Predilation of Side Branch During Percutaneous Treatment of Bifurcation Lesions With Provisional T Stenting
NCT ID: NCT01090856
Last Updated: 2014-12-05
Study Results
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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COMPLETED
PHASE4
420 participants
INTERVENTIONAL
2009-02-28
2013-05-31
Brief Summary
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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.
Detailed Description
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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.
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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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No pre-dilation side branch
No interventions assigned to this group
Pre-dilation side branch
Pre-dilation side branch
Balloon pre-dilation of the side branch to facilitate the ulterior wire access.
Interventions
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Pre-dilation side branch
Balloon pre-dilation of the side branch to facilitate the ulterior wire access.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
30 Years
85 Years
ALL
No
Sponsors
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Hospital Universitario Reina Sofia de Cordoba
OTHER_GOV
Fundación Pública Andaluza Progreso y Salud
OTHER
Responsible Party
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Principal Investigators
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Manuel Pan Alvarez-Osorio, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Reina Sofia de Cordoba
Locations
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Hospital Universitario Reina Sofía
Córdoba, Córdoba, Spain
Countries
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References
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Pan M, Medina A, Suarez de Lezo J, Romero M, Melian F, Pavlovic D, Hernandez 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. doi: 10.1016/0002-8703(95)90264-3.
Pan M, Suarez de Lezo J, Medina A, Romero M, Hernandez E, Segura J, Castroviejo JR, Pavlovic D, Melian F, Ramirez 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. doi: 10.1016/s0002-9149(99)00093-4.
Pan M, Suarez de Lezo J, Medina A, Romero M, Segura J, Ramirez A, Pavlovic D, Hernandez 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. doi: 10.1002/ccd.10057.
Pan M, de Lezo JS, Medina A, Romero M, Segura J, Pavlovic D, Delgado A, Ojeda S, Melian F, Herrador J, Urena 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. doi: 10.1016/j.ahj.2004.05.029.
Pan M, Suarez de Lezo J, Medina A, Romero M, Delgado A, Segura J, Ojeda S, Pavlovic D, Ariza J, Fernandez-Duenas J, Herrador J, Urena 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, Melian F, Romero M, Burgos L, Hernandez E, Urena I, Herrador J. Rapamycin-eluting stents for the treatment of unprotected left main coronary disease. Am Heart J. 2004 Sep;148(3):481-5. doi: 10.1016/j.ahj.2004.03.011.
Medina A, Suarez de Lezo J, Pan M. [A new classification of coronary bifurcation lesions]. Rev Esp Cardiol. 2006 Feb;59(2):183. No abstract available. Spanish.
Pan M, Suarez 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. doi: 10.1016/j.ahj.2006.10.017.
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.
Other Identifiers
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PI 0209/09
Identifier Type: -
Identifier Source: org_study_id