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

NCT ID: NCT04591938

Last Updated: 2020-10-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2025-12-31

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).

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Single arm

Fantom Encore Bioresorbable scaffold implantation

Group Type: OTHER

Fantom Encore Bioresorbable scaffold implantation

Intervention Type: DEVICE

Fantom Encore Bioresorbable scaffold implantation

Interventions

Fantom Encore Bioresorbable scaffold implantation

Fantom Encore Bioresorbable scaffold implantation

Intervention Type: DEVICE

Eligibility Criteria

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 has a co-morbidity, which reduces life expectancy to ≤ 24 months, or social-economic factors making compliance with the study requirements difficult.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Horizon 2020 - European Commission

OTHER

Sponsor Role: collaborator

REVA Medical, Inc.

INDUSTRY

Sponsor Role: collaborator

Joost Daemen

OTHER

Sponsor Role: lead

Responsible Party

Joost Daemen

Interventional Cardiologist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Joost Daemen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Locations

Ziekenhuis Oost-Limburg

Genk, , Belgium

Site Status: NOT_YET_RECRUITING

Universitair Ziekenhuis Leuven

Leuven, , Belgium

Site Status: NOT_YET_RECRUITING

Erasmus Medical Center

Rotterdam, , Netherlands

Site Status: RECRUITING

Countries

Belgium; Netherlands

Central Contacts

Joost Daemen, MD, PhD

Role: CONTACT

j.daemen@erasmusmc.nl

+31 10 703 5260

Facility Contacts

Jo Dens, Prof. Dr.

Role: primary

Tom Adriaenssens, Prof. Dr.

Role: primary

Joost Daemen, MD;PhD

Role: primary

j.daemen@erasmusmc.nl

Tel: +31 10 703 5260

Maria Natalia Tovar Forero, MD

Role: backup

m.tovarforero@erasmusmc.nl

Tel: +31 10 703 8896

Other Identifiers

ENCORE-I

Identifier Type: -

Identifier Source: org_study_id