Compare median two-year clinical outcome after OCT guided vs. standard guided revascularization of patients requiring complex bifurcation treatment.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Combined endpoint of median two-year MACE (cardiac death, target lesion
myocardial infarction, ischemic driven target lesion revascularization)
Secondary outcome
Clinical endpoints:
All-cause mortality 1,12,24,36,48,60 and 120 months. Cardiac death, myocardial
infarction, stent thrombosis(definite/ possible/probable), myocardial
infarction or revascularization of target lesion/ bifurcation/vessel, any
revascularization and CSS angina class at 1,12,24,36,48 and 60 months.
Procedural endpoint:
Contrast volume, procedure time, fluoroscopy time, number of stent implanted in
target lesion, number of stents implanted in non-target lesion, total stent
length in target lesion, total stent length and procedural success (TIMI III
flow and less than 30% diameter stenosis in target segments)
OCT guided group: successful final OCT acquisition in main vessel/side branch.
Successful treatment specific to OCT acquisition.
Angiographic endpoints:
Target bifurcation: minimal luminal diameter and diameter stenosis post-PCI
(proximal edge, proximal MV, bifurcation core segment, distal MV ostium, distal
MV, distal edge, SB ostium, SB, SB edge)
Non-target lesions: minimal luminal diameter and diameter stenosis post PCI
(proximal edge, in-stent, distal edge)
Background summary
Coronary bifurcation lesions with stenosis in a large side branch may require
complex stent implantation techniques with an elevated risk of suboptimal
treatment results. Guiding of complex bifurcation treatment by angiography is
limited by a high degree of angiographic ambiguity in visualization of the
lesion, the side branch, stent expansion, stent apposition and wirer position.
The lack of adequate procedural guidance can lead to suboptimal treatment
associated with higher risk of clinical events during and after the procedure.
Intra vascular optical coherence tomography (OCT) provides visualization of the
vessel wall, vessel lumen, plaque components, dissections, stents and wires at
a very high resolution enabling precise measurements and stepwise verification
and optimization during complex PCI. If systematic use of OCT to optimize
complex bifurcation stenting improves clinical outcome remains unknown but it
is likely based on previous OCT trials.
Study objective
Compare median two-year clinical outcome after OCT guided vs. standard guided
revascularization of patients requiring complex bifurcation treatment.
Study design
OCTOBER is an randomized controlled, prospective, multicenter, superiority
trial. Randomization is two level-stratified: for planned two stent-treatment
or one-stent treatment with side branch treatment after main vessel stenting.
And for LMCA bifurcation or non-LMCA bifurcation lesion. The study is
investigator initiated and investigator sponsored research
Intervention
Intra vascular optical coherence tomography (OCT)
Study burden and risks
PCI of a bifurcation lesion is a high risk procedure, regardless of this study.
OCT is a proven safe procedure used in daily practice. Adding OCT guidance to
the PCI procedure extends the procedural time and slightly increases some of
the procedural risks (<1% chance on dissection, <0,1% risk (in this patient
selection) on kidney failure due to the extra use of contrast). We expect the
patients randomized to the OCT arm to benefit from a reduction of the risk on
MACE due to better positioning of the stent. Follow up will be done by phone
(or a clinical visit of the patient wish so) of which we expected not to be
considered as much of a burden.
Palle Juul-Jensens Boulevard 99
Aarhus N DK-8200
DK
Palle Juul-Jensens Boulevard 99
Aarhus N DK-8200
DK
Listed location countries
Age
Inclusion criteria
Stable angina pectoris, unstable angina pectoris, clinically stable non-STEMI.
Age >=18 yrs.
Abel to provide written Informed consent and willing to comply with the
specified follow-up contacts.
Exclusion criteria
STEMI within 72 hours
Cardiogenic shock
Prior CABG or planned CABG
Renal failure with GFR<50 mL/min per 1.73 m2
Active bleeding or coagulopathy
Life expectancy < 2 years
Ejection fraction < 30%
NYHA class > II
Relevant allergies (aspirin, clopidogrel, ticagrelor, contrast compounds,
everolimus).
Design
Recruitment
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 | NL63653.029.18 |