Side Branch Predilatation Strategy in Coronary Bifurcation Lesion Stenting (SBPS)

Medica Cor Heart Hospital

Status and phase: Unknown; Phase 4

Conditions: Coronary Ostium Stenosis; Myonecrosis

Treatments: Procedure: No SB predilatation; Procedure: SB predilatation

Study type: Interventional

Funder types: Other

Identifiers

NCT01430377

SBPS

Details and patient eligibility

About

The role of Side Branch (SB) predilatation during coronary bifurcation lesion percutaneous coronary intervention (PCI) is still not established. The predilatation could potentially damage SB ostium by vessel dissection, making subsequent wiring problematic. However, predilatation could eliminate SB ostial stenosis obviating need for further SB treatment after main vessel stent implantation. The aim of the study is to assess in random fashion the periprocedural myonecrosis, complication rates and time for SB rewiring in groups with and without SB predilatation.

Enrollment: 120 estimated patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

1. Inclusion Criteria

   • Subject at least 18 years of age.
   • Subject able to verbally confirm understandings of risks, benefits of receiving PCI for true bifurcation lesions, and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
   • Target main branch lesion(s) located in a native coronary artery with diameter of ≥ 2.5 mm and ≤ 4.5 mm. Target side branch lesion(s) located in a native coronary artery with diameter of ≥ 2.0 mm.
   • Target lesion(s) amenable for PCI with balloon angioplasty of the side branch.

2. Exclusion Criteria

   • ST-segment elevation myocardial infarction (STEMI)
   • Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
   • Subjects who refuse to give informed consent.
   • Subjects with left ventricle ejection fraction <30%
   • Subjects with moderate or severe degree valvular heart disease or primary cardiomyopathy
   • Contraindications for 12 months double antiplatelet therapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

SB predilatation

Experimental group

Treatment:

Procedure: No SB predilatation

Procedure: SB predilatation