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Completed

NCT Number: NCT03026465

Vessel Injury in Relation With Strut Thickness Assessed by OCT

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

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Complejo Hospitalario Universitario de Vigo, Vigo, Pontevedra, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Polymer-free stent

Device

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

Other names: Coroflex ISAR

Biodegradable-polymer stent

Device

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

Other names: Biomatrix

Primary outcomes

  1. OCT-based intimal injury score

    Time frame: Up to 1 day (evaluated after stent implantation)

    OCT-based intimal injury score estimated after implantation of the Coroflex-ISAR and Biomatrix DES

Secondary outcomes

  1. Tissue prolapse area

    Time frame: Up to 1 day (evaluated after stent implantation)

    Tissue prolapse area assessed by OCT after implantation of Coroflex-ISAR and Biomatrix will be measured

  2. Incidence of stent malapposition

    Time frame: Up to 1 day (evaluated after stent implantation)

    Stent apposition after implantation of Coroflex-ISAR and Biomatrix as assessed by OCT

  3. Incidence of stent underexpansion

    Time frame: Up to 1 day (evaluated after stent implantation)

    Stent expansion will be measured with OCT after implantation of Coroflex-ISAR and Biomatrix

  4. Stent symmetry after implantation

    Time frame: Up to 1 day (evaluated after stent implantation)

    Stent symmetry will be measured with OCT after implantation of Coroflex-ISAR and Biomatrix

  5. Baseline plaque type

    Time frame: Up to 1 day (evaluated after stent implantation)

    Baseline plaque type will be assessed by OCT (fibrous, fibrocalcific or lipid-rich)

Sponsors and collaborators

Lead sponsor

Fundacion Investigacion Interhospitalaria Cardiovascular

Other

Collaborators

  • B.Braun Surgical SA

Registry information

Official study 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

Acronym: VISTA

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 20, 2017
Registry last updated
Aug 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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