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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00916695
• Other study ID #: XV02RS
• Secondary ID: XV02RS
• Status: Recruiting
• Phase: Phase 4
• First received: June 1, 2009
• Last updated: July 22, 2009
• Start date: June 2009
• Est. completion date: February 2011

Study information

• Verified date: July 2009
• Source: Spanish Society of Cardiology
• Contact: Rafael J Ruiz-Salmeron, PhD
• Phone: 0034955693440
• Email: rjruizsalmeron[@]yahoo.es
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 332
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• Xience 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.

Locations

Country	Name	City	State
Spain	Hospital Universitario Virgen Macarena	Sevilla
Spain	University Hospital Virgen Macarena	Seville

Sponsors (1)

Lead Sponsor	Collaborator
Spanish Society of Cardiology

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the rate of binary angiographic restenosis (in main vessel and side branch) in the simple versus complex strategy groups		9 months	No
Secondary	Combined rate of events (cardiac death, myocardial infarction and TLR)		8 months	Yes