The FAST OCT Study

• Sponsor: Erasmus Medical Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04683133
• Collaborator: Abbott (Industry), Pie Medical Imaging (Other)
• Enrollment: 200
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 13
• Patients Per Site Per Month: 15.4

Study Details

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.

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	N/A

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Prospective, multicenter, international, no-randomized, single-arm, investigator-initiated studyProspective, 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: Dec 1, 2020
• Anticipated Primary Completion Date: Dec 31, 2021
• Anticipated Study Completion Date: Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: 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

Outcome Measures

Primary Outcome Measures

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

   Accuracy of 3D-angio-based FFR to detect intraluminal obstructions post-PCI

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Erasmus Medical Center	Rotterdam		Netherlands

Sponsors and Collaborators

• Erasmus Medical Center
• Abbott
• Pie Medical Imaging

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Joost Daemen, Interventional Cardiologist, Erasmus Medical Center
• ClinicalTrials.gov Identifier: NCT04683133
• Other Study ID Numbers: The FAST OCT study
• First Posted: Dec 24, 2020
• Last Update Posted: Dec 24, 2020
• Last Verified: Dec 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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, Interventional Cardiologist, Erasmus Medical Center: OCT; 3D-angio-based FFR; Coronary Arteriosclerosis; NST-ACS
• Additional relevant MeSH terms: Arteriosclerosis; Angina, Unstable; Coronary Artery Disease; Myocardial Ischemia

Study Results

No Results Posted as of Dec 24, 2020