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

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ClinicalTrials.gov Identifier: NCT01430377
Recruitment Status : Unknown
Verified September 2011 by Dobrin Vassilev MD, PhD, Medica Cor Heart Hospital.
Recruitment status was:  Recruiting
First Posted : September 8, 2011
Last Update Posted : September 8, 2011
Sponsor:
Information provided by (Responsible Party):
Dobrin Vassilev MD, PhD, 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.

Condition or disease Intervention/treatment Phase
Coronary Ostium Stenosis Myonecrosis Procedure: SB predilatation Procedure: No SB predilatation Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Side Branch Predilatation Strategy in Coronary Bifurcation Lesion Stenting (SBPS)
Study Start Date : August 2011
Estimated Primary Completion Date : April 2012
Estimated Study Completion Date : May 2012

Arm Intervention/treatment
Experimental: SB predilatation Procedure: SB predilatation
Initial SB [predilatation.
Procedure: No SB predilatation
Without SB predilatation



Primary Outcome Measures :
  1. Time for rewiring SB [ Time Frame: 24h ]

Secondary Outcome Measures :
  1. Periprocedural myonecrosis [ Time Frame: 24 h ]
  2. MACE [ Time Frame: 12 months ]
    death, MI, TVR



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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dobrin Vassilev MD, PhD, Medica Cor Heart Hospital
ClinicalTrials.gov Identifier: NCT01430377     History of Changes
Other Study ID Numbers: SBPS
First Posted: September 8, 2011    Key Record Dates
Last Update Posted: September 8, 2011
Last Verified: September 2011

Keywords provided by Dobrin Vassilev MD, PhD, Medica Cor Heart Hospital:
periprocedural myonecrosis
procedure time
fluoroscopy time