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Safety & Performance Study of the FANTOM Sirolimus-Eluting Bioresorbable Coronary Scaffold

NCT02539966 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 272

Last updated 2025-04-04

No results posted yet for this study

Summary

The FANTOM II trial is intended to assess safety and performance of the Fantom Bioresorbable Coronary Scaffold in native coronary arteries.

Conditions

Interventions

DEVICE

Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold

Bioresorbable Drug-Eluting Scaffold Implantation for the Treatment of Coronary Artery Disease

Sponsors & Collaborators

  • REVA Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Alexandre Abizaid, MD, PhD · Instituto Dante Pazzanese de Cardiologia

  • Christoph K Naber, PD Dr. med · Elisabeth-Krankenhaus Essen

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2019-08-31
Completion
2024-09-30

Countries

  • Australia
  • Belgium
  • Brazil
  • Denmark
  • France
  • Germany
  • Netherlands
  • Poland

Study Locations

More Related Trials

Entities

Diseases

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 NCT02539966 on ClinicalTrials.gov