography after 25 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 is enrolled in the Amsterdam Investigator-InitiateD Absorb strategy trial
o Subject has a bifurcation lesion involving a side-branch greater than 2 mm (excluding Medina class 0,0,1 where the is no main-branch involvement)
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 known hypersensitivity or contraindication to contrast 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 is belonging to a vulnerable population (per investigator*s judgment, 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 | NL47960.018.14 |