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

NCT01090856 | Completed Phase 4

• 1 other identifier: PI 0209/09
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Angiography

Keywords

Bifurcations; Drug eluting-stents; Provisional stenting

Outcome Measures

Primary Outcomes (1)

• Side branch coronary flow after main vessels stent implantation

  Immediately after catheterization procedure

Secondary Outcomes (4)

• Time required for rewiring of the side branch

  Inmediately after catheterization procedure

• Number of used wires

  Inmediately after catheterization procedure

• Levels of markers of myocardial injury (CK and TpI) after the procedure

  Immediately after catheterization procedure

• Related cardiac events at 9 months

  Immediately after catheterization procedure

Study Arms (2)

No pre-dilation side branch

NO INTERVENTION

Pre-dilation side branch

ACTIVE COMPARATOR

Procedure: Pre-dilation side branch

Interventions

Pre-dilation side branch PROCEDURE

Balloon pre-dilation of the side branch to facilitate the ulterior wire access.

Pre-dilation side branch

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Pública Andaluza Progreso y Salud: lead
• Hospital Universitario Reina Sofia de Cordoba: collaborator

Study Sites (1)

Hospital Universitario Reina Sofía

Córdoba, Córdoba, 14004, Spain

Location

Related Publications (9)

• 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.

  PMID: 7872167 BACKGROUND

• 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.

  PMID: 10235088 BACKGROUND

• 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.

  PMID: 11793495 BACKGROUND

• 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.

  PMID: 15523318 BACKGROUND

• 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.

  PMID: 16324581 BACKGROUND

• 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.

  PMID: 15389236 BACKGROUND

• 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.

  PMID: 16540043 BACKGROUND

• 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.

  PMID: 17174630 BACKGROUND

• 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.

  PMID: 25173550 DERIVED

Study Officials

• Manuel Pan Alvarez-Osorio, MD

  Hospital Universitario Reina Sofia de Cordoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2010
• First Posted: March 23, 2010
• Study Start: February 1, 2009
• Primary Completion: November 1, 2012
• Study Completion: May 1, 2013
• Last Updated: December 5, 2014

Record last verified: 2013-05

Locations

ES (1)