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

Coronary Angiography Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01090856
• Other study ID #: PI 0209/09
• Status: Completed
• Phase: Phase 4
• First received: March 22, 2010
• Last updated: December 4, 2014
• Start date: February 2009
• Est. completion date: May 2013

Study information

• Verified date: May 2013
• Source: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: May 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Angiography

Intervention

Procedure:
• Pre-dilation side branch
Balloon pre-dilation of the side branch to facilitate the ulterior wire access.

Locations

Country	Name	City	State
Spain	Hospital Universitario Reina Sofía	Córdoba

Sponsors (2)

Lead Sponsor	Collaborator
Fundación Pública Andaluza Progreso y Salud	Hospital Universitario Reina Sofia

Country where clinical trial is conducted

Spain, 

References & Publications (8)

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Side branch coronary flow after main vessels stent implantation		Immediately after catheterization procedure	No
Secondary	Time required for rewiring of the side branch		Inmediately after catheterization procedure	No
Secondary	Number of used wires		Inmediately after catheterization procedure	No
Secondary	Levels of markers of myocardial injury (CK and TpI) after the procedure		Immediately after catheterization procedure	No
Secondary	Related cardiac events at 9 months		Immediately after catheterization procedure	No