Jailed Wire Technique in the Treatment of Coronary Bifurcations Lesions With Stent: Stereoscopic Microscopy Study

Jailed Wire Technique in the Treatment of Coronary Bifurcations Lesions With Stent: Prospective Randomized Study With Stereoscopic Microscopy

The aims of this study are: 1) To identify more resistant the guidewire type to the retrieval maneuvers after the jailing.

2) To determined anatomic and technical factors influencing the induced damage in the guidewire.

Design of the study: prospective randomized study to compare 2 types of guidewire: hydrophilic and no hydrophilic. Patients and methods: Two hundred patients with bifurcation coronary lesions will be included. All of then will be treated by provisional side-branch stenting using the jailed wire technique. One hundred patients will be randomized to hydrophilic wires and another 100 patients to non-hydrophilic wires.

Study Overview

• Status: Completed
• Conditions: Coronary Health Disease
• Intervention / Treatment: Device: Drug-Eluting Stents implantation in bifurcation lesions

Detailed Description

The percutaneous approach of bifurcation lesions is a complex procedure; when the stent is implanted at main vessel, a closure of the side-branch may occur. The re-wiring of the side-branch in these conditions may be difficult or even impossible. To facilitate the re-wiring maneuvers the operators use the jailed wired technique. For this technique a guide-wire is introduced in the side-branch before main vessel stent implantation; after the stent deployment the wire remains jailed between the vessel wall and the metallic structure of the stent. If the side-branch became occluded, this wire is a good landmark of it is position, facilitating the access with a new wire. However, the rupture of the wire has been described in some cases, during the retrieval maneuvers.

• Study Type: Interventional
• Enrollment (Actual): 235
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Córdoba, Spain, 14004
    • Hospital Universitario Reina Sofía

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with atherosclerotic coronary disease and bifurcation lesions requiring protection with side branch.
• The art of imprisoned guide.
• The main branch should be greater than 2.5 mm in diameter at the operator's visual estimate.
• The side branch must exceed 2 mm in diameter or have sufficient authority to protect the operator decides with a guide for the release of the main vessel stent.
• Patients with the above characteristics and main or side branch of any length.
• Patients with bifurcation lesions with any morphology of the Medina classification: 1 1 1 1 0 1 0 1 1, 110, 001, 010, 100.
• Treatment of bifurcation with any technique and any type of stent in the side branch meets the criteria above.
• Symptoms of stable angina or acute coronary syndrome.

Exclusion Criteria:

• Patients with collateral bouquet of little significance.
• Patients in cardiogenic shock.
• Patients in whom it is impossible to guide the placement of the side branch before implantation in the glass principal.
• Patients who do not give their consent for the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: hydrophilic wire/Drug-Eluting Stents; Will include 100 patients with coronary bifurcation lesions in that they will be treated with stents and in which the technique is used jailed guide.	Device: Drug-Eluting Stents implantation in bifurcation lesions
No Intervention: Non hydrophilic wire/Drug-Eluting Stents; Will include 100 patients with coronary bifurcation lesions in that they will be treated with stents and in which the technique is used jailed guide.non hydrophilic guide.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
No damage: the guidewire suffered no loss of integrity over its entire length	3 years
Slight damage: the external cover suffered loss of integrity < 2 mm	3 years
Moderate damage: the external cover suffered loss of integrity > 2 mm	3 years
Severe damage: visible changes to the inner cover of the guidewire.	3 years
Fracture: discontinuity at some point along the guidewire	3 years

Collaborators and Investigators

• Sponsor: Maimónides Biomedical Research Institute of Córdoba
• Collaborators: Instituto de Salud Carlos III

Publications and helpful links

General Publications

• Pan M, Ojeda S, Villanueva E, Chavarria J, Romero M, Suarez de Lezo J, Mazuelos F, Segura J, Carrasco F, Hidalgo F, Lopez Aguilera J, Rodriguez S, Puente M, Suarez de Lezo J. Structural Damage of Jailed Guidewire During the Treatment of Coronary Bifurcation Lesions: A Microscopic Randomized Trial. JACC Cardiovasc Interv. 2016 Sep 26;9(18):1917-24. doi: 10.1016/j.jcin.2016.06.030.

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: July 23, 2014
• First Submitted That Met QC Criteria: August 5, 2015
• First Posted (Estimate): August 6, 2015

Study Record Updates

• Last Update Posted (Estimate): April 6, 2016
• Last Update Submitted That Met QC Criteria: April 5, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: treatment; stent; coronary bifurcations lesions
• Other Study ID Numbers: PI12/00440