Clinical trial NCT00916695: Everolimus-Eluting Stent for Bifurcation Coronary Lesions: Comparison of Simple Versus Complex Techniques
Official title: Everolimus-Eluting Stent in the Treatment of Bifurcation Lesions: Comparison of Main Vessel Stent to Main Vessel and Side Branch Stent
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: Stents
Angioplasty
Coronary Artery Disease
Bifurcation Coronary Lesions
Lead sponsor: Spanish Society of Cardiology
Sponsor class: OTHER
First posted: 2009-06-09
Enrollment: 332
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of the treatment of true bifurcation lesions with the XIENCE V stent using the simple strategy (stent in main vessel and provisional T-stenting in the side branch) compared to the complex strategy (stent in main vessel and T-stenting in the side branch).


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years old.
* True Bifurcation lesion (Medina classification 1-1-1), in at least one main coronary vessel. Diameter of main vessel between 2,5-4mm, and diameter of side branch 2mm or greater.

Exclusion Criteria:

* Significant left main stenosis.
* ST elevation myocardial infarction \< 48 h.
* Thrombus burden target lesion.
* Ejection Fraction \< 30%.
* Severe Renal Insufficiency (creatinine \> 3 mg/dl).

Primary outcomes:
measure: Comparison of the rate of binary angiographic restenosis (in main vessel and side branch) in the simple versus complex strategy groups
timeFrame: 9 months
Secondary outcomes:
measure: Combined rate of events (cardiac death, myocardial infarction and TLR)
timeFrame: 8 months
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Seville
country: Spain
facility: University Hospital Virgen Macarena
Study officials:
affiliation: Hospital Clinico Universitario Valladolid
name: Federico Gimeno, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Valle de Hebron. Barcelona
name: Bruno Garcia, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clínico Santiago
name: Ramiro Trillo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Virgen de la Salud
name: Jose Moreu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Puerta de Hierro, Madrid
name: Javier Goicolea, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario La Paz
name: Raul Moreno, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Juan Ramon Jimenez. Huelva
name: Jose F Diaz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clinico de Malaga
name: Jose M Hernandez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital San Juan. Alicante
name: Ramon Lopez-Palop, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Virgen de la Arrixaca
name: Mariano Valdes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario. Alicante
name: Pascual Bordes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Galdakao. Vizcaya
name: Jose R Rumoroso, MD
role: PRINCIPAL_INVESTIGATOR
References: