Vessel Injury in Relation With Strut Thickness Assessed by OCT

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03026465

Acronym

VISTA

Enrollment

Registered

2017-01-20

Start date

2017-02-16

Completion date

2018-07-27

Last updated

2019-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

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.

Interventions

DEVICEPolymer-free stent

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

DEVICEBiodegradable-polymer stent

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame	Description
OCT-based intimal injury score	Up to 1 day (evaluated after stent implantation)	OCT-based intimal injury score estimated after implantation of the Coroflex-ISAR and Biomatrix DES

Secondary

Measure	Time frame	Description
Tissue prolapse area	Up to 1 day (evaluated after stent implantation)	Tissue prolapse area assessed by OCT after implantation of Coroflex-ISAR and Biomatrix will be measured
Incidence of stent malapposition	Up to 1 day (evaluated after stent implantation)	Stent apposition after implantation of Coroflex-ISAR and Biomatrix as assessed by OCT
Incidence of stent underexpansion	Up to 1 day (evaluated after stent implantation)	Stent expansion will be measured with OCT after implantation of Coroflex-ISAR and Biomatrix
Stent symmetry after implantation	Up to 1 day (evaluated after stent implantation)	Stent symmetry will be measured with OCT after implantation of Coroflex-ISAR and Biomatrix
Baseline plaque type	Up to 1 day (evaluated after stent implantation)	Baseline plaque type will be assessed by OCT (fibrous, fibrocalcific or lipid-rich)

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026