Register of Treatment of Unprotected Left Main Coronary Artery Stenosis in Andalucía

Unprotected Left Main Coronary Artery Stenosis Clinical Trial

— RETRATO  

Official title:

Multicenter, Prospective, Observational Study of of Treatment of Unprotected Left Main Coronary Artery Stenosis in Andalucía

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01971749
• Other study ID #: CSG-TCI-2012-01
• Status: Recruiting
• Phase: N/A
• First received: October 18, 2013
• Last updated: August 4, 2015
• Start date: May 2013
• Est. completion date: May 2016

Study information

• Verified date: August 2015
• Source: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
• Contact: Carlos Sánchez González
• Email: coxybum[@]hotmail.com
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 315
• Est. completion date: May 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Constriction, Pathologic
• Coronary Stenosis
• Unprotected Left Main Coronary Artery Stenosis

Intervention

Procedure:
• Coronary stent procedure (CSP)

• Coronary-artery bypass grafting (CABG)

Locations

Country	Name	City	State
Spain	Hospital Torrecárdenas	Almería
Spain	Hospital Universitario San Cecilio	Granada
Spain	Hospital Universitario Virgen de las Nieves	Granada
Spain	Hospital Juan Ramón Jiménez	Huelva
Spain	Hospital Carlos Haya	Málaga
Spain	Hospital Clínico Universitario Virgen de la Victoria	Málaga

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Pública Andaluza Progreso y Salud

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	MACE= Major Adverse Cardiac Event (e.g., acute myocardial infarction, ischaemic stroke, coronary arterial occlusion, death)	12 months	Yes