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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00916695

Enrollment

332

Registered

2009-06-09

Start date

2009-06-30

Completion date

2011-02-28

Last updated

2009-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

Stents, Angioplasty, Coronary Artery Disease, Bifurcation Coronary Lesions

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).

Interventions

DEVICEXience V Everolimus Eluting Coronary Stent System. Abbott Laboratories. Abbott Park, Illinois, U.S.A.

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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).

Design outcomes

Primary

Measure	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

Measure	Time frame
Combined rate of events (cardiac death, myocardial infarction and TLR)	8 months

Countries

Spain

Contacts

Primary ContactRafael J Ruiz-Salmeron, PhD

rjruizsalmeron@yahoo.es0034955693440

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026