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

This study is currently recruiting participants.
Verified June 2017 by Shaoliang Chen, Nanjing First Hospital, Nanjing Medical University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02284750
First Posted: November 6, 2014
Last Update Posted: June 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Shaoliang Chen, Nanjing First Hospital, Nanjing Medical University
  Purpose
The purpose of this study is to establish the optimal strategy for stenting in coronary bifurcation lesion.

Condition Intervention
Coronary Artery Disease Procedure: Percutaneous coronary intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Multi-center, Randomized Trial Comparing Two-stent With Provisional Stenting Techniques for Patients With Complex Coronary Bifurcation Lesions

Further study details as provided by Shaoliang Chen, Nanjing First Hospital, Nanjing Medical University:

Primary Outcome Measures:
  • Target lesion failure [ Time Frame: 12 months ]
    Combined end point of: cardiac death, target-vessel myocardial infarction (MI), or target lesion revascularization (TLR).


Secondary Outcome Measures:
  • Cardiac death [ Time Frame: 12 months ]
  • Target-vessel myocardial infarction [ Time Frame: 12 months ]
  • Target lesion revascularisation [ Time Frame: 12 months ]
  • Target vessel revascularisation [ Time Frame: 12 months ]
  • Stent thrombosis [ Time Frame: 12 months ]

Other Outcome Measures:
  • Acute gain [ Time Frame: Intraoperative ]
    The acute gain was defined as the difference between post- and preprocedural minimal lumen diameter (MLD)

  • In-stent restenosis [ Time Frame: 13 months ]
    In-stent restenosis was defined as ≥50% diameter stenosis at the follow-up angiogram.

  • Late lumen loss [ Time Frame: 13 months ]
    The late lumen loss was defined as the difference between post- and follow-up minimal lumen diameter (MLD)


Estimated Enrollment: 660
Study Start Date: December 2015
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Two-stenting technique
Percutaneous coronary intervention with DK crush, or culotte technique
Procedure: Percutaneous coronary intervention
Other Name: PCI
Active Comparator: 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.
Procedure: Percutaneous coronary intervention
Other Name: PCI

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 25% after PCI with provisional stenting. And our previous data showed that this event at 12-month after DK crush procedure was 15%. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02284750


Contacts
Contact: Shao-Liang Chen Chen, MD +86-25-52208351 chmengx@126.com
Contact: Jing Kan, MBBS +86-25-52208391 kanjingok@126.com

Locations
China, Jiangsu
Nanjing First Hospital Recruiting
Nanjing, Jiangsu, China, 210006
Contact: Shaoliang Chen, MD    +86 13605157029    chmengx@126.com   
Sponsors and Collaborators
Nanjing First Hospital, Nanjing Medical University
Investigators
Principal Investigator: Shao-Liang Chen, MD Nanjing First Hospital, Nanjing Medical University
  More Information

Responsible Party: Shaoliang Chen, Vice President, Nanjing First Hospital, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT02284750     History of Changes
Other Study ID Numbers: NFH20141029
First Submitted: October 29, 2014
First Posted: November 6, 2014
Last Update Posted: June 6, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Shaoliang Chen, Nanjing First Hospital, Nanjing Medical University:
Bifurcation lesion
Percutaneous coronary intervention

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases