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
Prospective, multicentre, non-randomized, investigator-initiated study aiming to assess the safety and efficacy of the Fantom Encore sirolimus-eluting bioresorbable scaffold (BRS).
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. |
Country | Name | City | State |
---|---|---|---|
Belgium | Ziekenhuis Oost-Limburg | Genk | |
Belgium | Universitair Ziekenhuis Leuven | Leuven | |
Netherlands | Erasmus Medical Center | Rotterdam |
Lead Sponsor | Collaborator |
---|---|
Joost Daemen | Horizon 2020 - European Commission, REVA Medical, Inc. |
Belgium, Netherlands,
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 |
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