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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Iniciativa Andaluza en Terapias Avanzadas - Fundación Pública Andaluza Progreso y Salud
Sponsor:
Information provided by (Responsible Party):
Iniciativa Andaluza en Terapias Avanzadas - Fundación Pública Andaluza Progreso y Salud
ClinicalTrials.gov Identifier:
NCT01971749
First received: October 18, 2013
Last updated: April 28, 2014
Last verified: April 2014

October 18, 2013
April 28, 2014
May 2013
May 2015   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
MACE= Major Adverse Cardiac Event (e.g., acute myocardial infarction, ischaemic stroke, coronary arterial occlusion, death)
Same as current
Complete list of historical versions of study NCT01971749 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Register of Treatment of Unprotected Left Main Coronary Artery Stenosis in Andalucía
Multicenter, Prospective, Observational Study of of Treatment of Unprotected Left Main Coronary Artery Stenosis in Andalucía

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

Not Provided
Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
2 Years
Not Provided
Non-Probability Sample

Consecutive patients with unprotected left main coronary artery stenosis in Andalucia who can follow a year monitoring in participating centers

Unprotected Left Main Coronary Artery Stenosis
  • Procedure: Coronary stent procedure (CSP)
  • Procedure: Coronary-artery bypass grafting (CABG)
Unprotected left main coronary artery stenosis patients
Interventions:
  • Procedure: Coronary stent procedure (CSP)
  • Procedure: Coronary-artery bypass grafting (CABG)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
315
December 2015
May 2015   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact: Carlos Sánchez González coxybum@hotmail.com
Contact: María del Mar Benjumea Vargas gestionensayosclinicos.fps@juntadeandalucia.es
Spain
 
NCT01971749
CSG-TCI-2012-01
No
Iniciativa Andaluza en Terapias Avanzadas - Fundación Pública Andaluza Progreso y Salud
Iniciativa Andaluza en Terapias Avanzadas - Fundación Pública Andaluza Progreso y Salud
Not Provided
Principal Investigator: Carlos Sánchez González Hospital Carlos Haya
Iniciativa Andaluza en Terapias Avanzadas - Fundación Pública Andaluza Progreso y Salud
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP