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

Coronary Artery Disease Clinical Trial

— DEFINITION-II  

Official title:

A Prospective, Multi-center, Randomized Trial Comparing Two-stent With Provisional Stenting Techniques for Patients With Complex Coronary Bifurcation Lesions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02284750
• Other study ID #: NFH20141029
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: December 2019

Study information

• Verified date: December 2019
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 660
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Procedure:
• Percutaneous coronary intervention

Locations

Country	Name	City	State
China	Nanjing First Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Acute gain	The acute gain was defined as the difference between post- and preprocedural minimal lumen diameter (MLD)	Intraoperative
Other	In-stent restenosis	In-stent restenosis was defined as =50% diameter stenosis at the follow-up angiogram.	13 months
Other	Late lumen loss	The late lumen loss was defined as the difference between post- and follow-up minimal lumen diameter (MLD)	13 months
Primary	Target lesion failure	Combined end point of: cardiac death, target-vessel myocardial infarction (MI), or target lesion revascularization (TLR).	12 months
Secondary	Cardiac death		12 months
Secondary	Target-vessel myocardial infarction		12 months
Secondary	Target lesion revascularisation		12 months
Secondary	Target vessel revascularisation		12 months
Secondary	Stent thrombosis		12 months