Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00292305
Status:
COMPLETED
Last Update Posted:
2016-09-26
First Post:
2006-02-13
Brief Title:
Nordic Bifurcation Stent Technique Study BIF II
Sponsor:
Aarhus University Hospital Skejby
Organization:
Aarhus University Hospital Skejby
Study Overview
Official Title:
Crush- or Culotte Stenting of Bifurcation Lesions Using Drug Eluting Stents A Randomized Nordic Multicenter Study BIF II
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:
BIF II
Brief Summary:
This is a study of crush- or culotte stenting of bifurcation lesions using drug eluting stents This is 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
Randomization
Treatment strategy culotte technique or T-crush stenting
Primary end-point
Combined end point of cardiac death myocardial infarction stent thrombosis or TVR after 6 months
Secondary end points
Clinical
MACE cardiac death MI stent thrombosis or TVR during hospital period after 1 and 8 months
Cardiac death during hospital period after 1 6 and 8 months
Myocardial infarction during hospital period after 1 6 and 8 months
Stent thrombosis during hospital period after 1 6 and 8 months
TVR during hospital period after 1 6 and 8 months
Total death during hospital period after 1 6 and 8 months
TLR during hospital period after 1 6 and 8 months
Myocardial infarction related to index procedure
CCS-angina score after 6 and 8 months
Angiographic
Late loss of main vessel and side branch after 8 months
Percentual diameter stenosis of main vessel and side branch after 8 months
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
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 of CK-MBor Troponin-TI
Target lesion revascularization Coronary by-pass operation with grafting or PCI of index lesion
Target vessel revascularization Coronary by-pass operation with grafting or PCI of index vessel
Stent thrombosis Thrombotic occlusion of index stentstents
Vessel measurement Proximal reference diameter Vessel diameter proximal to lesion Distal reference diameter Vessel diameter distal to lesion Reference diameter Mean of proximal and distal vessel diameter 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 by the QCA core lab at the Department of Cardiology Skejby Hospital 8200 Aarhus N Denmark
Definition of index angiography
The angiography obtained during the PCI procedure will be used as index angiography
Follow-up angiography After 8 months conventional diagnostic angiography will be performed and the projections used at the index angiography will be repeated
Steering committee
The steering committee members will be selected on basis of participation in the study see below 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 three 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 points at six months follow-up will be analyzed by the Kaplan-Meier method Differences between the event-free survival curves for the three groups 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
200 patients will be included in each group with a total of 400 patients in the study This is based on the following We expect a MACE rate of 25 in the control group and 13 in the interventional group With an alfa of 5 and a strength of 80 167 patients will be needed in each group two-sided chi square test to demonstrate this difference By including 200 patients in each group a possible dropout before follow-up is counted for
Randomization procedure
The patient will be randomized before insertion of any stent Both main vessels and side branch may be wired and predilated before randomization
There will be a block randomization according to country a stratification according to sex age 70 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 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 the basis of general involvement in the study core lab function end point committee membership etc and on the number of included patients
Randomized open multicentre trial
Patients
Number 400
Randomization
Treatment strategy culotte technique or T-crush stenting
Primary end-point
Combined end point of cardiac death myocardial infarction stent thrombosis or TVR after 6 months
Secondary end points
Clinical
MACE cardiac death MI stent thrombosis or TVR during hospital period after 1 and 8 months
Cardiac death during hospital period after 1 6 and 8 months
Myocardial infarction during hospital period after 1 6 and 8 months
Stent thrombosis during hospital period after 1 6 and 8 months
TVR during hospital period after 1 6 and 8 months
Total death during hospital period after 1 6 and 8 months
TLR during hospital period after 1 6 and 8 months
Myocardial infarction related to index procedure
CCS-angina score after 6 and 8 months
Angiographic
Late loss of main vessel and side branch after 8 months
Percentual diameter stenosis of main vessel and side branch after 8 months
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
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 of CK-MBor Troponin-TI
Target lesion revascularization Coronary by-pass operation with grafting or PCI of index lesion
Target vessel revascularization Coronary by-pass operation with grafting or PCI of index vessel
Stent thrombosis Thrombotic occlusion of index stentstents
Vessel measurement Proximal reference diameter Vessel diameter proximal to lesion Distal reference diameter Vessel diameter distal to lesion Reference diameter Mean of proximal and distal vessel diameter 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 by the QCA core lab at the Department of Cardiology Skejby Hospital 8200 Aarhus N Denmark
Definition of index angiography
The angiography obtained during the PCI procedure will be used as index angiography
Follow-up angiography After 8 months conventional diagnostic angiography will be performed and the projections used at the index angiography will be repeated
Steering committee
The steering committee members will be selected on basis of participation in the study see below 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 three 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 points at six months follow-up will be analyzed by the Kaplan-Meier method Differences between the event-free survival curves for the three groups 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
200 patients will be included in each group with a total of 400 patients in the study This is based on the following We expect a MACE rate of 25 in the control group and 13 in the interventional group With an alfa of 5 and a strength of 80 167 patients will be needed in each group two-sided chi square test to demonstrate this difference By including 200 patients in each group a possible dropout before follow-up is counted for
Randomization procedure
The patient will be randomized before insertion of any stent Both main vessels and side branch may be wired and predilated before randomization
There will be a block randomization according to country a stratification according to sex age 70 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 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 the basis of general involvement in the study core lab function end point committee membership etc and on the 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