Everolimus-Eluting Stent for Bifurcation Coronary Lesions: Comparison of Simple Versus Complex Techniques

Study Overview
=================
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).

Official Title
-----------------
Everolimus-Eluting Stent in the Treatment of Bifurcation Lesions: Comparison of Main Vessel Stent to Main Vessel and Side Branch Stent

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Device: Xience V Everolimus Eluting Coronary Stent System. Abbott Laboratories. Abbott Park, Illinois, U.S.A.


Participation Criteria
=================
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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Complex PCI strategy for bifurcation coronary lesions<br>Stenting main vessel and T-stenting for the side branch | Device: Xience V Everolimus Eluting Coronary Stent System. Abbott Laboratories. Abbott Park, Illinois, U.S.A.<br>* Complex PCI strategy for bifurcation: After optional pre-dilation of one or both vessels (main and side branch), and subsequent implanting of the stent in the main vessel, the side branch is approached by implanting a new stent as T technique. Simple PCI strategy for bifurcation: After optional pre-dilation of one or both vessels (main and side branch), a stent is deployed at main vessel. Side branch is approached by using provisional T stenting technique.<br>|
| Active Comparator: Simple PCI strategies for bifurcation coronary lesions<br>Stenting main vessel, with provisional stenting for the side branch. | Device: Xience V Everolimus Eluting Coronary Stent System. Abbott Laboratories. Abbott Park, Illinois, U.S.A.<br>* Complex PCI strategy for bifurcation: After optional pre-dilation of one or both vessels (main and side branch), and subsequent implanting of the stent in the main vessel, the side branch is approached by implanting a new stent as T technique. Simple PCI strategy for bifurcation: After optional pre-dilation of one or both vessels (main and side branch), a stent is deployed at main vessel. Side branch is approached by using provisional T stenting technique.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the rate of binary angiographic restenosis (in main vessel and side branch) in the simple versus complex strategy groups |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Combined rate of events (cardiac death, myocardial infarction and TLR) |  | 8 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stents, Angioplasty, Coronary Artery Disease, Bifurcation Coronary Lesions