NCT02512003

Brief Summary

The FANTOM I pilot study is intended to assess safety of the Fantom Bioresorbable Coronary Scaffold in native coronary arteries.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable coronary-artery-disease

Timeline
Completed

Started Dec 2014

Longer than P75 for not_applicable coronary-artery-disease

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

July 14, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 30, 2015

Completed
4.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

March 29, 2023

Status Verified

March 1, 2023

Enrollment Period

7 months

First QC Date

July 14, 2015

Last Update Submit

March 27, 2023

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Ischemia-driven Target Lesion Revascularization (TLR)

    Percent of Patients with TLR at 4 months

    4 months

Secondary Outcomes (17)

  • Quantitative Coronary Angiography (QCA) derived parameters

    4 months

  • Quantitative Coronary Angiography (QCA) derived parameters

    4 months

  • Quantitative Coronary Angiography (QCA) derived parameters

    4 months

  • Quantitative Coronary Angiography (QCA) derived parameters

    4 months

  • Quantitative Coronary Angiography (QCA) derived parameters

    4 months

  • +12 more secondary outcomes

Study Arms (1)

Fantom Treatment group

EXPERIMENTAL
Device: Fantom Scaffold

Interventions

Fantom ScaffoldDEVICE
Fantom Treatment group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient has evidence of myocardial ischemia or a positive functional study
  • Patient has a normal CK-MB
  • Target lesion has a visually estimated stenosis of ≥50% and \<100%
  • Target lesion is located in a native coronary artery with average reference vessel diameter ≥ 2.7mm and ≤ 3.3mm
  • Target lesion length must be ≤ 14mm

You may not qualify if:

  • Patient has experienced a myocardial infarction (CK-MB or Troponin \> 5 X ULN) within 72 hours of the procedure
  • Patient has a left ventricular ejection fraction \< 25%
  • Patient has unprotected lest main coronary disease with ≥50% stenosis
  • The target vessel is totally occluded (TIMI Flow 0 or 1)
  • Target lesion involves a bifurcation (a lesion with a side branch ≥ 2.0 mm in diameter containing a ≥ 50% stenosis).
  • Target lesion is located within a bypass graft
  • Target lesion has possible or definite thrombus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Instituto Dante Pazzanese de Cardiologia

São Paulo, Brazil

Location

Pracownia Kardiologii Inwazyjnej I Katedry i Kliniki Kardiologii WUM

Warsaw, Poland

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2015

First Posted

July 30, 2015

Study Start

December 1, 2014

Primary Completion

July 1, 2015

Study Completion

April 1, 2020

Last Updated

March 29, 2023

Record last verified: 2023-03

Locations

PL(1)BR(1)