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The FAST OCT Study

Primary Purpose

Tomography, Optical Coherence, Myocardial Revascularization, NSTEMI - Non-ST Segment Elevation MI

Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Optical coherence tomography assessment
Sponsored by
Erasmus Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Tomography, Optical Coherence focused on measuring OCT, 3D-angio-based FFR, Coronary Arteriosclerosis, NST-ACS

Eligibility Criteria

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

Inclusion Criteria:

  • 18 years or older
  • Presenting with NST-ACS
  • At least one coronary vessel with intermediate to severe coronary stenosis (30% to 90% by visual estimation or online QCA)
  • Target vessel with a reference vessel diameter (RVD) ≥2.5 and ≤ 5.0 mm as assessed by QCA or visual estimation
  • The patient is willing to participate in the study
  • Target vessel suitable for OCT imaging

Exclusion Criteria:

  • Target vessel with a distal Thrombolysis In Myocardial Infarction (TIMI) flow <3
  • Target lesion located within 5.0 mm of vessel origin
  • Severe tortuosity
  • Chronic total occlusion of the target vessel
  • Target lesion is located in or supplied by an arterial or venous bypass graft.
  • Impaired renal function (eGFR <30ml/min) *
  • Pregnant or breastfeeding patients *
  • Patient has a known allergy to contrast medium *
  • Contraindication for the use of nitrates *
  • Life expectancy <12 months

Sites / Locations

  • Erasmus Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single arm

Arm Description

Optical coherence tomography evaluation of coronary arteries with intermediate to severe stenosis.

Outcomes

Primary Outcome Measures

The association between 3D-angio-based FFR and OCT detected minimum luminal area pre- and post-PCI
The association between 3D-angio-based FFR and OCT detected minimum luminal area pre- and post-PCI

Secondary Outcome Measures

The association between 3D-angio-based FFR values and OCT detected causes of luminal obstruction pre-PCI
The association between 3D-angio-based FFR values and OCT detected causes of luminal obstruction pre-PCI
The association between 3D-angio-based FFR values and OCT detected causes of luminal obstruction post-PCI
The association between 3D-angio-based FFR values and OCT detected causes of luminal obstruction post-PCI
Accuracy of 3D-angio-based FFR to detect intraluminal obstructions pre-PCI
Accuracy of 3D-angio-based FFR to detect intraluminal obstructions pre-PCI
Accuracy of 3D-angio-based FFR to detect intraluminal obstructions post-PCI
Accuracy of 3D-angio-based FFR to detect intraluminal obstructions post-PCI

Full Information

First Posted
December 21, 2020
Last Updated
December 21, 2020
Sponsor
Erasmus Medical Center
Collaborators
Abbott, Pie Medical Imaging
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1. Study Identification

Unique Protocol Identification Number
NCT04683133
Brief Title
The FAST OCT Study
Official Title
Association Between 3D Quantitative Angiography Based FFR and Luminal Obstruction as Detected by Optical Coherence Tomography (OCT): the FAST OCT Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasmus Medical Center
Collaborators
Abbott, Pie Medical Imaging

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This trial is designed to associate angiography-based fractional flow reserve (3D-angio-based FFR) values with optical coherence tomography findings in pre- and post-percutaneous coronary intervention in patients with non-ST segment elevation acute coronary syndromes.
Detailed Description
Prospective, multicenter, international, no-randomized, single-arm, investigator-initiated study, enrolling up to 200 patients with intermediate to severe coronary stenosis (30-90% diameter stenosis) in patients presenting with NST-ACS requiring coronary angiography assessment. Patients will receive ad-hoc OCT evaluation of the target vessels and offline 3D-angio-based FFR evaluation. The primary study parameter is the association between 3D-angio-based FFR values and OCT detected minimum luminal area pre- and post-PCI

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tomography, Optical Coherence, Myocardial Revascularization, NSTEMI - Non-ST Segment Elevation MI, Unstable Angina, Coronary Arteriosclerosis, 3D-angio-based FFR
Keywords
OCT, 3D-angio-based FFR, Coronary Arteriosclerosis, NST-ACS

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, multicenter, international, no-randomized, single-arm, investigator-initiated study
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single arm
Arm Type
Other
Arm Description
Optical coherence tomography evaluation of coronary arteries with intermediate to severe stenosis.
Intervention Type
Diagnostic Test
Intervention Name(s)
Optical coherence tomography assessment
Intervention Description
Optical coherence tomography assessment of coronary arteries with intermediate to severe stenosis
Primary Outcome Measure Information:
Title
The association between 3D-angio-based FFR and OCT detected minimum luminal area pre- and post-PCI
Description
The association between 3D-angio-based FFR and OCT detected minimum luminal area pre- and post-PCI
Time Frame
0 days
Secondary Outcome Measure Information:
Title
The association between 3D-angio-based FFR values and OCT detected causes of luminal obstruction pre-PCI
Description
The association between 3D-angio-based FFR values and OCT detected causes of luminal obstruction pre-PCI
Time Frame
0 days
Title
The association between 3D-angio-based FFR values and OCT detected causes of luminal obstruction post-PCI
Description
The association between 3D-angio-based FFR values and OCT detected causes of luminal obstruction post-PCI
Time Frame
0 days
Title
Accuracy of 3D-angio-based FFR to detect intraluminal obstructions pre-PCI
Description
Accuracy of 3D-angio-based FFR to detect intraluminal obstructions pre-PCI
Time Frame
0 days
Title
Accuracy of 3D-angio-based FFR to detect intraluminal obstructions post-PCI
Description
Accuracy of 3D-angio-based FFR to detect intraluminal obstructions post-PCI
Time Frame
0 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years or older Presenting with NST-ACS At least one coronary vessel with intermediate to severe coronary stenosis (30% to 90% by visual estimation or online QCA) Target vessel with a reference vessel diameter (RVD) ≥2.5 and ≤ 5.0 mm as assessed by QCA or visual estimation The patient is willing to participate in the study Target vessel suitable for OCT imaging Exclusion Criteria: Target vessel with a distal Thrombolysis In Myocardial Infarction (TIMI) flow <3 Target lesion located within 5.0 mm of vessel origin Severe tortuosity Chronic total occlusion of the target vessel Target lesion is located in or supplied by an arterial or venous bypass graft. Impaired renal function (eGFR <30ml/min) * Pregnant or breastfeeding patients * Patient has a known allergy to contrast medium * Contraindication for the use of nitrates * Life expectancy <12 months
Facility Information:
Facility Name
Erasmus Medical Center
City
Rotterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joost Daemen, MD;PhD
Phone
+31 10 703 5260
Email
j.daemen@erasmusmc.nl
First Name & Middle Initial & Last Name & Degree
Maria Natalia Tovar Forero, MD
Phone
+31 10 703 8896
Email
m.tovarforero@erasmusmc.nl
First Name & Middle Initial & Last Name & Degree
Joost Daemen, MD;PhD
First Name & Middle Initial & Last Name & Degree
Maria Natalia Tovar Forero, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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