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Two-stent vs Provisional Stenting Techniques for Patients With Complex Coronary Bifurcation Lesions (DEFINITION-II)

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Percutaneous coronary intervention
Sponsored by
Nanjing First Hospital, Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Bifurcation lesion, Percutaneous coronary intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nanjing First Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Two-stenting technique

Provisional stenting technique

Arm Description

Percutaneous coronary intervention with DK crush, or culotte 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Cardiac death
Target-vessel myocardial infarction
Target lesion revascularisation
Target vessel revascularisation
Stent thrombosis

Full Information

First Posted
October 29, 2014
Last Updated
December 12, 2019
Sponsor
Nanjing First Hospital, Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02284750
Brief Title
Two-stent vs Provisional Stenting Techniques for Patients With Complex Coronary Bifurcation Lesions
Acronym
DEFINITION-II
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

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
December 2015 (Actual)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing First Hospital, Nanjing Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Bifurcation lesion, Percutaneous coronary intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
660 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Two-stenting technique
Arm Type
Experimental
Arm Description
Percutaneous coronary intervention with DK crush, or culotte technique
Arm Title
Provisional stenting technique
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Percutaneous coronary intervention
Other Intervention Name(s)
PCI
Primary Outcome Measure Information:
Title
Target lesion failure
Description
Combined end point of: cardiac death, target-vessel myocardial infarction (MI), or target lesion revascularization (TLR).
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Cardiac death
Time Frame
12 months
Title
Target-vessel myocardial infarction
Time Frame
12 months
Title
Target lesion revascularisation
Time Frame
12 months
Title
Target vessel revascularisation
Time Frame
12 months
Title
Stent thrombosis
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Acute gain
Description
The acute gain was defined as the difference between post- and preprocedural minimal lumen diameter (MLD)
Time Frame
Intraoperative
Title
In-stent restenosis
Description
In-stent restenosis was defined as ≥50% diameter stenosis at the follow-up angiogram.
Time Frame
13 months
Title
Late lumen loss
Description
The late lumen loss was defined as the difference between post- and follow-up minimal lumen diameter (MLD)
Time Frame
13 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shao-Liang Chen, MD
Organizational Affiliation
Nanjing First Hospital, Nanjing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nanjing First Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210006
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35798473
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.
Results Reference
derived
PubMed Identifier
32588060
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.
Results Reference
derived
PubMed Identifier
29511018
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. Erratum In: BMJ Open. 2018 Dec 4;8(12):e020019corr1.
Results Reference
derived

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

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