Percutaneous Coronary InterventionNCT04591938
FANTOM ENCORE Sirolimus-eluting Bioresorbable Scaffold for Treatment of De-novo CAD: the ENCORE-I Study
A study testing Fantom Encore Bioresorbable scaffold implantation in people with Percutaneous Coronary Intervention and Myocardial Revascularization, run by Joost Daemen at 3 sites in 2 countries.
Trial summary
Prospective, multicentre, non-randomized, investigator-initiated study aiming to assess the safety and efficacy of the Fantom Encore sirolimus-eluting bioresorbable scaffold (BRS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Percutaneous Coronary Intervention, Myocardial Revascularization, Tomography, Optical Coherence
- What is being tested?
- Fantom Encore Bioresorbable scaffold implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Oct 2019to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 17Show fewer
- 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.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Belgium2 sites, 2 recruiting
- Not yet recruiting
Ziekenhuis Oost-Limburg
Genk
Jo Dens, Prof. Dr.
- Not yet recruiting
Universitair Ziekenhuis Leuven
Leuven
Tom Adriaenssens, Prof. Dr.
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus Medical Center
Rotterdam
Joost Daemen, MD;PhD, Tel: +31 10 703 5260, j.daemen@erasmusmc.nl
Maria Natalia Tovar Forero, MD, Tel: +31 10 703 8896, m.tovarforero@erasmusmc.nl
About this study
Official title: 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).
Read the 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.
- Conditions
- Percutaneous Coronary Intervention, Myocardial Revascularization, Tomography, Optical Coherence
- Being tested
- Fantom Encore Bioresorbable scaffold implantation
- Keywords
- Bioresorbable scaffold, Percutaneous Coronary Intervention, OCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fantom Encore Bioresorbable scaffold implantationDevice
Fantom Encore Bioresorbable scaffold implantation
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Other | Fantom Encore Bioresorbable scaffold implantation Receives: Device: Fantom Encore Bioresorbable scaffold implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months
Secondary outcomes (3)
Subcomponents of DOCE
Subcomponents of the Device-Oriented Composite Endpoints
Measured: 30 days, 6, 12, 24, 36, 48 and 60 months
Target vessel revascularization (TVR)
Target vessel revascularization
Measured: 30 days, 6, 12, 24, 36, 48 and 60 months
Definite or probable stent thrombosis (ST)
Stent thrombosis
Measured: 30 days, 6, 12, 24, 36, 48 and 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 Oct 2019
- Primary completion1 Jun 2021 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous Coronary InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, multicentre, non-randomized, investigator-initiated study
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joost Daemen
- Sponsor type
- University, hospital or other
- Collaborators
- Horizon 2020 - European Commission, REVA Medical, Inc.
- Responsible party
- Sponsor-investigator, Joost Daemen, Erasmus Medical Center
- Investigators
- Joost Daemen, MD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04591938
- Sponsor's protocol ID
- ENCORE-I
- Status last verified
- Oct 2020
- First submitted
- 6 Oct 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of the FANTOM ENCORE Sirolimus-eluting Bioresorbable Scaffold for Treatment of De-novo Coronary Artery Disease: the ENCORE-I Study
- ClinicalTrials.gov ID
- NCT04591938
- Acronym / sponsor ID
- ENCORE-I
- Conditions
- Percutaneous Coronary Intervention, Myocardial Revascularization, Tomography, Optical Coherence
- Keywords
- Bioresorbable scaffold, Percutaneous Coronary Intervention, OCT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Joost DaemenUniversity, hospital or other
- Collaborators
- Horizon 2020 - European Commission, REVA Medical, Inc.
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, multicentre, non-randomized, investigator-initiated study aiming to assess the safety and efficacy of the Fantom Encore sirolimus-eluting bioresorbable scaffold (BRS).
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, multicentre, non-randomized, investigator-initiated study
| Arm | Type | Receives |
|---|---|---|
| Single arm | Other | Device: Fantom Encore Bioresorbable scaffold implantationFantom Encore Bioresorbable scaffold implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fantom Encore Bioresorbable scaffold implantationFantom Encore Bioresorbable scaffold implantation | Device | Single arm |
Primary outcome
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).
3 secondary outcomes
Subcomponents of DOCE
Time frame: 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
Definite or probable stent thrombosis (ST)
Time frame: 30 days, 6, 12, 24, 36, 48 and 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joost Daemen, MD, PhD principal investigator
Erasmus Medical Center
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fantom Encore Bioresorbable scaffold implantation in people with Percutaneous Coronary Intervention and Myocardial Revascularization, run by Joost Daemen at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joost Daemen, MD, PhD (+31 10 703 5260, j.daemen@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device-Oriented Composite Endpoint (DOCE) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.