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

Percutaneous Coronary Intervention Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04591938
• Other study ID #: ENCORE-I
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: December 31, 2025

Study information

• Verified date: October 2020
• Source: Erasmus Medical Center
• Contact: Joost Daemen, MD, PhD
• Phone: +31 10 703 5260
• Email: j.daemen[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2025
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Myocardial Revascularization
• Percutaneous Coronary Intervention
• Tomography, Optical Coherence

Intervention

Device:
• Fantom Encore Bioresorbable scaffold implantation
Fantom Encore Bioresorbable scaffold implantation

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg	Genk
Belgium	Universitair Ziekenhuis Leuven	Leuven
Netherlands	Erasmus Medical Center	Rotterdam

Sponsors (3)

Lead Sponsor	Collaborator
Joost Daemen	Horizon 2020 - European Commission, REVA Medical, Inc.

Countries where clinical trial is conducted

Belgium,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Angiographic outcomes at baseline	Acute gain	0 days
Other	Angiographic outcomes at baseline	acute recoil	0 days
Other	Angiographic outcomes at baseline	Incidence of procedural complications (dissection >B, perforation, vessel closure, slow flow or no-reflow, intra-procedure scaffold thrombosis)	0 days
Other	Angiographic outcomes at follow-up	In-device and in-segment late lumen loss (LLL)	13 months
Other	Angiographic outcomes at follow-up	In-device and in-segment binary restenosis rate	13 months
Other	Device performance	Device success	0 days
Other	Device performance	Procedural success	0 days
Other	Optical coherence tomography outcomes at baseline	Incomplete strut apposition (ISA)	0 days
Other	Optical coherence tomography outcomes at baseline	Scaffold expansion	0 days
Other	Optical coherence tomography outcomes at baseline	Scaffold eccentricity	0 days
Other	Optical coherence tomography outcomes at baseline	Scaffold symmetry index	0 days
Other	Optical coherence tomography outcomes at baseline	Edge dissection	0 days
Other	Optical coherence tomography outcomes at baseline	In-device and in-segment endothelial shear stress	0 days
Other	Optical coherence tomography outcomes at follow-up	Neointima thickness	13 months
Other	Optical coherence tomography outcomes at follow-up	Percentage of patent struts	13 months
Other	Optical coherence tomography outcomes at follow-up	Percentage of uncovered struts	13 months
Other	Optical coherence tomography outcomes at follow-up	Persistent ISA	13 months
Other	Optical coherence tomography outcomes at follow-up	Acquired ISA	13 months
Other	Optical coherence tomography outcomes at follow-up	Scaffold eccentricity index	13 months
Other	Optical coherence tomography outcomes at follow-up	Scaffold symmetry index	13 months
Other	Optical coherence tomography outcomes at follow-up	In-device and in-segment late lumen area loss	13 months
Other	Optical coherence tomography outcomes at follow-up	In-device and in-segment binary restenosis rate.	13 months
Other	Optical coherence tomography outcomes at follow-up	In-device and in-segment endothelial shear stress	13 months
Primary	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	Subcomponents of DOCE	Subcomponents of the Device-Oriented Composite Endpoints	30 days, 6, 12, 24, 36, 48 and 60 months
Secondary	Target vessel revascularization (TVR)	Target vessel revascularization	30 days, 6, 12, 24, 36, 48 and 60 months
Secondary	Definite or probable stent thrombosis (ST)	Stent thrombosis	30 days, 6, 12, 24, 36, 48 and 60 months