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

NCT ID: NCT01430377

Last Updated: 2011-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-05-31

Brief Summary

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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

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Conditions

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Coronary Ostium Stenosis Myonecrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SB predilatation

Group Type EXPERIMENTAL

SB predilatation

Intervention Type PROCEDURE

Initial SB \[predilatation.

No SB predilatation

Intervention Type PROCEDURE

Without SB predilatation

Interventions

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SB predilatation

Initial SB \[predilatation.

Intervention Type PROCEDURE

No SB predilatation

Without SB predilatation

Intervention Type PROCEDURE

Eligibility Criteria

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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.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medica Cor Heart Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dobrin Vassilev MD, PhD

Dobrin Vassilev MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Medica Cor Heart Hospital

Rousse, , Bulgaria

Site Status RECRUITING

Countries

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Bulgaria

Central Contacts

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Dobrin I Vassilev, MD, PhD

Role: CONTACT

00359886846550

Facility Contacts

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Dobrin I Vassilev, MD, PhD

Role: primary

00359886846550

Hristo Popov, MD

Role: backup

00359887686003

Other Identifiers

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SBPS

Identifier Type: -

Identifier Source: org_study_id

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