To assess the safety and efficacy of the FANTOM ENCORE sirolimus-eluting BRS.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Device-oriented composite endpoint (DOCE), a composite of cardiac death, target
vessel-related non-fatal myocardial infarction and clinically-driven target
lesion revascularization.
Secondary outcome
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
Background summary
In patients with coronary artery disease who receive metallic drug-eluting
coronary stents, adverse events such as late target-lesion failure may be
related in part to the persistent presence of the metallic stent frame in the
coronary vessel wall. Bioresorbable scaffolds (BRS) have been developed to
attempt to improve long-term outcomes. Following the excellent result of the
first generation FANTOM BRS up to 2 years, the next generation FANTOM ENCORE
BRS received Conformité Européene (CE) mark on June 18, 2018. The available
diameters 2.5, 3.0 and 3.5 offer different and smaller strut thickness (95, 105
and 115 micron, respectively) as compared to its predecessor (125 micron),
potentially allowing a smoother and faster vessel healing with lower
inter-strut flow disturbances, while maintaining similar mechanical properties
and x-ray visibility, which could potentially reduce the incidence of future
adverse cardiac events. Intracoronary imaging with optical coherence tomography
(OCT) will provide a close look at the acute performance and the long-term
healing profile of the device.
Study objective
To assess the safety and efficacy of the FANTOM ENCORE sirolimus-eluting BRS.
Study design
Prospective, multicentre, non-randomized, investigator-initiated study.
Intervention
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 assessed with optical coherence
tomography performed at baseline (pre- and post-procedure) and at 13months
follow-up.
Study burden and risks
The FANTOM ENCORE has received CE Mark approval and its use will follow
standard practice for PCI and the instructions for use, with careful patient
and lesion selection. Available data on the previous FANTOM BRS generation
demonstrate that the device is safe with a target lesion failure rate of 5% at
24 months as compared to Absorb BVS or Xience (11% and 7.9% respectively).
Patients will receive standard care which includes double antiplatelet therapy,
statins and lifestyle changes recommendations according to current European
guidelines. OCT will be performed to guide the procedure and at 13-months
follow-up according to current ESC-EAPCI task force on the evaluation and use
of BRS guidelines; previous studies have demonstrated that OCT guidance of PCI
is a safe technique and can potentially improve clinical outcomes when compared
to angiography alone; in cases of BRS implantation, OCT enhance vessel and
device selection, deployment evaluation and healing profile. The potential
risks of this study include the known risks of any currently used standard
procedure to assess and to treat obstructive coronary artery disease. Patients
participating in this study will potentially benefit from receiving transitory
vessel scaffolding with the newest generation of thinner strut BRS.
Doctor Molewaterplein 40
Rotterdam 3015 GD
NL
Doctor Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
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 <= 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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL69644.078.19 |