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FANTOM ENCORE Sirolimus-eluting Bioresorbable Scaffold for Treatment of De-novo CAD: the ENCORE-I Study

NCT04591938 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-10-19

No results posted yet for this study

Summary

Prospective, multicentre, non-randomized, investigator-initiated study aiming to assess the safety and efficacy of the Fantom Encore sirolimus-eluting bioresorbable scaffold (BRS).

Conditions

  • Percutaneous Coronary Intervention
  • Myocardial Revascularization
  • Tomography, Optical Coherence

Interventions

DEVICE

Fantom Encore Bioresorbable scaffold implantation

Fantom Encore Bioresorbable scaffold implantation

Sponsors & Collaborators

  • Horizon 2020 - European Commission

    collaborator OTHER

  • REVA Medical, Inc.

    collaborator INDUSTRY

  • Joost Daemen

    lead OTHER

Principal Investigators

  • Joost Daemen, MD, PhD · Erasmus Medical Center

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2021-06-01
Completion
2025-12-31

Countries

  • Belgium
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04591938 on ClinicalTrials.gov