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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hydrophilic wire/Drug-Eluting Stents | Experimental | 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 wire/Drug-Eluting Stents | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug-Eluting Stents implantation in bifurcation lesions | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Reina Sofía | Córdoba | Córdoba | 14004 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27659568 | Derived | 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. |
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