A Prospective, Multi-center, Randomized Trial Comparing Two-stent With Provisional Stenting Techniques for Patients With Complex Coronary Bifurcation Lesions
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Nanjing First Hospital, Nanjing Medical University
- Enrollment
- 660
- Locations
- 1
- Primary Endpoint
- Target lesion failure
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Shaoliang Chen
Vice President
Nanjing First Hospital, Nanjing Medical University
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Target lesion failure
Time Frame: 12 months
Combined end point of: cardiac death, target-vessel myocardial infarction (MI), or target lesion revascularization (TLR).
Secondary Outcomes
- Stent thrombosis(12 months)
- Target-vessel myocardial infarction(12 months)
- Target vessel revascularisation(12 months)
- Cardiac death(12 months)
- Target lesion revascularisation(12 months)