Vessel Injury in Relation With Strut Thickness Assessed by OCT (VISTA)

Fundacion Investigacion Interhospitalaria Cardiovascular

Status and phase: Completed; Phase 4

Conditions: Coronary Artery Disease

Treatments: Device: Polymer-free stent; Device: Biodegradable-polymer stent

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03026465

VISTA

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Coroflex ISAR stent

Experimental group

Description:

PCI with a polymer-free dual-drug sirolimus- and probucol-eluting stent (Coroflex ISAR stent) with very thin struts (50 µm). During the PCI, an OCT assessment (baseline and post-implantation) will be performed.

Treatment:

Device: Polymer-free stent

Biomatrix stent

Active Comparator group

Description:

PCI with a biodegradable-polymer biolimus-eluting stent (Biomatrix stent) with 120 µm struts. During the PCI, an OCT assessment (baseline and post-implantation) will be performed.

Treatment:

Device: Biodegradable-polymer stent