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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Polymer-free stent
Biodegradable-polymer stent
Sponsored by
Fundacion Investigacion Interhospitalaria Cardiovascular
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Complejo Hospitalario Universitario de Vigo
  • Hospital Clinico San Carlos
  • Hospital Universitario de La Princesa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Coroflex ISAR stent

Biomatrix stent

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 28, 2016
Last Updated
August 20, 2019
Sponsor
Fundacion Investigacion Interhospitalaria Cardiovascular
Collaborators
B.Braun Surgical SA
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1. Study Identification

Unique Protocol Identification Number
NCT03026465
Brief Title
Vessel Injury in Relation With Strut Thickness Assessed by OCT
Acronym
VISTA
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

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
February 16, 2017 (Actual)
Primary Completion Date
July 27, 2018 (Actual)
Study Completion Date
July 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundacion Investigacion Interhospitalaria Cardiovascular
Collaborators
B.Braun Surgical SA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Coroflex ISAR stent
Arm Type
Experimental
Arm 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.
Arm Title
Biomatrix stent
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Polymer-free stent
Other Intervention Name(s)
Coroflex ISAR
Intervention Description
PCI using a polymer-free dual-drug sirolimus- and probucol-eluting stent (Coroflex ISAR)
Intervention Type
Device
Intervention Name(s)
Biodegradable-polymer stent
Other Intervention Name(s)
Biomatrix
Intervention Description
PCI using a biodegradable-polymer biolimus-eluting stent (Biomatrix)
Primary Outcome Measure Information:
Title
OCT-based intimal injury score
Description
OCT-based intimal injury score estimated after implantation of the Coroflex-ISAR and Biomatrix DES
Time Frame
Up to 1 day (evaluated after stent implantation)
Secondary Outcome Measure Information:
Title
Tissue prolapse area
Description
Tissue prolapse area assessed by OCT after implantation of Coroflex-ISAR and Biomatrix will be measured
Time Frame
Up to 1 day (evaluated after stent implantation)
Title
Incidence of stent malapposition
Description
Stent apposition after implantation of Coroflex-ISAR and Biomatrix as assessed by OCT
Time Frame
Up to 1 day (evaluated after stent implantation)
Title
Incidence of stent underexpansion
Description
Stent expansion will be measured with OCT after implantation of Coroflex-ISAR and Biomatrix
Time Frame
Up to 1 day (evaluated after stent implantation)
Title
Stent symmetry after implantation
Description
Stent symmetry will be measured with OCT after implantation of Coroflex-ISAR and Biomatrix
Time Frame
Up to 1 day (evaluated after stent implantation)
Title
Baseline plaque type
Description
Baseline plaque type will be assessed by OCT (fibrous, fibrocalcific or lipid-rich)
Time Frame
Up to 1 day (evaluated after stent implantation)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nieves Gonzalo, MD, PhD
Organizational Affiliation
Hospital Clinico San Carlos de Madrid
Official's Role
Study Director
Facility Information:
Facility Name
Complejo Hospitalario Universitario de Vigo
City
Vigo
State/Province
Pontevedra
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario de La Princesa
City
Madrid
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
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Vessel Injury in Relation With Strut Thickness Assessed by OCT

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