Status:
COMPLETED
Two-stent vs Provisional Stenting Techniques for Patients With Complex Coronary Bifurcation Lesions
Lead Sponsor:
Nanjing First Hospital, Nanjing Medical University
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 lesion...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2019
Estimated Enrollment :
660 Patients enrolled
Trial Details
Trial ID
NCT02284750
Start Date
December 1 2015
End Date
December 1 2019
Last Update
December 16 2019
Active Locations (1)
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1
Nanjing First Hospital
Nanjing, Jiangsu, China, 210006