Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT00914199 |
| Other study ID # |
20070005 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 2, 2007 |
| Est. completion date |
November 2021 |
Study information
| Verified date |
January 2021 |
| Source |
Aarhus University Hospital Skejby |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Should we, or should we not, perform dilatation of the side branch through the main vessel
stent, if there is acceptable blood flow in the side branch?
Description:
Design:
- Randomised open multicentre trial
Patients:
- Number 477
Randomisation:
- Treatment strategy kissing or no kissing balloon post-dilatation
Primary end point:
- Combined end point of: cardiac death, index lesion myocardial infarction, stent
thrombosis or target lesion revascularisation after 6 months.
Secondary end points:
- Clinical
- MACE (cardiac death, myocardial infarction, stent thrombosis or target vessel
revascularisation) during hospital period, after 1, 8, and 14 months, 2, 3 and, 5 years.
- Cardiac death during hospital period, after 1, 8 and 14 months, 2, 3 and, 5 years.
- Myocardial infarction during hospital period, after 1, 8 and 14 months, 2, 3 and, 5
years.
- Stent thrombosis during hospital period, after 1, 8 and 14 months, 2 and 3 years.
- Target vessel revascularisation during hospital period, after 1, 8 and 14 months, 2 and
3 years.
- Total mortality during hospital period, after 1, 6, 8 and 14 months, 2 and 3 years.
- Target lesion revascularisation during hospital period, after 1, 8 and 14 months, 2 and
3 years.
- Myocardial infarction related to the index procedure.
- CCS angina score after 1, 8 and 14 months, 2, 3 and, 5 years.
- Angiographic. Angiographic significant stenosis (>50%) of main vessel and/or occlusion
of the side branch after 8 months.
- Late loss of main vessel and side branch after 8 months.
- Angiographic significant stenosis (>50%) of main vessel and/or side branch after 8
months.
- Angiographic significant stenosis (>50%) of main vessel after 8 months.
- Angiographic significant stenosis (>50%) of side branch after 8 months.
- Markers. All patients with stable angina pectoris and the patients with unstable angina
pectoris, who have normal markers (CK-MB or TnT/TnI) before and after the procedure,
will enter into the marker study.
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 cardiologists. The detailed end
point definitions are the following:
- 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 and/or laboratory evidence of
myocardial necrosis with an ECG showing no new Q waves
- Procedure related myocardial infarction. A > threefold increase of CK-MB or
Troponin-T/I.
- 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. Stent thromboses are categorized as acute, sub acute, late and very
late and as definite, probable and possible (see appendix).
- Vessel measurement. Proximal reference diameter: Vessel diameter proximal to
lesion.Distal reference diameter: Vessel diameter distal to lesion.Percentual diameter
stenosis: (Reference diameter - minimal luminal diameter)/reference diameter in percent.
- Angiographic restenosis. > 50% diameter stenosis.
- Recommendations for re-revascularization. Main vessel:Angina pectoris, CCS 1 related to
index lesion and stenosis diameter >40%* Stenosis diameter >70%*. Side branch: AP, CCS
>1 related to index lesion and stenosis diameter >40%*
- The stenosis diameter is evaluated by eyeballing.
Angiographic core lab:
- The index and follow-up angiograms will be asses by the QCA-laboratories at Department
of Cardiology, Paul Stradins Clinical Hospital, Riga, Latvia and Department of
Cardiology B, Aarhus University Hospital Skejby, 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 after 0.1 mg intracoronary
nitroglycerine. The index angiograms will be stored on CD and sent by mail to the
angiographic core laboratories.
Steering committee:
- The steering committee members will be selected on basis of participation in the study.
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, Aarhus.
- Primary end point. The composite end point in the two groups at six month follow-up will
be described by Kaplan-Meier event graphs. The event graphs in the two groups will be
compared by a log-rank test. A two-sided test is used. A p-value of < 0.05 is considered
significant.
- Secondary end points and other variables. For continuous variables, differences between
the treatment groups will be evaluated by Wilcoxon's rank-sum test. For discrete
variables, differences will be expressed as counts and in percent and will be analyzed
with the chi-square or Fisher's exact test. Secondary end points will be assessed after
6 or 8 months. Two- sided test is used and the p-value considered indicating
significance will be 0.05.
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 study.
Analysis population:
- The results will be analyzed according to the intention-to-treat principle, i.e.
patients randomized to a certain group will be followed and assessed irrespectively of
the actual treatment. Protocol violations will be noted and the responsible centres
notified.
Sample size calculation:
- A total of 225 patients will be included in each group, in total 450 patients. This is
based on the following: We expect a MACE rate of 2% in the group of dilatation of side
branch through main vessel stent and of 8% in the group without side branch dilatation
through main vessel stent. With an alfa of 5% and a strength of 80%, 206 patients will
be needed in each group (two-sided chi square test) to demonstrate this difference. By
including 225 patients in each group, a possible dropout before follow-up is counted
for.
Randomization procedure:
- The patient will be randomized after successful stenting of the main vessel. There will
be a block randomization according to country and a stratification according to sex, age
> 70 years, diabetes, +/- measurement of FFR and +/- angiographic follow-up. The
patients will be computer randomized by a 24 hour telephone service.
Monitoring of the study:
- The study will be monitored according to the GCP rules by independent professionals.
Publication:
- Results, positive as well as negative, 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 etc.) and of number of included patients.
