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

Sponsor

Maimónides Biomedical Research Institute of Córdoba (Other)

Overall Status

Completed

CT.gov ID

NCT02516891

Collaborator

Instituto de Salud Carlos III (Other)

235

Enrollment

Location

Arms

Duration (Months)

4.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Health Disease	Device: Drug-Eluting Stents implantation in bifurcation lesions	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

235 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Health Services Research

Official Title:

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

Study Start Date :

Feb 1, 2012

Actual Primary Completion Date :

Jun 1, 2015

Actual Study Completion Date :

Feb 1, 2016

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitario Reina Sofía	Córdoba		Spain	14004

Sponsors and Collaborators

Maimónides Biomedical Research Institute of Córdoba
Instituto de Salud Carlos III

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Maimónides Biomedical Research Institute of Córdoba

ClinicalTrials.gov Identifier:

NCT02516891

Other Study ID Numbers:

PI12/00440

First Posted:

Aug 6, 2015

Last Update Posted:

Apr 6, 2016

Last Verified:

Apr 1, 2016

Keywords provided by Maimónides Biomedical Research Institute of Córdoba

treatment

stent

coronary bifurcations lesions

Study Results

No Results Posted as of Apr 6, 2016