Predilation of Side Branch During Percutaneous Treatment of Bifurcation Lesions With Provisional T Stenting
Condition: Coronary Angiography
Study type: Interventional
Phase: Phase 4

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.
    

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.
    

Intervention name(s): Pre-dilation side branch
Intervention type(s): Procedure
Intervention description(s): Balloon pre-dilation of the side branch to facilitate the ulterior wire access.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bifurcations; Drug eluting-stents; Provisional stenting