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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02516891
Enrollment
235
Registered
2015-08-06
Start date
2012-02-29
Completion date
2016-02-29
Last updated
2016-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Health Disease

Keywords

treatment, stent, coronary bifurcations lesions

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.

Interventions

DEVICEDrug-Eluting Stents implantation in bifurcation lesions

Sponsors

Instituto de Salud Carlos III
CollaboratorOTHER_GOV
Maimónides Biomedical Research Institute of Córdoba
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
No damage: the guidewire suffered no loss of integrity over its entire length3 years
Slight damage: the external cover suffered loss of integrity < 2 mm3 years
Moderate damage: the external cover suffered loss of integrity > 2 mm3 years
Severe damage: visible changes to the inner cover of the guidewire.3 years
Fracture: discontinuity at some point along the guidewire3 years

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026