NCT02284750

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
660

participants targeted

Target at P75+ for not_applicable coronary-artery-disease

Timeline
Completed

Started Dec 2015

Typical duration for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 6, 2014

Completed
1.1 years until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

December 16, 2019

Status Verified

December 1, 2019

Enrollment Period

4 years

First QC Date

October 29, 2014

Last Update Submit

December 12, 2019

Conditions

Coronary Artery Disease

Keywords

Bifurcation lesionPercutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

  • Target lesion failure

    Combined end point of: cardiac death, target-vessel myocardial infarction (MI), or target lesion revascularization (TLR).

    12 months

Secondary Outcomes (5)

  • Cardiac death

    12 months

  • Target-vessel myocardial infarction

    12 months

  • Target lesion revascularisation

    12 months

  • Target vessel revascularisation

    12 months

  • Stent thrombosis

    12 months

Other Outcomes (3)

  • Acute gain

    Intraoperative

  • In-stent restenosis

    13 months

  • Late lumen loss

    13 months

Study Arms (2)

Two-stenting technique

EXPERIMENTAL

Percutaneous coronary intervention with DK crush, or culotte technique

Procedure: Percutaneous coronary intervention

Provisional stenting technique

ACTIVE COMPARATOR

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.

Procedure: Percutaneous coronary intervention

Interventions

Percutaneous coronary interventionPROCEDURE
Also known as: PCI
Provisional stenting techniqueTwo-stenting technique

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

Location

Related Publications (3)

  • 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.

    PMID: 35798473DERIVED

  • 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.

    PMID: 32588060DERIVED

  • 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.

    PMID: 29511018DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Shao-Liang Chen, MD

    Nanjing First Hospital, Nanjing Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice President

Study Record Dates

First Submitted

October 29, 2014

First Posted

November 6, 2014

Study Start

December 1, 2015

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

December 16, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)