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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Spanish Society of Cardiology.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Spanish Society of Cardiology
ClinicalTrials.gov Identifier:
NCT00916695
First received: June 1, 2009
Last updated: July 22, 2009
Last verified: July 2009
  Purpose

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).


Condition Intervention Phase
Coronary Artery Disease
Device: Xience V Everolimus Eluting Coronary Stent System. Abbott Laboratories. Abbott Park, Illinois, U.S.A.
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Everolimus-Eluting Stent in the Treatment of Bifurcation Lesions: Comparison of Main Vessel Stent to Main Vessel and Side Branch Stent

Resource links provided by NLM:


Further study details as provided by Spanish Society of Cardiology:

Primary Outcome Measures:
  • Comparison of the rate of binary angiographic restenosis (in main vessel and side branch) in the simple versus complex strategy groups [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Combined rate of events (cardiac death, myocardial infarction and TLR) [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 332
Study Start Date: June 2009
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Complex PCI strategy for bifurcation coronary lesions
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.

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.

Active Comparator: Simple PCI strategies for bifurcation coronary lesions
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.

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.


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00916695

Contacts
Contact: Rafael J Ruiz-Salmeron, PhD 0034955693440 rjruizsalmeron@yahoo.es

Locations
Spain
Hospital Universitario Virgen Macarena Recruiting
Sevilla, Spain, 41007
Contact: Rafael J Ruiz-Salmeron, PhD    +34955693440    rjruizsalmeron@yahoo.es   
University Hospital Virgen Macarena Not yet recruiting
Seville, Spain, 41007
Contact: Rafael j Ruiz-Salmeron, PhD    0034955693449    rjruizsalmeron@yahoo.es   
Principal Investigator: Rafael J Ruiz-Salmeron, Phd         
Sub-Investigator: Manuel Vizcaino, PhD         
Sub-Investigator: Sergio Rodriguez-Leiras, MD         
Sub-Investigator: Cesar Carrascosa, MD         
Sub-Investigator: Francisco Marcos, PhD         
Sponsors and Collaborators
Spanish Society of Cardiology
Investigators
Principal Investigator: Federico Gimeno, MD Hospital Clinico Universitario Valladolid
Principal Investigator: Bruno Garcia, MD Hospital Valle de Hebron. Barcelona
Principal Investigator: Ramiro Trillo, MD Hospital Clínico Santiago
Principal Investigator: Jose Moreu, MD Hospital Virgen de la Salud, Toledo
Principal Investigator: Javier Goicolea, MD Hospital Puerta de Hierro. Madrid
Principal Investigator: Raul Moreno, MD Hospital La Paz (Madrid)
Principal Investigator: Jose F Diaz, MD Hospital Juan Ramon Jimenez. Huelva
Principal Investigator: Jose M Hernandez, MD Hospital Clinico de Malaga
Principal Investigator: Ramon Lopez-Palop, MD Hospital San Juan. Alicante
Principal Investigator: Mariano Valdes, MD Hospital Virgen de la Arrixaca, Murcia
Principal Investigator: Pascual Bordes, MD Hospital Universitario. Alicante
Principal Investigator: Jose R Rumoroso, MD Hospital Galdakao. Vizcaya
  More Information

No publications provided

Responsible Party: Fernando Martín Burrieza, Spanish Society of Cardiology
ClinicalTrials.gov Identifier: NCT00916695     History of Changes
Other Study ID Numbers: XV02RS, XV02RS
Study First Received: June 1, 2009
Last Updated: July 22, 2009
Health Authority: Spain: Ministry of Health

Keywords provided by Spanish Society of Cardiology:
Stents
Angioplasty
Coronary Artery Disease
Bifurcation Coronary Lesions

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases
Everolimus
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014