Myocardial Revascularization, Percutaneous Coronary Intervention, Tomography, Optical Coherence
Conditions
Keywords
Bioresorbable scaffold, Percutaneous Coronary Intervention, OCT
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.
Interventions
DEVICEFantom Encore Bioresorbable scaffold implantation
Fantom Encore Bioresorbable scaffold implantation
Sponsors
Horizon 2020 - European Commission
REVA Medical, Inc.
Joost Daemen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Prospective, multicentre, non-randomized, investigator-initiated study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device-Oriented Composite Endpoint (DOCE) | 12 months | A composite of cardiac death, target vessel-related non-fatal myocardial infarction (MI) and clinically-driven target lesion revascularization(CD-TLR). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subcomponents of DOCE | 30 days, 6, 12, 24, 36, 48 and 60 months | Subcomponents of the Device-Oriented Composite Endpoints |
| Target vessel revascularization (TVR) | 30 days, 6, 12, 24, 36, 48 and 60 months | Target vessel revascularization |
| Definite or probable stent thrombosis (ST) | 30 days, 6, 12, 24, 36, 48 and 60 months | Stent thrombosis |
Other
| Measure | Time frame | Description |
|---|---|---|
| Angiographic outcomes at baseline | 0 days | Acute gain |
| Optical coherence tomography outcomes at follow-up | 13 months | Neointima thickness |
| Angiographic outcomes at follow-up | 13 months | In-device and in-segment late lumen loss (LLL) |
| Device performance | 0 days | Device success |
| Optical coherence tomography outcomes at baseline | 0 days | Incomplete strut apposition (ISA) |
Countries
Belgium, Netherlands
Contacts
Primary ContactJoost Daemen, MD, PhD
Outcome results
None listed