Clinical trial NCT02516891: Jailed Wire Technique in the Treatment of Coronary Bifurcations Lesions With Stent: Stereoscopic Microscopy Study
Official title: Jailed Wire Technique in the Treatment of Coronary Bifurcations Lesions With Stent: Prospective Randomized Study With Stereoscopic Microscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Health Disease
Keywords: treatment
stent
coronary bifurcations lesions
Lead sponsor: Maimónides Biomedical Research Institute of Córdoba
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2015-08-06
Enrollment: 235
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: No damage: the guidewire suffered no loss of integrity over its entire length
timeFrame: 3 years
measure: Slight damage: the external cover suffered loss of integrity < 2 mm
timeFrame: 3 years
measure: Moderate damage: the external cover suffered loss of integrity > 2 mm
timeFrame: 3 years
measure: Severe damage: visible changes to the inner cover of the guidewire.
timeFrame: 3 years
measure: Fracture: discontinuity at some point along the guidewire
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
Study officials:
References:
citation: 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.