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Register of Treatment of Unprotected Left Main Coronary Artery Stenosis in Andalucía (RETRATO)

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ClinicalTrials.gov Identifier: NCT01971749
Recruitment Status : Unknown
Verified August 2015 by Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud ( Fundación Pública Andaluza Progreso y Salud ).
Recruitment status was:  Recruiting
First Posted : October 29, 2013
Last Update Posted : August 5, 2015
Sponsor:
Information provided by (Responsible Party):
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud ( Fundación Pública Andaluza Progreso y Salud )

Brief Summary:
Register of treatment of unprotected left main coronary artery stenosis in Andalucia (RETRATO).

Condition or disease Intervention/treatment
Unprotected Left Main Coronary Artery Stenosis Procedure: Coronary stent procedure (CSP) Procedure: Coronary-artery bypass grafting (CABG)

Study Type : Observational [Patient Registry]
Estimated Enrollment : 315 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Multicenter, Prospective, Observational Study of of Treatment of Unprotected Left Main Coronary Artery Stenosis in Andalucía
Study Start Date : May 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Unprotected left main coronary artery stenosis patients Procedure: Coronary stent procedure (CSP) Procedure: Coronary-artery bypass grafting (CABG)



Primary Outcome Measures :
  1. Measure the MACE survival in the coronary-artery bypass grafting (CABG) group and in the coronary stent procedure (CSP) group, to identify the differences between both groups in the short and medium-term follow up [ Time Frame: 12 months ]
    MACE= Major Adverse Cardiac Event (e.g., acute myocardial infarction, ischaemic stroke, coronary arterial occlusion, death)



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive patients with unprotected left main coronary artery stenosis in Andalucia who can follow a year monitoring in participating centers
Criteria

Inclusion Criteria:

  • New diagnosed of unprotected left main coronary artery stenosis (lesion ≥50%)
  • Have signed informed consent

Exclusion Criteria:

  • Participating in other research protocol
  • Inability to follow a monitoring

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01971749


Contacts
Contact: Carlos Sánchez González coxybum@hotmail.com
Contact: María del Mar Benjumea Vargas gestionensayosclinicos.fps@juntadeandalucia.es

Locations
Spain
Hospital Torrecárdenas Recruiting
Almería, Spain
Contact: Félix Valencia Serrano         
Hospital Universitario San Cecilio Recruiting
Granada, Spain
Contact: Juan Caballero Borrego         
Hospital Universitario Virgen de las Nieves Recruiting
Granada, Spain
Contact: Norberto Herrera Gómez         
Hospital Juan Ramón Jiménez Recruiting
Huelva, Spain
Contact: Jessica Roa Garrido         
Hospital Carlos Haya Recruiting
Málaga, Spain
Contact: Carlos Sánchez González         
Hospital Clínico Universitario Virgen de la Victoria Recruiting
Málaga, Spain
Contact: Antonio Jesús Muñoz García         
Sponsors and Collaborators
Fundación Pública Andaluza Progreso y Salud
Investigators
Principal Investigator: Carlos Sánchez González Hospital Carlos Haya

Responsible Party: Fundación Pública Andaluza Progreso y Salud
ClinicalTrials.gov Identifier: NCT01971749     History of Changes
Other Study ID Numbers: CSG-TCI-2012-01
First Posted: October 29, 2013    Key Record Dates
Last Update Posted: August 5, 2015
Last Verified: August 2015

Keywords provided by Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud ( Fundación Pública Andaluza Progreso y Salud ):
Coronary stent procedure (CSP
Coronary-artery bypass grafting (CABG)

Additional relevant MeSH terms:
Constriction, Pathologic
Coronary Stenosis
Pathological Conditions, Anatomical
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases