Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00376571
Status:
COMPLETED
Last Update Posted:
2016-09-26
First Post:
2006-09-14
Brief Title:
Nordic Bifurcation Study How to Use Drug Eluting Stents DES in Bifurcation Lesions
Sponsor:
Aarhus University Hospital Skejby
Organization:
Aarhus University Hospital Skejby
Study Overview
Official Title:
Nordic Bifurcation Study How to Use Drug Eluting Stents DES in Bifurcation Lesions A Strategy of Routine Stenting Both Main Vessel and Side Branch Versus a Strategy of Routine Main Vessel Stenting and Optional Treatment of Side Branch
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BIFI
Brief Summary:
How to use drug eluting stents DES in bifurcation lesions A strategy of routine stenting of both main vessel and side branch versus a strategy of routine main vessel stenting and optional treatment of side branch A randomized Nordic multicenter study including 400 patients with angina pectoris with clinical angiographic follow-up
Detailed Description:
Design
Randomized open multicentre trial
Patients
Number 400
Inclusion criteria
Stable or unstable AP
Bifurcation lesion of LADdiagonal Cxobtuse marginal RCA-PDAposterolateral branch or LMCxLAD in a right dominant system
Diameter of main vessel by visual estimate 25 mm
Diameter of side branch by visual estimate 20 mm
Signed informed consent
Exclusion criteria
ST-elevation Acute Myocardial infarction AMI within 24 hours
Expected survival 1 year
S-creatinine 200 Umoll
Allergy to Aspirin Clopidogrel or Ticlopidine
Allergy to sirolimuspaclitaxel
Left main bifurcation in a non-right dominant system
Randomization
Treatment strategy routine stenting of both main vessel and side branch versus routine main vessel stenting and optional treatment of side branch
Primary end-point
Combined end-point of cardiac death myocardial infarction stent thrombosis or TVR after 6 months
Secondary end-point
Clinical
1 MACE cardiac death myocardial infarction stent thrombosis or TVR during hospital period after 1 and 8 months
2 Cardiac death during hospital period after 1 6 and 8 months 3 Myocardial infarction during hospital period after 1 6 and 8 months 4 Stent thrombosis during hospital period after 1 6 and 8 months 5 TVR during hospital period after 1 6 and 8 months 6 Total death during hospital period after 1 6 and 8 months 7 TLR during hospital period after 1 6 and 8 months 8 Myocardial infarction related to index procedure 9 CCS angina score after 6 and 8 months
Angiographic
1 Angiographic restenosis 50 diameter stenosisof main vessel and occlusion of side branch
2 Late loss of main vessel and side branch after 8 months
3 Percentual diameter stenosis of main vessel and side branch after 8 months
4 Angiographic restenosis 50 diameter stenosis rate of main vessel and side branch after 8 months
End-point evaluation
Primary and secondary end-points will be assessed by an independent end-point committee The end-point committee will consist of experienced interventional cardiologists Detailed end-point definitions
Q-wave myocardial infarction Appearance of a new Q-wave in two or more contiguous leads on ECG
Non-Q-wave myocardial infarction Infarction which is considered present in a patient having clinical angiographic electrocardiographic andor laboratory evidence of myocardial necrosis with an ECG showing no new Q-waves
Procedure related myocardial infarction A threefold increase or CK-MB or Troponin-TI
Target lesion revascularization Coronary bypass operation with grafting or PCI of index lesion
Target vessel revascularization Coronary bypass operation with grafting or PCI of index vessel
Stent thrombosis Thrombotic occlusion of index stentstents
Vessel measurement
1 Proximal reference diameter Vessel diameter proximal to lesion 2 Distal reference diameter Vessel diameter distal to lesion 3 Reference diameter Mean of proximal and distal vessel diameter 4 Percentual diameter stenosis Reference diameter - minimal luminal diameterreference diameter in percent
Angiographic restenosis 50 diameter stenosis
Angiographic core lab
The index and the follow-up angiograms will be assessed blindly at the QCA core lab at Department of Cardiology Skejby Hospital DK-8200 Aarhus N Denmark
Definition of index angiography The angiography obtained during the PCI procedure will be used as index angiography
Definition of follow-up angiography After 8 months a conventional diagnostic angiography will be performed and the projections used at the index angiography will be repeated
Steering committee
The steering committee will consist of one or two investigators from each center All steering committee members will have full access to the database and will participate in the interpretation of data
Progress of the study
The progress of the study will be checked on a weekly basis by the steering committee They will receive and evaluate data on inclusion rate and the primary end-point event rate Further the steering committee will receive and evaluate the weekly safety data on the rate of stent thrombosis in the two groups
Statistics and data management
The statistical analyses will be performed by UNI-C University of Aarhus
Primary end-point The composite of the primary end-point at 6 months follow-up will be analyzed by the Kaplan-Meier method Differences between the event-free survival curves will be compared with the use of the Wilcoxon and log-rank tests Two-sided test is used and the p-value considered to indicate significance will be 005
Secondary end-points and other parameters For continuous variables differences between the treatment groups will be evaluated by analysis of variance or Wilcoxons rank-sum test For discrete variables differences will be expressed as counts and percentages will be analyzed with Fishers exact test Secondary end-points will be assessed after 8 months Two-sided test is used and the p-value considered to indicate significance will be 005
Safety
For safety reasons stent thrombosis after one month will be monitored continuously A stent thrombosis rate of 5 in any of the treatment groups will necessitate premature termination of the trial
Analysis population
Results are analyzed according to the intention-to-treat principle ie patients randomized to a certain group will be followed and assessed irrespectively of the actual treatment Protocol violations will be noted and the responsible centers notified
Sample size calculation
With an expected primary end-point event rate of 30 in the stenting main vessel and side branch group an alpha of 5 and a power of 80 a reduction of primary end-point event rate to 15 in the optional side branch treatment group can be detected with 200 patients in each group
Randomization procedure
The patient will be randomized at the beginning of the PCI procedure and before any insertion of wire or balloons
There will be a block randomization according to centre and a stratification according to sex age70 years diabetes use of GPIIbIIIa blocker and - angiographic follow-up
The patients will be computer randomized by a 24 hour telephone service The PARAVOX system will be used
Monitoring of the study
Data will be monitored according to the GCP rules by independent professionals During the trial the monitor will have regular contacts with the trial sites including visits to ensure that the trial is conducted and documented properly in compliance with the protocol GCP and applicable regulatory requirements
Publication
Results will be published in an international cardiovascular journal Publication and author issues will be decided by the steering committee on basis of general involvement in the study core lab function end-point committee membership ect and of number of included patients
Randomized open multicentre trial
Patients
Number 400
Inclusion criteria
Stable or unstable AP
Bifurcation lesion of LADdiagonal Cxobtuse marginal RCA-PDAposterolateral branch or LMCxLAD in a right dominant system
Diameter of main vessel by visual estimate 25 mm
Diameter of side branch by visual estimate 20 mm
Signed informed consent
Exclusion criteria
ST-elevation Acute Myocardial infarction AMI within 24 hours
Expected survival 1 year
S-creatinine 200 Umoll
Allergy to Aspirin Clopidogrel or Ticlopidine
Allergy to sirolimuspaclitaxel
Left main bifurcation in a non-right dominant system
Randomization
Treatment strategy routine stenting of both main vessel and side branch versus routine main vessel stenting and optional treatment of side branch
Primary end-point
Combined end-point of cardiac death myocardial infarction stent thrombosis or TVR after 6 months
Secondary end-point
Clinical
1 MACE cardiac death myocardial infarction stent thrombosis or TVR during hospital period after 1 and 8 months
2 Cardiac death during hospital period after 1 6 and 8 months 3 Myocardial infarction during hospital period after 1 6 and 8 months 4 Stent thrombosis during hospital period after 1 6 and 8 months 5 TVR during hospital period after 1 6 and 8 months 6 Total death during hospital period after 1 6 and 8 months 7 TLR during hospital period after 1 6 and 8 months 8 Myocardial infarction related to index procedure 9 CCS angina score after 6 and 8 months
Angiographic
1 Angiographic restenosis 50 diameter stenosisof main vessel and occlusion of side branch
2 Late loss of main vessel and side branch after 8 months
3 Percentual diameter stenosis of main vessel and side branch after 8 months
4 Angiographic restenosis 50 diameter stenosis rate of main vessel and side branch after 8 months
End-point evaluation
Primary and secondary end-points will be assessed by an independent end-point committee The end-point committee will consist of experienced interventional cardiologists Detailed end-point definitions
Q-wave myocardial infarction Appearance of a new Q-wave in two or more contiguous leads on ECG
Non-Q-wave myocardial infarction Infarction which is considered present in a patient having clinical angiographic electrocardiographic andor laboratory evidence of myocardial necrosis with an ECG showing no new Q-waves
Procedure related myocardial infarction A threefold increase or CK-MB or Troponin-TI
Target lesion revascularization Coronary bypass operation with grafting or PCI of index lesion
Target vessel revascularization Coronary bypass operation with grafting or PCI of index vessel
Stent thrombosis Thrombotic occlusion of index stentstents
Vessel measurement
1 Proximal reference diameter Vessel diameter proximal to lesion 2 Distal reference diameter Vessel diameter distal to lesion 3 Reference diameter Mean of proximal and distal vessel diameter 4 Percentual diameter stenosis Reference diameter - minimal luminal diameterreference diameter in percent
Angiographic restenosis 50 diameter stenosis
Angiographic core lab
The index and the follow-up angiograms will be assessed blindly at the QCA core lab at Department of Cardiology Skejby Hospital DK-8200 Aarhus N Denmark
Definition of index angiography The angiography obtained during the PCI procedure will be used as index angiography
Definition of follow-up angiography After 8 months a conventional diagnostic angiography will be performed and the projections used at the index angiography will be repeated
Steering committee
The steering committee will consist of one or two investigators from each center All steering committee members will have full access to the database and will participate in the interpretation of data
Progress of the study
The progress of the study will be checked on a weekly basis by the steering committee They will receive and evaluate data on inclusion rate and the primary end-point event rate Further the steering committee will receive and evaluate the weekly safety data on the rate of stent thrombosis in the two groups
Statistics and data management
The statistical analyses will be performed by UNI-C University of Aarhus
Primary end-point The composite of the primary end-point at 6 months follow-up will be analyzed by the Kaplan-Meier method Differences between the event-free survival curves will be compared with the use of the Wilcoxon and log-rank tests Two-sided test is used and the p-value considered to indicate significance will be 005
Secondary end-points and other parameters For continuous variables differences between the treatment groups will be evaluated by analysis of variance or Wilcoxons rank-sum test For discrete variables differences will be expressed as counts and percentages will be analyzed with Fishers exact test Secondary end-points will be assessed after 8 months Two-sided test is used and the p-value considered to indicate significance will be 005
Safety
For safety reasons stent thrombosis after one month will be monitored continuously A stent thrombosis rate of 5 in any of the treatment groups will necessitate premature termination of the trial
Analysis population
Results are analyzed according to the intention-to-treat principle ie patients randomized to a certain group will be followed and assessed irrespectively of the actual treatment Protocol violations will be noted and the responsible centers notified
Sample size calculation
With an expected primary end-point event rate of 30 in the stenting main vessel and side branch group an alpha of 5 and a power of 80 a reduction of primary end-point event rate to 15 in the optional side branch treatment group can be detected with 200 patients in each group
Randomization procedure
The patient will be randomized at the beginning of the PCI procedure and before any insertion of wire or balloons
There will be a block randomization according to centre and a stratification according to sex age70 years diabetes use of GPIIbIIIa blocker and - angiographic follow-up
The patients will be computer randomized by a 24 hour telephone service The PARAVOX system will be used
Monitoring of the study
Data will be monitored according to the GCP rules by independent professionals During the trial the monitor will have regular contacts with the trial sites including visits to ensure that the trial is conducted and documented properly in compliance with the protocol GCP and applicable regulatory requirements
Publication
Results will be published in an international cardiovascular journal Publication and author issues will be decided by the steering committee on basis of general involvement in the study core lab function end-point committee membership ect and of number of included patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None