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

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: Recruiting
• Conditions: Percutaneous Coronary Intervention; Tomography, Optical Coherence; Myocardial Revascularization
• Intervention / Treatment: Device: Fantom Encore Bioresorbable scaffold implantation

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: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joost Daemen, MD, PhD; Phone Number: +31 10 703 5260; Email: j.daemen@erasmusmc.nl

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: Joost Daemen, MD;PhD; Phone Number: Tel: +31 10 703 5260; Email: j.daemen@erasmusmc.nl
    • Contact: Maria Natalia Tovar Forero, MD; Phone Number: Tel: +31 10 703 8896; Email: m.tovarforero@erasmusmc.nl

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subcomponents of DOCE	Subcomponents of the Device-Oriented Composite Endpoints	30 days, 6, 12, 24, 36, 48 and 60 months
Target vessel revascularization (TVR)	Target vessel revascularization	30 days, 6, 12, 24, 36, 48 and 60 months
Definite or probable stent thrombosis (ST)	Stent thrombosis	30 days, 6, 12, 24, 36, 48 and 60 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Angiographic outcomes at baseline	Acute gain	0 days
Angiographic outcomes at baseline	acute recoil	0 days
Angiographic outcomes at baseline	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	In-device and in-segment late lumen loss (LLL)	13 months
Angiographic outcomes at follow-up	In-device and in-segment binary restenosis rate	13 months
Device performance	Device success	0 days
Device performance	Procedural success	0 days
Optical coherence tomography outcomes at baseline	Incomplete strut apposition (ISA)	0 days
Optical coherence tomography outcomes at baseline	Scaffold expansion	0 days
Optical coherence tomography outcomes at baseline	Scaffold eccentricity	0 days
Optical coherence tomography outcomes at baseline	Scaffold symmetry index	0 days
Optical coherence tomography outcomes at baseline	Edge dissection	0 days
Optical coherence tomography outcomes at baseline	In-device and in-segment endothelial shear stress	0 days
Optical coherence tomography outcomes at follow-up	Neointima thickness	13 months
Optical coherence tomography outcomes at follow-up	Percentage of patent struts	13 months
Optical coherence tomography outcomes at follow-up	Percentage of uncovered struts	13 months
Optical coherence tomography outcomes at follow-up	Persistent ISA	13 months
Optical coherence tomography outcomes at follow-up	Acquired ISA	13 months
Optical coherence tomography outcomes at follow-up	Scaffold eccentricity index	13 months
Optical coherence tomography outcomes at follow-up	Scaffold symmetry index	13 months
Optical coherence tomography outcomes at follow-up	In-device and in-segment late lumen area loss	13 months
Optical coherence tomography outcomes at follow-up	In-device and in-segment binary restenosis rate.	13 months
Optical coherence tomography outcomes at follow-up	In-device and in-segment endothelial shear stress	13 months

Collaborators and Investigators

• Sponsor: Joost Daemen
• Collaborators: Horizon 2020 - European Commission; REVA Medical, Inc.
• Investigators: Principal Investigator: Joost Daemen, MD, PhD, Erasmus Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: October 6, 2020
• First Submitted That Met QC Criteria: October 12, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 12, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: OCT; Percutaneous Coronary Intervention; Bioresorbable scaffold
• Other Study ID 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