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

August 20, 2019 updated by: Nieves Gonzalo, Fundacion Investigacion Interhospitalaria Cardiovascular

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain
        • Hospital Universitario de La Princesa
    • Pontevedra
      • Vigo, Pontevedra, Spain
        • Complejo Hospitalario Universitario de Vigo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Coroflex ISAR stent
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.
Device: Polymer-free stent
PCI using a polymer-free dual-drug sirolimus- and probucol-eluting stent (Coroflex ISAR)
Other Names:
  • Coroflex ISAR
ACTIVE_COMPARATOR: Biomatrix stent
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.
Device: Biodegradable-polymer stent
PCI using a biodegradable-polymer biolimus-eluting stent (Biomatrix)
Other Names:
  • Biomatrix

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 1 day (evaluated after stent implantation)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 1 day (evaluated after stent implantation)
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
Up to 1 day (evaluated after stent implantation)
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
Up to 1 day (evaluated after stent implantation)
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
Up to 1 day (evaluated after stent implantation)
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)
Up to 1 day (evaluated after stent implantation)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion Investigacion Interhospitalaria Cardiovascular

Collaborators

B.Braun Surgical SA

Investigators

  • Study Director: Nieves Gonzalo, MD, PhD, Hospital Clínico San Carlos de Madrid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 16, 2017

Primary Completion (ACTUAL)

July 27, 2018

Study Completion (ACTUAL)

July 27, 2018

Study Registration Dates

First Submitted

October 28, 2016

First Submitted That Met QC Criteria

January 17, 2017

First Posted (ESTIMATE)

January 20, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 21, 2019

Last Update Submitted That Met QC Criteria

August 20, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VISTA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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