A Phase 4 interventional study of Drug-Eluting Stents implantation in bifurcation lesions in Coronary Health Disease, sponsored by Maimónides Biomedical Research Institute of Córdoba. Completed at 1 site in Spain. Per ClinicalTrials.gov, last updated 2016-04-06.
Sponsored by Maimónides Biomedical Research Institute of Córdoba · Phase 4, Interventional, and Health services research
The aims of this study are: 1) To identify more resistant the guidewire type to the retrieval maneuvers after the jailing.
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.
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.
Maimónides Biomedical Research Institute of Córdoba is the lead sponsor of 78 studies on the registry; 20 are open to participants now.
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Exclusion Criteria:
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
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.
No damage: the guidewire suffered no loss of integrity over its entire length
Time frame: 3 years
Slight damage: the external cover suffered loss of integrity < 2 mm
Time frame: 3 years
Moderate damage: the external cover suffered loss of integrity > 2 mm
Time frame: 3 years
Severe damage: visible changes to the inner cover of the guidewire.
Time frame: 3 years
Fracture: discontinuity at some point along the guidewire
Time frame: 3 years
This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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Maimónides Biomedical Research Institute of Córdoba