The FAST OCT Study

Last updated: December 21, 2020
Sponsor: Erasmus Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Disease

Cardiac Ischemia

Atherosclerosis

Treatment

N/A

Clinical Study ID

NCT04683133
The FAST OCT study
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 byQCA or visual estimation
  • The patient is willing to participate in the study
  • Target vessel suitable for OCT imaging

Exclusion

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

Study Design

Total Participants: 200
Study Start date:
December 01, 2020
Estimated Completion Date:
December 31, 2021

Study 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

Connect with a study center

  • Erasmus Medical Center

    Rotterdam,
    Netherlands

    Active - Recruiting

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