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

NCT ID: NCT02516891

Last Updated: 2016-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 235 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2016-02-29

Brief 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.

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.

Conditions

Coronary Health Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Drug-Eluting Stents implantation in bifurcation lesions

Intervention Type: DEVICE

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Drug-Eluting Stents implantation in bifurcation lesions

Intervention Type: DEVICE

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role: collaborator

Maimónides Biomedical Research Institute of Córdoba

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Universitario Reina Sofía

Córdoba, Córdoba, Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 27659568 (View on PubMed)

Other Identifiers

PI12/00440

Identifier Type: -

Identifier Source: org_study_id