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

October 12, 2020 updated by: Joost Daemen

Safety and Efficacy of the FANTOM ENCORE Sirolimus-eluting Bioresorbable Scaffold for Treatment of De-novo Coronary Artery Disease: the ENCORE-I Study

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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 tomography at the index procedure and at 13 months follow-up.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Belgium
      • Genk, Belgium
        • Not yet recruiting
        • Ziekenhuis Oost-Limburg
        • Contact:
          • Jo Dens, Prof. Dr.
      • Leuven, Belgium
        • Not yet recruiting
        • Universitair Ziekenhuis Leuven
        • Contact:
          • Tom Adriaenssens, Prof. Dr.
  • Netherlands
      • Rotterdam, Netherlands
        • Recruiting
        • Erasmus Medical Center
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 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

Exclusion Criteria:

  • 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.
  • Patient is receiving chronic oral or intravenous immunosuppressive therapy or has known life-limiting immunosuppressive or autoimmune disease (diabetes mellitus is not an exclusion criteria).
  • Patient has a co-morbidity, which reduces life expectancy to ≤ 24 months, or social-economic factors making compliance with the study requirements difficult.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Single arm
Fantom Encore Bioresorbable scaffold implantation
Device: Fantom Encore Bioresorbable scaffold implantation
Fantom Encore Bioresorbable scaffold implantation

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Device-Oriented Composite Endpoint (DOCE)
Time Frame: 12 months
A composite of cardiac death, target vessel-related non-fatal myocardial infarction (MI) and clinically-driven target lesion revascularization(CD-TLR).
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Subcomponents of DOCE
Time Frame: 30 days, 6, 12, 24, 36, 48 and 60 months
Subcomponents of the Device-Oriented Composite Endpoints
30 days, 6, 12, 24, 36, 48 and 60 months
Target vessel revascularization (TVR)
Time Frame: 30 days, 6, 12, 24, 36, 48 and 60 months
Target vessel revascularization
30 days, 6, 12, 24, 36, 48 and 60 months
Definite or probable stent thrombosis (ST)
Time Frame: 30 days, 6, 12, 24, 36, 48 and 60 months
Stent thrombosis
30 days, 6, 12, 24, 36, 48 and 60 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Angiographic outcomes at baseline
Time Frame: 0 days
Acute gain
0 days
Angiographic outcomes at baseline
Time Frame: 0 days
acute recoil
0 days
Angiographic outcomes at baseline
Time Frame: 0 days
Incidence of procedural complications (dissection >B, perforation, vessel closure, slow flow or no-reflow, intra-procedure scaffold thrombosis)
0 days
Angiographic outcomes at follow-up
Time Frame: 13 months
In-device and in-segment late lumen loss (LLL)
13 months
Angiographic outcomes at follow-up
Time Frame: 13 months
In-device and in-segment binary restenosis rate
13 months
Device performance
Time Frame: 0 days
Device success
0 days
Device performance
Time Frame: 0 days
Procedural success
0 days
Optical coherence tomography outcomes at baseline
Time Frame: 0 days
Incomplete strut apposition (ISA)
0 days
Optical coherence tomography outcomes at baseline
Time Frame: 0 days
Scaffold expansion
0 days
Optical coherence tomography outcomes at baseline
Time Frame: 0 days
Scaffold eccentricity
0 days
Optical coherence tomography outcomes at baseline
Time Frame: 0 days
Scaffold symmetry index
0 days
Optical coherence tomography outcomes at baseline
Time Frame: 0 days
Edge dissection
0 days
Optical coherence tomography outcomes at baseline
Time Frame: 0 days
In-device and in-segment endothelial shear stress
0 days
Optical coherence tomography outcomes at follow-up
Time Frame: 13 months
Neointima thickness
13 months
Optical coherence tomography outcomes at follow-up
Time Frame: 13 months
Percentage of patent struts
13 months
Optical coherence tomography outcomes at follow-up
Time Frame: 13 months
Percentage of uncovered struts
13 months
Optical coherence tomography outcomes at follow-up
Time Frame: 13 months
Persistent ISA
13 months
Optical coherence tomography outcomes at follow-up
Time Frame: 13 months
Acquired ISA
13 months
Optical coherence tomography outcomes at follow-up
Time Frame: 13 months
Scaffold eccentricity index
13 months
Optical coherence tomography outcomes at follow-up
Time Frame: 13 months
Scaffold symmetry index
13 months
Optical coherence tomography outcomes at follow-up
Time Frame: 13 months
In-device and in-segment late lumen area loss
13 months
Optical coherence tomography outcomes at follow-up
Time Frame: 13 months
In-device and in-segment binary restenosis rate.
13 months
Optical coherence tomography outcomes at follow-up
Time Frame: 13 months
In-device and in-segment endothelial shear stress
13 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Joost Daemen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Horizon 2020 - European Commission
REVA Medical, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Joost Daemen, MD, PhD, Erasmus Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 6, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 12, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 19, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 19, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 12, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ENCORE-I

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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