Ischaemic Heart Disease, Ischemic Heart Disease
Conditions
Brief summary
The purpose is to compare median two-year clinical outcome after OCT guided vs. standard guided revascularization of patients requiring complex bifurcation stent implantation
Detailed description
Coronary bifurcation lesions with stenosis in a large side branch may require complex stent implantation techniques with an elevated risk of suboptimal treatment results. Intra vascular optical coherence tomography (OCT) enables improved procedural control of correctable factors and may lead to optimized implantation results. It is unknown if routine, systematic use of OCT scans during complex bifurcation stenting improves clinical outcome but present available evidence indicates advantages of OCT guidance that could translate into improved clinical outcome. Hypothesis: Systematic OCT guided revascularization of patients with bifurcation lesions requiring complex stent implantation provides superior two-year clinical outcome compared to standard revascularization by PCI. Methods: Investigator initiated and investigator sponsored, randomized (1:1), controlled, prospective, multicenter, superiority trial. Randomization is stratified for 1) Left main or non-Left main artery disease, and 2) up-front planned one-stent technique with kissing balloon inflation, or a two-stent technique. Systematic OCT guidance is detailed for five complex stent implantation techniques. Standard treatment is angiographic based with optional use of intravascular ultrasound (IVUS).
Interventions
PROCEDUREAngiographic guided PCI
Angiographic guided PCI is percutaneous coronary intervention performed by standard angiographic guided techniques
PROCEDUREOCT guided PCI
OCT guided PCI is percutaneous coronary intervention (PCI) guided by intra vascular optical coherence tomography (OCT) scans
Sponsors
Aarhus University Hospital Skejby
Abbott
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. Angiographic inclusion criteria: * Native coronary bifurcation de novo lesion * More than 50% diameter stenosis in the main vessel (MV) * More than 50% diameter stenosis in the side branch (SB) within 5 mm of the ostium. * Reference size at least 2.75 mm in the main vessel (MV) and ≥2.5 mm in the SB. Functional inclusion criteria: Functional significance of the main vessel lesion or documented ischemia of the main vessel territory or other objective documentation of lesion significance. Objective evidence of ischemia is required for all treated lesions except for lesions with more than 80% diameter stenosis that may be considered significant. Procedural inclusion criteria: Indication for two-stent technique or one-stent technique with kissing balloon inflation
Exclusion criteria
* STEMI within 72 hours * Cardiogenic shock * Prior coronary artery bypass grafting (CABG) or planned CABG * Renal failure with glomerular filtration rate (GFR) \<50 mL/min per 1.73 m2 * Active bleeding or coagulopathy * Life expectancy \< 2 years * Ejection fraction \< 30% * New York Heart Association (NYHA) class \> II * Relevant allergies (aspirin, clopidogrel, ticagrelor, contrast compounds, everolimus). Angiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Combined endpoint of major adverse cardiac events (MACE) | 24 months | Composite of cardiac death, target lesion myocardial infarction, ischaemic driven target lesion revascularization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-PCI minimal lumen diameter in the treated side branch vessel segment | Baseline, just after final baseline procedure | Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the treated (stent or balloon) side branch vessel segment |
| Post-PCI minimal lumen diameter in the proximal main vessel edge segment | Baseline, just after final baseline procedure | Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the proximal main vessel edge segment (within 5 mm from the stent) |
| Post-PCI minimal lumen diameter in the distal main vessel edge segment | Baseline, just after final baseline procedure | Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the distal main vessel edge segment (within 5 mm from the stent) |
| Post-PCI minimal lumen diameter in the side branch vessel edge segment | Baseline, just after final baseline procedure | Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the side branch vessel edge segment (within 5 mm from stent or balloon) |
| Post-PCI minimal lumen diameter in the stented bifurcation core segment | Baseline, after final baseline procedure | Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the stented bifurcation core segment |
| Post-PCI minimal lumen diameter in the stented distal main vessel ostium segment | Baseline, just after final baseline procedure | Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the stented distal main vessel ostium segment |
| Post-PCI minimal lumen diameter in the treated side branch vessel ostium segment | Baseline, just after final baseline procedure | Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the treated side branch vessel ostium segment |
| Post-PCI diameter stenosis in the stented proximal main vessel segment | Baseline, just after final baseline procedure | Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the stented proximal main vessel segment |
| Post-PCI diameter stenosis in the stented distal main vessel segment | Baseline, after final baseline procedure | Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the stented distal main vessel segment |
| Post-PCI diameter stenosis in the treated side branch vessel segment | Baseline, after final baseline procedure | Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the treated (stent or balloon) side branch vessel segment |
| Post-PCI diameter stenosis in the proximal main vessel edge segment | Baseline, just after final baseline procedure | Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the proximal main vessel edge segment (within 5 mm from the stent) |
| Post-PCI diameter stenosis in the distal main vessel edge segment | Baseline, just after final baseline procedure | Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the distal main vessel edge segment (within 5 mm from the stent) |
| Post-PCI diameter stenosis in the side branch vessel edge segment | Baseline, just after final baseline procedure | Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the side branch vessel edge segment (within 5 mm from stent or balloon) |
| Post-PCI diameter stenosis in the stented bifurcation core segment | Baseline, just after final baseline procedure | Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the stented bifurcation core segment |
| Post-PCI diameter stenosis in the stented distal main vessel ostium segment | Baseline, just after final baseline procedure | Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the stented distal main vessel ostium segment |
| Post-PCI diameter stenosis in the treated side branch ostium segment | Baseline, just after final baseline procedure | Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in the treated side branch ostium segment |
| Post-PCI minimal lumen diameter in non-bifurcation target stented segment | Baseline, after final baseline procedure | Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in non-bifurcation target stented segment |
| Post-PCI minimal lumen diameter in non-bifurcation target proximal edge segment | Baseline, after final baseline procedure | Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in non-bifurcation target proximal edge segment (within 5mm fra stent) |
| Post-PCI minimal lumen diameter in non-bifurcation target distal edge segment | Baseline, just after final baseline procedure | Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in non-bifurcation target distal edge segment (within 5mm fra stent) |
| Post-PCI diameter stenosis in non-bifurcation target stented segment | Baseline, just after final baseline procedure | Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in non-bifurcation target stented segment |
| Post-PCI diameter stenosis in non-bifurcation target proximal edge segment | Baseline, just after final baseline procedure | Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in non-bifurcation target proximal edge segment |
| Post-PCI diameter stenosis in non-bifurcation target distal edge segment | Baseline, just after final baseline procedure | Post-PCI diameter stenosis by quantitative coronary analysis (QCA) in non-bifurcation target distal edge segment |
| Study bifurcation oriented composite endpoint | 1 month | Composite of cardiac death, target bifurcation myocardial infarction, target bifurcation revascularisation |
| Patient oriented composite endpoint | 1 month | Composite of all-cause mortality, myocardial infarction, any revascularisation, stroke |
| All-cause mortality | 1 month | Death of any cause including cardiac deaths and non-natural causes of death |
| Cardiac death | 1 month | Death due to cardiac causes or if death is not clearly attributable to other non-cardiac causes |
| Myocardial infarction | 1 month | Procedure and non-procedure related myocardial infarction |
| Stent Thrombosis | 1 month | Definite, possible or probable |
| Target lesion myocardial infarction | 1 month | Myocardial infarction related to an index treated lesion |
| Target lesion revascularisation | 1 month | Coronary artery bypass grafting or PCI of target lesion |
| Target bifurcation myocardial infarction | 1 month | Myocardial infarction related to the index bifurcation |
| Target bifurcation revascularisation | 1 month | Coronary artery bypass grafting or PCI of target bifurcation |
| Target vessel revascularisation | 1 month | Coronary artery bypass grafting or PCI of target vessel |
| Any revascularisation | 1 month | Any repeat revascularization except staged revascularization planned during the index procedure |
| CCS angina class | 1 month | Canadian Cardiovascular Society (CCS) grading of angina pectoris |
| Contrast volume | Baseline, after final baseline procedure | Contrast volume |
| Procedure time | Baseline, after final baseline procedure | Procedure time |
| Fluoroscopy time | Baseline, after final baseline procedure | Fluoroscopy time |
| Number of stents implanted in target lesion | Baseline, after final baseline procedure | Number of stents implanted in target lesion |
| Number of stents implanted in non-target lesion | Baseline, after final baseline procedure | Number of stents implanted in non-target lesion |
| Total stent length in target lesion | Baseline, just after final baseline procedure | Total stent length in target lesion |
| Total stent length in total | Baseline, just after final baseline procedure | Total stent length in total |
| Procedural success | Baseline, just after final baseline procedure | TIMI III flow and less than 30% diameter stenosis in target segments |
| OCT-guiding group: Successful final OCT acquisition in MV | Baseline, just after final baseline procedure | For OCT-guided enrollments. Successful final OCT acquisition in main vessel. Success defined as analyzable stented segment. |
| OCT-guiding group: Successful final OCT acquisition in SB | Baseline, just after final baseline procedure | For OCT-guided enrollments. Successful final OCT acquisition in side branch. Success defined as analyzable stented segment. |
| OCT-guiding group: Successful treatment specific OCT acquisitions | Baseline, after final baseline procedure | OCT performed succesfully in protocol-defined vessels at all protocol-defined time-points during baseline procedure |
| Post-PCI minimal lumen diameter in the stented distal main vessel segment | Baseline, after final baseline procedure | Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the stented distal main vessel segment |
| Post-PCI minimal lumen diameter in the stented proximal main vessel segment | Baseline, after final baseline procedure | Post-PCI minimal lumen diameter by quantitative coronary analysis (QCA) in the stented proximal main vessel segment |
Countries
Belgium, Denmark, Estonia, Finland, Germany, Ireland, Italy, Latvia, Netherlands, Norway, Poland, Sweden, United Kingdom
Contacts
STUDY_CHAIREvald H Christiansen, MD, PhD
Aarhus University Hospital
Outcome results
None listed