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

F

Fundación Pública Andaluza Progreso y Salud

Status and phase

Completed
Phase 4

Conditions

Coronary Angiography

Treatments

Procedure: Pre-dilation side branch

Study type

Interventional

Funder types

Other

Identifiers

NCT01090856
PI 0209/09

Details and patient eligibility

About

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.

Full 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.

Enrollment

420 patients

Sex

All

Ages

30 to 85 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

420 participants in 2 patient groups

No pre-dilation side branch
No Intervention group
Pre-dilation side branch
Active Comparator group
Treatment:
Procedure: Pre-dilation side branch

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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