Clinical trial NCT04591938: FANTOM ENCORE Sirolimus-eluting Bioresorbable Scaffold for Treatment of De-novo CAD: the ENCORE-I 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Percutaneous Coronary Intervention
Myocardial Revascularization
Tomography, Optical Coherence
Keywords: Bioresorbable scaffold
Percutaneous Coronary Intervention
OCT
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Horizon 2020 - European Commission
name: REVA Medical, Inc.
First posted: 2020-10-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, multicentre, non-randomized, investigator-initiated study
Primary purpose: OTHER

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.

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 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.

Primary outcomes:
measure: Device-Oriented Composite Endpoint (DOCE)
timeFrame: 12 months
Secondary outcomes:
measure: Subcomponents of DOCE
timeFrame: 30 days, 6, 12, 24, 36, 48 and 60 months
measure: Target vessel revascularization (TVR)
timeFrame: 30 days, 6, 12, 24, 36, 48 and 60 months
measure: Definite or probable stent thrombosis (ST)
timeFrame: 30 days, 6, 12, 24, 36, 48 and 60 months
Other outcomes:
measure: Angiographic outcomes at baseline
timeFrame: 0 days
measure: Angiographic outcomes at baseline
timeFrame: 0 days
measure: Angiographic outcomes at baseline
timeFrame: 0 days
measure: Angiographic outcomes at follow-up
timeFrame: 13 months
measure: Angiographic outcomes at follow-up
timeFrame: 13 months
measure: Device performance
timeFrame: 0 days
measure: Device performance
timeFrame: 0 days
measure: Optical coherence tomography outcomes at baseline
timeFrame: 0 days
measure: Optical coherence tomography outcomes at baseline
timeFrame: 0 days
measure: Optical coherence tomography outcomes at baseline
timeFrame: 0 days
measure: Optical coherence tomography outcomes at baseline
timeFrame: 0 days
measure: Optical coherence tomography outcomes at baseline
timeFrame: 0 days
measure: Optical coherence tomography outcomes at baseline
timeFrame: 0 days
measure: Optical coherence tomography outcomes at follow-up
timeFrame: 13 months
measure: Optical coherence tomography outcomes at follow-up
timeFrame: 13 months
measure: Optical coherence tomography outcomes at follow-up
timeFrame: 13 months
measure: Optical coherence tomography outcomes at follow-up
timeFrame: 13 months
measure: Optical coherence tomography outcomes at follow-up
timeFrame: 13 months
measure: Optical coherence tomography outcomes at follow-up
timeFrame: 13 months
measure: Optical coherence tomography outcomes at follow-up
timeFrame: 13 months
measure: Optical coherence tomography outcomes at follow-up
timeFrame: 13 months
measure: Optical coherence tomography outcomes at follow-up
timeFrame: 13 months
measure: Optical coherence tomography outcomes at follow-up
timeFrame: 13 months
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
Study officials:
affiliation: Erasmus Medical Center
name: Joost Daemen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: