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

Nanjing Medical University

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Procedure: Percutaneous coronary intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02284750

NFH20141029

Details and patient eligibility

About

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

Full 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.

Enrollment: 660 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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660 participants in 2 patient groups

Two-stenting technique

Experimental group

Description:

Percutaneous coronary intervention with DK crush, or culotte technique

Treatment:

Procedure: Percutaneous coronary intervention

Provisional stenting technique

Active Comparator group

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.

Treatment:

Procedure: Percutaneous coronary intervention