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

Phase 4

• Conditions: Coronary Ostium Stenosis; Myonecrosis
• Interventions: Procedure: SB predilatation; Procedure: No SB predilatation

• Registration Number: NCT01430377
• Lead Sponsor: Medica Cor Heart Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Status Verified: 2011-09
• Study First Submitted: 2011-09-03
• Study First Submitted QC: 2011-09-07
• Last Update Submitted: 2011-09-07
• Study First Posted: 2011-09-08
• Last Update Posted: 2011-09-08
• Primary Completion: 2012-04
• Study Completion: 2012-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SB predilatation	SB predilatation	-
SB predilatation	No SB predilatation	-

Primary Outcome Measures

Name	Time	Method
Time for rewiring SB	24h

Secondary Outcome Measures

Name	Time	Method
MACE	12 months	death, MI, TVR
Periprocedural myonecrosis	24 h

Trial Locations

Locations (1)

Medica Cor Heart Hospital; 🇧🇬 Ruse, Bulgaria