Primary Objective:To compare the fate of the struts in front of the side-branch using optical coherence tomography after treatment with 1. COMBO or 2. XIENCE stent using single stent strategy with side-branch fenestration in the treatment of (a)…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
OCT endpoints
o Appearance of overhanging struts in front of the side branch ostium on
three-dimensional OCT post-implantation and post-procedure measured by
cute-plane analysis
o Number of non-apposed side branch (NASB) struts post-implantation and
post-procedure
o Incomplete strut apposition in the bifurcation region post-procedure
o Mean/Minimal Stent diameter/area post-procedure
o Mean/Minimal Lumen diameter/area at baseline
o Stent pattern irregularities post-procedure
Angiographic endpoints
o Acute gain of proximal main branch (MB), distal MB and side branch (SB)
o In-stent, in-segment, % diameter stenosis proximal and distal MB and SB
post-nitrate pre-procedural
o Reference vessel diameter of MB
o In-stent, in-segment Dmax (maximum diameter) proximal and distal MB and
distal SB pre-procedural
3D angiographic endpoints
o The bifurcation angle
o Minimal lumen area (MLA, in mm2)
o Percentage area stenosis (%)
Secondary outcome
Cardiac death
myocardial infarction
revascularization
Background summary
Coronary artery bifurcation lesions constitute a complex lesion subgroup that
is encountered in 15-20% of all percutaneous coronary interventions (1).
Percutaneous treatment of coronary bifurcation lesion remain challenging in
interventional cardiology, with lower procedural success and increased rates of
long-term adverse cardiac events (1). Multiple technical strategies have been
proposed, but it has been generally accepted that provisional side-branch (SB)
stenting is a favoured approach (2, 3). A two-stent strategy did not have an
advantage over a one-stent strategy (4, 5). When SB dilatation is indicated
after provision stenting, a frequent used strategy is side branch fenestration
followed by proximal optimization technique (POT) (3).
The COMBO dual-therapy stent has not systematically been tested in bifurcation
lesions. But, due to the dual helix stent strut design, there is unsurpassed
sidebranchability. In addition, the strut width of COMBO is 90 µm and the
maximum stent cell opening is 4.50 mm. This all may contribute to a better
angiographic result after provisional stenting with COMBO in bifurcation
lesions than after XIENCE implantation.
Study objective
Primary Objective:
To compare the fate of the struts in front of the side-branch using optical
coherence tomography after treatment with 1. COMBO or 2. XIENCE stent using
single stent strategy with side-branch fenestration in the treatment of (a)
coronary bifurcation lesion(s).
Secondary Objective:
To compare the angiographic result of the main branch and side-branch after
treatment of the main branch with fenestration of the side-branch with 1. COMBO
stent to 2. XIENCE stent.
Study design
The DUTCH OPEN trial is a prospective, randomized (1:1), Dutch, multicenter
trial of consecutive elective patients undergoing percutaneous coronary
intervention in (a) coronary bifurcation lesion(s) with stent placement. This
study involves the collection of baseline demographic, clinical, angiographic
and optical coherence tomography data, as well as clinical follow-up data.
Study burden and risks
The PCI will take longer, after stent placement an OCT will be made. In
addition, patients will be contacted by Phone at 12 months after index
procedure. The OCT will come with additional risk: low blood pressure,
arithmia, acute vessel closure.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
Bifurcation lesion involving a side-branch larger than 2 mm and having main
branch involvement, which needs percutaneous coronary intervention with
stenting.
Exclusion criteria
Patients with a bifurcation lesie which needs a two stent strategy
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 | NL65342.018.19 |