Predilation of Side Branch During Percutaneous Treatment of Bifurcation Lesions With Provisional T Stenting

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ClinicalTrials.gov Identifier: NCT01090856

Recruitment Status : Completed

First Posted : March 23, 2010

Last Update Posted : December 5, 2014

Sponsor:

Collaborator:

Hospital Universitario Reina Sofia de Cordoba

Information provided by (Responsible Party):

Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud ( Fundación Pública Andaluza Progreso y Salud )

Study Description

Brief Summary:

Percutaneous treatment of bifurcation lesion is a complex procedure. After main vessel stent implantation, the side branch became jailed and the carina can be displaced resulting in complete occlusion of this vessel. Re-wiring the side branch in this conditions may result difficult and some times impossible. There is no agreement regarding the need of side branch pre-dilation (before main vessel stent implantation) to reduce these complications. Researchers from European Bifurcation Club have proposed no to pre-dilate the side branch to avoid vessel dissection and difficulties in rewiring the true lumen of the vessel. On the contrary, our group has a good experience in the treatment of bifurcation lesions treated with side branch pre-dilation.

Aims: 1.- To determine the efficacy of the side-branch pre-dilation in patients with bifurcations lesions treated with provisional T stenting. 2.- To determine the success rate and incidence of complications in patients with and without side-branch pre-dilation, as well as economic impact in terms of number of used wires.

Condition or disease	Intervention/treatment	Phase
Coronary Angiography	Procedure: Pre-dilation side branch	Phase 4

Detailed Description:

Introduction: Percutaneous treatment of bifurcation lesion is a complex procedure. After main vessel stent implantation, the side branch became jailed and the carina can be displaced resulting in complete occlusion of this vessel. Re-wiring the side branch in this conditions may result difficult and some times impossible. There is no agreement regarding the need of side branch pre-dilation (before main vessel stent implantation) to reduce these complications. Researchers from European Bifurcation Club have proposed no to pre-dilate the side branch to avoid vessel dissection and difficulties in rewiring the true lumen of the vessel. On the contrary, our group has a good experience in the treatment of bifurcation lesions treated with side branch pre-dilation.

Design: Prospective and randomized study. Patients and methods: The series is constituted by 420 patients with bifurcations lesions that will be treated with drug-eluting stents; 210 patients will be treated with side branch pre-dilation before main vessels stent implantation, while the remaining 210 patients will be randomized to no pre-dilation of the side-branch.

Primary end point:

TIMI flow at Side Branch after main vessel stent implantation.

Secondary end points:

Time of re-wiring.
Number of used wires.
% of stenosis at Side Branch.
Levels of CK and TpI after the procedure.
Related cardiac events at 9 months. Relevance: Currently there has been controversy over the use of the side branch pre-dilation in patients with bifurcations lesions treated with provisional T-stenting. However, we have no comparative study in the literature.

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	420 participants
Allocation:	Randomized
Intervention Model:	Factorial Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Predilation of Side Branch During Percutaneous Treatment of Bifurcation Lesions With Provisional T Stenting.
Study Start Date :	February 2009
Actual Primary Completion Date :	November 2012
Actual Study Completion Date :	May 2013

Arms and Interventions

Arm	Intervention/treatment
No Intervention: No pre-dilation side branch
Active Comparator: Pre-dilation side branch	Procedure: Pre-dilation side branch Balloon pre-dilation of the side branch to facilitate the ulterior wire access.

Outcome Measures

Primary Outcome Measures :

Side branch coronary flow after main vessels stent implantation [ Time Frame: Immediately after catheterization procedure ]

Secondary Outcome Measures :

Time required for rewiring of the side branch [ Time Frame: Inmediately after catheterization procedure ]
Number of used wires [ Time Frame: Inmediately after catheterization procedure ]
Levels of markers of myocardial injury (CK and TpI) after the procedure [ Time Frame: Immediately after catheterization procedure ]
Related cardiac events at 9 months [ Time Frame: Immediately after catheterization procedure ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	30 Years to 85 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with atherosclerotic coronary disease and bifurcation lesions an significant stenosis of the side branch.
Main vessels diameter greater than 2.5 mm in diameter at the operator's visual estimate.
The side branch should exceed 2.25 mm in diameter at the operator's visual estimate.
Patients with damage to the main branch of any length and the side branch lesions smaller than 5 mm in length.
Patients with bifurcation lesions fulfilling the following morphologies of the classification of Medina: 1 1 1, 1 0 1, 0 1 1.
Treatment of bifurcation lesions with previsional drug eluting stents.
Symptoms of stable angina or acute coronary syndrome.

Exclusion Criteria:

Contraindication to drug eluting stent implantation.
Cardiogenic shock.
Coexistence of other serious systemic diseases.
Patients in whom it is impossible to guide placement in the side branch before stent implantation in the main vessel.
Patients with bifurcation lesions and side branch less than 2 mm.

Contacts and Locations

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): NCT01090856

Locations


Spain
Hospital Universitario Reina Sofía
Córdoba, Spain, 14004

Sponsors and Collaborators

Fundación Pública Andaluza Progreso y Salud

Hospital Universitario Reina Sofia de Cordoba

Investigators


Principal Investigator:	Manuel Pan Alvarez-Osorio, MD	Hospital Universitario Reina Sofia de Cordoba

More Information

Publications:

Pan M, Medina A, Suárez de Lezo J, Romero M, Melián F, Pavlovic D, Hernández E, Segura J, Marrero J, Torres F, et al. Follow-up patency of side branches covered by intracoronary Palmaz-Schatz stent. Am Heart J. 1995 Mar;129(3):436-40.

Pan M, Suárez de Lezo J, Medina A, Romero M, Hernández E, Segura J, Castroviejo JR, Pavlovic D, Melian F, Ramírez A, Castillo JC. Simple and complex stent strategies for bifurcated coronary arterial stenosis involving the side branch origin. Am J Cardiol. 1999 May 1;83(9):1320-5.

Pan M, Suárez de Lezo J, Medina A, Romero M, Segura J, Ramírez A, Pavlovic D, Hernández E, Ojeda S, Adamuz C. A stepwise strategy for the stent treatment of bifurcated coronary lesions. Catheter Cardiovasc Interv. 2002 Jan;55(1):50-7.

Pan M, de Lezo JS, Medina A, Romero M, Segura J, Pavlovic D, Delgado A, Ojeda S, Melián F, Herrador J, Ureña I, Burgos L. Rapamycin-eluting stents for the treatment of bifurcated coronary lesions: a randomized comparison of a simple versus complex strategy. Am Heart J. 2004 Nov;148(5):857-64.

Pan M, Suárez de Lezo J, Medina A, Romero M, Delgado A, Segura J, Ojeda S, Pavlovic D, Ariza J, Fernández-Dueñas J, Herrador J, Ureña I. [Six-month intravascular ultrasound follow-up of coronary bifurcation lesions treated with rapamycin-eluting stents: technical considerations]. Rev Esp Cardiol. 2005 Nov;58(11):1278-86. Spanish.

de Lezo JS, Medina A, Pan M, Delgado A, Segura J, Pavlovic D, Melián F, Romero M, Burgos L, Hernández E, Ureña I, Herrador J. Rapamycin-eluting stents for the treatment of unprotected left main coronary disease. Am Heart J. 2004 Sep;148(3):481-5.

Medina A, Suárez de Lezo J, Pan M. [A new classification of coronary bifurcation lesions]. Rev Esp Cardiol. 2006 Feb;59(2):183. Spanish.

Pan M, Suárez de Lezo J, Medina A, Romero M, Delgado A, Segura J, Ojeda S, Mazuelos F, Hernandez E, Melian F, Pavlovic D, Esteban F, Herrador J. Drug-eluting stents for the treatment of bifurcation lesions: a randomized comparison between paclitaxel and sirolimus stents. Am Heart J. 2007 Jan;153(1):15.e1-7.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Pan M, Medina A, Romero M, Ojeda S, Martin P, Suarez de Lezo J, Segura J, Mazuelos F, Novoa J, Suarez de Lezo J. Assessment of side branch predilation before a provisional T-stent strategy for bifurcation lesions. A randomized trial. Am Heart J. 2014 Sep;168(3):374-80. doi: 10.1016/j.ahj.2014.05.014. Epub 2014 Jun 6.


Responsible Party:	Fundación Pública Andaluza Progreso y Salud
ClinicalTrials.gov Identifier:	NCT01090856 History of Changes
Other Study ID Numbers:	PI 0209/09
First Posted:	March 23, 2010 Key Record Dates
Last Update Posted:	December 5, 2014
Last Verified:	May 2013

Keywords provided by Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud ( Fundación Pública Andaluza Progreso y Salud ):


Bifurcations Drug eluting-stents Provisional stenting

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