Clinical trial NCT02284750: Two-stent vs Provisional Stenting Techniques for Patients With Complex Coronary Bifurcation Lesions
Official title: A Prospective, Multi-center, Randomized Trial Comparing Two-stent With Provisional Stenting Techniques for Patients With Complex Coronary Bifurcation Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Bifurcation lesion
Percutaneous coronary intervention
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2014-11-06
Enrollment: 660
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Target lesion failure
timeFrame: 12 months
Secondary outcomes:
measure: Cardiac death
timeFrame: 12 months
measure: Target-vessel myocardial infarction
timeFrame: 12 months
measure: Target lesion revascularisation
timeFrame: 12 months
measure: Target vessel revascularisation
timeFrame: 12 months
measure: Stent thrombosis
timeFrame: 12 months
Other outcomes:
measure: Acute gain
timeFrame: Intraoperative
measure: In-stent restenosis
timeFrame: 13 months
measure: Late lumen loss
timeFrame: 13 months
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing First Hospital, Nanjing Medical University
name: Shao-Liang Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kan J, Zhang JJ, Sheiban I, Santoso T, Munawar M, Tresukosol D, Xu K, Stone GW, Chen SL; DEFINITION II Investigators. 3-Year Outcomes After 2-Stent With Provisional Stenting for Complex Bifurcation Lesions Defined by DEFINITION Criteria. JACC Cardiovasc Interv. 2022 Jul 11;15(13):1310-1320. doi: 10.1016/j.jcin.2022.05.026.
citation: Zhang JJ, Ye F, Xu K, Kan J, Tao L, Santoso T, Munawar M, Tresukosol D, Li L, Sheiban I, Li F, Tian NL, Rodriguez AE, Paiboon C, Lavarra F, Lu S, Vichairuangthum K, Zeng H, Chen L, Zhang R, Ding S, Gao F, Jin Z, Hong L, Ma L, Wen S, Wu X, Yang S, Yin WH, Zhang J, Wang Y, Zheng Y, Zhou L, Zhou L, Zhu Y, Xu T, Wang X, Qu H, Tian Y, Lin S, Liu L, Lu Q, Li Q, Li B, Jiang Q, Han L, Gan G, Yu M, Pan D, Shang Z, Zhao Y, Liu Z, Yuan Y, Chen C, Stone GW, Han Y, Chen SL. Multicentre, randomized comparison of two-stent and provisional stenting techniques in patients with complex coronary bifurcation lesions: the DEFINITION II trial. Eur Heart J. 2020 Jul 14;41(27):2523-2536. doi: 10.1093/eurheartj/ehaa543.
citation: Zhang JJ, Gao XF, Han YL, Kan J, Tao L, Ge Z, Tresukosol D, Lu S, Ma LK, Li F, Yang S, Zhang J, Munawar M, Li L, Zhang RY, Zeng HS, Santoso T, Xie P, Jin ZN, Han L, Yin WH, Qian XS, Li QH, Hong L, Paiboon C, Wang Y, Liu LJ, Zhou L, Wu XM, Wen SY, Lu QH, Yuan JQ, Chen LL, Lavarra F, Rodriguez AE, Zhou LM, Ding SQ, Vichairuangthum K, Zhu YS, Yu MY, Chen C, Sheiban I, Xia Y, Tian YL, Shang ZL, Jiang Q, Zhen YH, Wang X, Ye F, Tian NL, Lin S, Liu ZZ, Chen SL. Treatment effects of systematic two-stent and provisional stenting techniques in patients with complex coronary bifurcation lesions: rationale and design of a prospective, randomised and multicentre DEFINITION II trial. BMJ Open. 2018 Mar 6;8(3):e020019. doi: 10.1136/bmjopen-2017-020019.