Clinical trial NCT03026465: Vessel Injury in Relation With Strut Thickness Assessed by OCT
Official title: Vessel Injury in Relation With Strut Thickness Assessed by OCT (VISTA): A Comparison of Vascular Injury Induced by a Polymer Free Sirolimus and Probucol Eluting Stent and a Biodegradable-polymer Biolimus-eluting Stent
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Lead sponsor: Fundacion Investigacion Interhospitalaria Cardiovascular
Sponsor class: OTHER
Collaborators: name: B.Braun Surgical SA
First posted: 2017-01-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: OCT-based intimal injury score
timeFrame: Up to 1 day (evaluated after stent implantation)
Secondary outcomes:
measure: Tissue prolapse area
timeFrame: Up to 1 day (evaluated after stent implantation)
measure: Incidence of stent malapposition
timeFrame: Up to 1 day (evaluated after stent implantation)
measure: Incidence of stent underexpansion
timeFrame: Up to 1 day (evaluated after stent implantation)
measure: Stent symmetry after implantation
timeFrame: Up to 1 day (evaluated after stent implantation)
measure: Baseline plaque type
timeFrame: Up to 1 day (evaluated after stent implantation)
Other outcomes:
Locations:
city: Vigo
country: Spain
facility: Complejo Hospitalario Universitario de Vigo
state: Pontevedra
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
Study officials:
affiliation: Hospital Clinico San Carlos de Madrid
name: Nieves Gonzalo, MD, PhD
role: STUDY_DIRECTOR
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