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

This study is currently recruiting participants.
Verified September 2011 by Medica Cor Heart Hospital
Sponsor:
Information provided by (Responsible Party):
Dobrin Vassilev MD, PhD, Medica Cor Heart Hospital
ClinicalTrials.gov Identifier:
NCT01430377
First received: September 3, 2011
Last updated: September 7, 2011
Last verified: September 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Coronary Ostium Stenosis
Myonecrosis
 Procedure: SB predilatation
Procedure: No SB predilatation
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Side Branch Predilatation Strategy in Coronary Bifurcation Lesion Stenting (SBPS)

Further study details as provided by Medica Cor Heart Hospital:

Primary Outcome Measures:
  • Time for rewiring SB [ Time Frame: 24h ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Periprocedural myonecrosis [ Time Frame: 24 h ] [ Designated as safety issue: Yes ]
  • MACE [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    death, MI, TVR


Estimated Enrollment: 120
Study Start Date: August 2011
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SB predilatation Procedure: SB predilatation
Initial SB [predilatation.
Procedure: No SB predilatation
Without SB predilatation

  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01430377

Contacts
Contact: Dobrin I Vassilev, MD, PhD 00359886846550 dobrinv@gmail.com

Locations
Bulgaria
Medica Cor Heart Hospital Recruiting
Ruse, Bulgaria, 7000
Contact: Dobrin I Vassilev, MD, PhD     00359886846550     dobrinv@gmail.com    
Contact: Hristo Popov, MD     00359887686003     hrpopov@gmail.com    
Sponsors and Collaborators
Medica Cor Heart Hospital
  More Information

No publications provided

Responsible Party: Dobrin Vassilev MD, PhD, Medica Cor Heart Hospital
ClinicalTrials.gov Identifier: NCT01430377     History of Changes
Other Study ID Numbers: SBPS
Study First Received: September 3, 2011
Last Updated: September 7, 2011
Health Authority: Bulgaria: Ethics commettee

Keywords provided by Medica Cor Heart Hospital:
periprocedural myonecrosis
procedure time
fluoroscopy time

ClinicalTrials.gov processed this record on June 17, 2013