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

Coronary Health Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02516891
• Other study ID #: PI12/00440
• Status: Completed
• Phase: Phase 4
• First received: July 23, 2014
• Last updated: April 5, 2016
• Start date: February 2012
• Est. completion date: February 2016

Study information

• Verified date: April 2016
• Source: Maimónides Biomedical Research Institute of Córdoba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 235
• Est. completion date: February 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Coronary Health Disease

Intervention

Device:
• Drug-Eluting Stents implantation in bifurcation lesions

Locations

Country	Name	City	State
Spain	Hospital Universitario Reina Sofía	Córdoba

Sponsors (2)

Lead Sponsor	Collaborator
Maimónides Biomedical Research Institute of Córdoba	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

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