Coronary artery disease. Coronary atherosclerosis
Conditions
Interventions
Percutaneous coronary intervention of de-novo non-complex obstructive coronary
lesions using the FANTOM ENCORE sirolimus-Eluting BRS. Mechanical behavior and
healing pattern of the device will be as
Sponsors
Trialbureau Cardiologie
Eligibility
Age
18 Years to 99 Years
Inclusion 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 ACS. - 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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Device-oriented composite endpoint (DOCE), a composite of cardiac death, target vessel-related non-fatal myocardial infarction and clinically-driven target lesion revascularization. | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical endpoints: - Subcomponents of DOCE at 30 days, 6, 12, 24, 36, 48 and 60 months. - Target vessel revascularization (TVR) at 30 days, 6, 12, 24, 36, 48 and 60 months. - Definite or probable stent thrombosis (ST) at 30 days, 6, 12, 24, 36, 48 and 60 months. Angiographic endpoints: At baseline - Acute gain - Acute recoil - Incidence of procedural complications (dissection >B, perforation, vessel closure, slow flow or no-reflow, intra-procedure scaffold thrombosis) At 13 months follow-up - In-device late lumen loss (LLL) - In-segment LLL - In-device binary restenosis rate - In-segment binary restenosis rate Device performance: - Device success - Procedural success Intracoronary imaging (OCT): At baseline: - Incomplete strut apposition (ISA) - Scaffold expansion - Scaffold eccentricity index - Scaffold symmetry index - Edge dissection - In-device endothelial shear stress - In-segment endothelial shear stress At 13 months follow-up: - Neointima thickness - Percentage of patent struts - Percentage of uncovered struts - Persistent ISA - Acquired ISA - Scaffold eccentricity index - Scaffold symmetry index - Changes in scaffold area - In-device late lumen area loss - In-segment late lumen area loss - In-device binary restenosis rate - In-segment binary restenosis rate - In-device endothelial shear stress - In-segment endothelial shear stress | — |
Countries
Netherlands
Outcome results
None listed