Coronary Artery Disease
Conditions
Keywords
Bifurcation lesion, Percutaneous coronary intervention
Brief summary
The purpose of this study is to establish the optimal strategy for stenting in coronary bifurcation lesion.
Detailed description
The current study is designed as a multicenter, randomized and prospective study aiming to compare the effect of two-stenting and simple stenting techniques in patients with complex bifurcation lesions. Based on the previous studies, the rate of 1-year target lesion failure events was around 14% after PCI with provisional stenting. And our previous data showed that this event at 12-month after two-stenting procedure was 7%. Considering the lost to follow-up, it is anticipated that up to 660 patients will be enrolled in the trial. All patients will have repeat angiography at 13 months, with clinical follow-up to 5 years.
Interventions
PROCEDUREPercutaneous coronary intervention
Sponsors
Nanjing First Hospital, Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Provision of informed consent prior to any study specific procedures; * Men and women 18 years and older;. * Established indication to PCI according to the guidelines of American Heart Association and American College of Cardiology; * Native coronary lesion suitable for drug-eluting stent placement; * True bifurcation lesions (Medina 0,1,1/1,1,1); * Reference vessel diameter in side branch ≥2.5mm by visual estimation; * Complex bifurcation lesions based on DEFINITION study.
Exclusion criteria
* Pregnancy and breast feeding mother; * Co-morbidity with an estimated life expectancy of \< 50 % at 12 months; * Scheduled major surgery in the next 12 months; * Inability to follow the protocol and comply with follow-up requirements or any other reason that the investigator feels would place the patient at increased risk; * Unable to provide written informed consent, or fail to follow the protocol; * Previous enrolment in coronary intervention device investigation during the study period; * Patient with STEMI within 24-hour from the onset of chest pain to admission; * Restenosis bifurcation lesions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target lesion failure | 12 months | Combined end point of: cardiac death, target-vessel myocardial infarction (MI), or target lesion revascularization (TLR). |
Secondary
| Measure | Time frame |
|---|---|
| Target-vessel myocardial infarction | 12 months |
| Target lesion revascularisation | 12 months |
| Target vessel revascularisation | 12 months |
| Stent thrombosis | 12 months |
| Cardiac death | 12 months |
Other
| Measure | Time frame | Description |
|---|---|---|
| Late lumen loss | 13 months | The late lumen loss was defined as the difference between post- and follow-up minimal lumen diameter (MLD) |
| In-stent restenosis | 13 months | In-stent restenosis was defined as ≥50% diameter stenosis at the follow-up angiogram. |
| Acute gain | Intraoperative | The acute gain was defined as the difference between post- and preprocedural minimal lumen diameter (MLD) |
Countries
China
Outcome results
None listed