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

Joost Daemen

Status

Enrolling

Conditions

Percutaneous Coronary Intervention

Myocardial Revascularization

Tomography, Optical Coherence

Treatments

Device: Fantom Encore Bioresorbable scaffold implantation

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04591938

ENCORE-I

Details and patient eligibility

About

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

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.