Vessel Injury in Relation With Strut Thickness Assessed by OCT

Fundacion Investigacion Interhospitalaria Cardiovascular50 enrolled

Overview

The objective of the present study is to determine the relation between vascular injury induced by the stent and strut thickness.

Thinner struts produce less arterial injury after stent implantation.The objective of the present study is to determine the relation between vascular injury induced by the stent and strut thickness. Vessel injury after stent implantation will be evaluated with optical coherence tomography (OCT). Two stents platforms with different strut thickness (Coroflex ISAR 50 microns and Biomatrix 120 microns) will be compared.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Coronary Artery Disease

Interventions

Polymer-free stentDEVICE

PCI using a polymer-free dual-drug sirolimus- and probucol-eluting stent (Coroflex ISAR)

Biodegradable-polymer stentDEVICE

PCI using a biodegradable-polymer biolimus-eluting stent (Biomatrix)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients older than 18 years * Ischemic symptoms or evidence of myocardial ischemia (inducible or spontaneous) in the presence of \>50% de novo stenosis located in native coronary vessels Exclusion Criteria: * Target lesion located in the left main stem * STEMI * Restenosis * Cardiogenic shock * Malignancies or other comorbid conditions with life expectancy less than 12 months or that may result in protocol noncompliance * Known allergy to the study medications (probucol, sirolimus, zotarolimus) * Pregnancy (present, suspected, or planned)

Locations (3)

Complejo Hospitalario Universitario de Vigo

Vigo, Pontevedra, Spain

Hospital Clinico San Carlos

Madrid, Spain

Hospital Universitario de La Princesa

Madrid, Spain