NCT02516891

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 235 (actual)
• Sponsor: Maimónides Biomedical Research Institute of Córdoba · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Drug-Eluting Stents implantation in bifurcation lesions

Timeline

• Start date: 2012-02-01
• Primary completion: 2015-06-01
• Completion: 2016-02-01
• First posted: 2015-08-06
• Last updated: 2016-04-06

Locations

1 site across 1 country: Spain