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The FAST OCT Study

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ClinicalTrials.gov Identifier: NCT04683133
Recruitment Status : Recruiting
First Posted : December 24, 2020
Last Update Posted : December 24, 2020
Sponsor:
Collaborators:
Abbott
Pie Medical Imaging
Information provided by (Responsible Party):
Joost Daemen, Erasmus Medical Center

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.

Condition or disease Intervention/treatment Phase
Tomography, Optical Coherence Myocardial Revascularization NSTEMI - Non-ST Segment Elevation MI Unstable Angina Coronary Arteriosclerosis 3D-angio-based FFR Diagnostic Test: Optical coherence tomography assessment Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, multicenter, international, no-randomized, single-arm, investigator-initiated study
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Association Between 3D Quantitative Angiography Based FFR and Luminal Obstruction as Detected by Optical Coherence Tomography (OCT): the FAST OCT Study
Actual Study Start Date : December 1, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Arm Intervention/treatment
Single arm
Optical coherence tomography evaluation of coronary arteries with intermediate to severe stenosis.
Diagnostic Test: Optical coherence tomography assessment
Optical coherence tomography assessment of coronary arteries with intermediate to severe stenosis




Primary Outcome Measures :
  1. The association between 3D-angio-based FFR and OCT detected minimum luminal area pre- and post-PCI [ Time Frame: 0 days ]
    The association between 3D-angio-based FFR and OCT detected minimum luminal area pre- and post-PCI


Secondary Outcome Measures :
  1. The association between 3D-angio-based FFR values and OCT detected causes of luminal obstruction pre-PCI [ Time Frame: 0 days ]
    The association between 3D-angio-based FFR values and OCT detected causes of luminal obstruction pre-PCI

  2. The association between 3D-angio-based FFR values and OCT detected causes of luminal obstruction post-PCI [ Time Frame: 0 days ]
    The association between 3D-angio-based FFR values and OCT detected causes of luminal obstruction post-PCI

  3. Accuracy of 3D-angio-based FFR to detect intraluminal obstructions pre-PCI [ Time Frame: 0 days ]
    Accuracy of 3D-angio-based FFR to detect intraluminal obstructions pre-PCI

  4. Accuracy of 3D-angio-based FFR to detect intraluminal obstructions post-PCI [ Time Frame: 0 days ]
    Accuracy of 3D-angio-based FFR to detect intraluminal obstructions post-PCI



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04683133


Locations
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Netherlands
Erasmus Medical Center Recruiting
Rotterdam, Netherlands
Contact: Joost Daemen, MD;PhD    +31 10 703 5260    j.daemen@erasmusmc.nl   
Contact: Maria Natalia Tovar Forero, MD    +31 10 703 8896    m.tovarforero@erasmusmc.nl   
Principal Investigator: Joost Daemen, MD;PhD         
Sub-Investigator: Maria Natalia Tovar Forero, MD         
Sponsors and Collaborators
Erasmus Medical Center
Abbott
Pie Medical Imaging
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Responsible Party: Joost Daemen, Interventional Cardiologist, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT04683133    
Other Study ID Numbers: The FAST OCT study
First Posted: December 24, 2020    Key Record Dates
Last Update Posted: December 24, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Joost Daemen, Erasmus Medical Center:
OCT
3D-angio-based FFR
Coronary Arteriosclerosis
NST-ACS
Additional relevant MeSH terms:
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Arteriosclerosis
Angina, Unstable
Coronary Artery Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Angina Pectoris
Heart Diseases
Chest Pain
Pain
Neurologic Manifestations
Coronary Disease