NCT04591938

Brief Summary

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

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Longer than P75 for not_applicable

Geographic Reach
2 countries

3 active sites

Status
unknown

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

October 1, 2019

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

October 6, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
4.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

October 19, 2020

Status Verified

October 1, 2020

Enrollment Period

1.7 years

First QC Date

October 6, 2020

Last Update Submit

October 12, 2020

Conditions

Percutaneous Coronary InterventionMyocardial RevascularizationTomography, Optical Coherence

Keywords

Bioresorbable scaffoldPercutaneous Coronary InterventionOCT

Outcome Measures

Primary Outcomes (1)

  • Device-Oriented Composite Endpoint (DOCE)

    A composite of cardiac death, target vessel-related non-fatal myocardial infarction (MI) and clinically-driven target lesion revascularization(CD-TLR).

    12 months

Secondary Outcomes (3)

  • Subcomponents of DOCE

    30 days, 6, 12, 24, 36, 48 and 60 months

  • Target vessel revascularization (TVR)

    30 days, 6, 12, 24, 36, 48 and 60 months

  • Definite or probable stent thrombosis (ST)

    30 days, 6, 12, 24, 36, 48 and 60 months

Other Outcomes (23)

  • Angiographic outcomes at baseline

    0 days

  • Angiographic outcomes at baseline

    0 days

  • Angiographic outcomes at baseline

    0 days

  • +20 more other outcomes

Study Arms (1)

Single arm

OTHER

Fantom Encore Bioresorbable scaffold implantation

Device: Fantom Encore Bioresorbable scaffold implantation

Interventions

Fantom Encore Bioresorbable scaffold implantationDEVICE

Fantom Encore Bioresorbable scaffold implantation

Single arm

Eligibility Criteria

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

You may qualify if:

  • years or older
  • Stable angina, unstable angina or documented silent ischemia (invasive or non-invasive test) or non-ST segment elevation acute myocardial infarction.
  • De-novo non-complex coronary obstructive lesions (\>50% stenosis as assessed by quantitative coronary analysis (QCA))
  • The patient is willing and able to comply with the specified follow-up evaluations.
  • Reference vessel diameter (RVD) ≥ 2.5 mm and ≤ 4.0 mm by QCA.
  • During pre-dilatation, the pre-dilatation balloon is uniformly expanded to the full intended diameter.
  • Target segment suitable for OCT imaging

You may not qualify if:

  • Target vessel with a distal Thrombolysis In Myocardial Infarction (TIMI) flow 0 or 1.
  • Target lesion located within 5.0 mm of vessel origin.
  • Lesion type ACC/AHA C.
  • Heavily calcified lesion
  • Severe tortuosity
  • Target lesion is located in or supplied by an arterial or venous bypass graft.
  • Target lesion requires treatment with a device other than the pre-dilatation balloon prior to scaffold placement (including but not limited to directional coronary atherectomy, excimer laser, rotational atherectomy, etc.).
  • Unsuccessful pre-dilatation, defined as a residual diameter stenosis ≥ 30%, assessed by QCA.
  • Planned future revascularization of non-culprit lesions.
  • Presence of another device (stent or scaffold) located within the same segment (5mm from the target lesion borders).
  • Patient is currently participating in another study with an investigational device or an investigational drug and has not completed the entire follow-up period.
  • Impaired renal function (eGFR \<30ml/min).
  • Patient has a contraindication for the use of double antiplatelet therapy for at least 12 months.
  • Pregnant or breastfeeding patients.
  • Patient has a known allergy to contrast medium, sirolimus, Tyrosine-derived polycarbonate or other structurally related compounds.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Ziekenhuis Oost-Limburg

Genk, Belgium

NOT YET RECRUITING

Universitair Ziekenhuis Leuven

Leuven, Belgium

NOT YET RECRUITING

Erasmus Medical Center

Rotterdam, Netherlands

RECRUITING

Study Officials

  • Joost Daemen, MD, PhD

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joost Daemen, MD, PhD

CONTACT

+31 10 703 5260j.daemen@erasmusmc.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Prospective, multicentre, non-randomized, investigator-initiated study
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Interventional Cardiologist

Study Record Dates

First Submitted

October 6, 2020

First Posted

October 19, 2020

Study Start

October 1, 2019

Primary Completion

June 1, 2021

Study Completion

December 31, 2025

Last Updated

October 19, 2020

Record last verified: 2020-10

Locations

BE(2)NL(1)