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

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Procedure: Percutaneous coronary intervention

• Registration Number: NCT02284750
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

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.

Study Timeline

• Study First Submitted: 2014-10-29
• Study First Submitted QC: 2014-11-04
• Study First Posted: 2014-11-06
• Study Start: 2015-12
• Status Verified: 2019-12
• Primary Completion: 2019-12
• Study Completion: 2019-12
• Last Update Submitted: 2019-12-12
• Last Update Posted: 2019-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 660

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Provisional stenting technique	Percutaneous coronary intervention	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.
Two-stenting technique	Percutaneous coronary intervention	Percutaneous coronary intervention with DK crush, or culotte technique

Primary Outcome Measures

Name	Time	Method
Target lesion failure	12 months	Combined end point of: cardiac death, target-vessel myocardial infarction (MI), or target lesion revascularization (TLR).

Secondary Outcome Measures

Name	Time	Method
Stent thrombosis	12 months
Target-vessel myocardial infarction	12 months
Target vessel revascularisation	12 months
Cardiac death	12 months
Target lesion revascularisation	12 months

Trial Locations

Locations (1)

Nanjing First Hospital; 🇨🇳 Nanjing, Jiangsu, China