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

This study has been completed.
Sponsor:
Collaborator:
Hospital Universitario Reina Sofia
Information provided by (Responsible Party):
Fundación Pública Andaluza Progreso y Salud
ClinicalTrials.gov Identifier:
NCT01090856
First received: March 22, 2010
Last updated: May 7, 2013
Last verified: May 2013
  Purpose

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 Intervention Phase
Coronary Angiography
Procedure: Pre-dilation side branch
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Predilation of Side Branch During Percutaneous Treatment of Bifurcation Lesions With Provisional T Stenting.

Further study details as provided by Fundación Pública Andaluza Progreso y Salud:

Primary Outcome Measures:
  • Side branch coronary flow after main vessels stent implantation [ Time Frame: Immediately after catheterization procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time required for rewiring of the side branch [ Time Frame: Inmediately after catheterization procedure ] [ Designated as safety issue: No ]
  • Number of used wires [ Time Frame: Inmediately after catheterization procedure ] [ Designated as safety issue: No ]
  • Levels of markers of myocardial injury (CK and TpI) after the procedure [ Time Frame: Immediately after catheterization procedure ] [ Designated as safety issue: No ]
  • Related cardiac events at 9 months [ Time Frame: Immediately after catheterization procedure ] [ Designated as safety issue: No ]

Enrollment: 420
Study Start Date: February 2009
Study Completion Date: May 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

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.
  Eligibility

Ages Eligible for Study:   30 Years to 85 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01090856

Locations
Spain
Hospital Universitario Reina Sofía
Córdoba, Spain, 14004
Sponsors and Collaborators
Fundación Pública Andaluza Progreso y Salud
Hospital Universitario Reina Sofia
Investigators
Principal Investigator: Manuel Pan Alvarez-Osorio, MD Hospital Universitario Reina Sofia
  More Information

Publications:

Responsible Party: Fundación Pública Andaluza Progreso y Salud
ClinicalTrials.gov Identifier: NCT01090856     History of Changes
Other Study ID Numbers: PI 0209/09
Study First Received: March 22, 2010
Last Updated: May 7, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Fundación Pública Andaluza Progreso y Salud:
Bifurcations
Drug eluting-stents
Provisional stenting

ClinicalTrials.gov processed this record on August 27, 2014