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

September 7, 2011 updated by: Dobrin Vassilev MD, PhD, Medica Cor Heart Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Ruse, Bulgaria, 7000
        • Recruiting
        • Medica Cor Heart Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SB predilatation
Procedure: SB predilatation
Initial SB [predilatation.
Procedure: No SB predilatation
Without SB predilatation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time for rewiring SB
Time Frame: 24h
24h

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Periprocedural myonecrosis
Time Frame: 24 h
24 h
MACE
Time Frame: 12 months
death, MI, TVR
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medica Cor Heart Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Anticipated)

April 1, 2012

Study Completion (Anticipated)

May 1, 2012

Study Registration Dates

First Submitted

September 3, 2011

First Submitted That Met QC Criteria

September 7, 2011

First Posted (Estimate)

September 8, 2011

Study Record Updates

Last Update Posted (Estimate)

September 8, 2011

Last Update Submitted That Met QC Criteria

September 7, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SBPS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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