Status:
UNKNOWN
The FAST OCT Study
Lead Sponsor:
Erasmus Medical Center
Collaborating Sponsors:
Abbott
Pie Medical Imaging
Conditions:
Tomography, Optical Coherence
Myocardial Revascularization
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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) ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04683133
Start Date
December 1 2020
End Date
December 31 2021
Last Update
December 24 2020
Active Locations (1)
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1
Erasmus Medical Center
Rotterdam, Netherlands