FANTOM ENCORE Sirolimus-eluting Bioresorbable Scaffold for Treatment of De-novo CAD: the ENCORE-I Study
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Myocardial Revascularization
- Percutaneous Coronary Intervention
- Tomography, Optical Coherence
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Prospective, multicentre, non-randomized, investigator-initiated studyMasking: None (Open Label)Primary Purpose: Other
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Up to 50 consecutive participants with de-novo non-complex obstructive coronary lesions and non-ST elevation acute coronay syndromes or stable angina pectoris will be included in the Netherlands and Belgium. Device performance and behaviour will be assessed by angiography and optical coherence tomog...
Up to 50 consecutive participants with de-novo non-complex obstructive coronary lesions and non-ST elevation acute coronay syndromes or stable angina pectoris will be included in the Netherlands and Belgium. Device performance and behaviour will be assessed by angiography and optical coherence tomography at the index procedure and at 13 months follow-up.
Tracking Information
- NCT #
- NCT04591938
- Collaborators
- Horizon 2020 - European Commission
- REVA Medical, Inc.
- Investigators
- Principal Investigator: Joost Daemen, MD, PhD Erasmus Medical Center
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