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Two-stent vs Provisional Stenting Techniques for Patients With Complex Coronary Bifurcation Lesions

NCT ID: NCT02284750

Last Updated: 2019-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

660 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2019-12-31

Brief Summary

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The purpose of this study is to establish the optimal strategy for stenting in coronary bifurcation lesion.

Detailed Description

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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.

Conditions

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Coronary Artery Disease

Keywords

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Bifurcation lesion Percutaneous coronary intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Two-stenting technique

Percutaneous coronary intervention with DK crush, or culotte technique

Group Type EXPERIMENTAL

Percutaneous coronary intervention

Intervention Type PROCEDURE

Provisional stenting technique

Percutaneous coronary intervention with Provisional stenting technique. Stenting of the side branch was required if TIMI flow was \<3, or ≥ type B dissection after kissing balloon inflation.

Group Type ACTIVE_COMPARATOR

Percutaneous coronary intervention

Intervention Type PROCEDURE

Interventions

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Percutaneous coronary intervention

Intervention Type PROCEDURE

Other Intervention Names

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PCI

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Shaoliang Chen

Vice President

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shao-Liang Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Nanjing First Hospital, Nanjing Medical University

Locations

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Nanjing First Hospital

Nanjing, Jiangsu, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 35798473 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32588060 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29511018 (View on PubMed)

Other Identifiers

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NFH20141029

Identifier Type: -

Identifier Source: org_study_id