Safety and Efficacy of the FANTOM ENCORE sirolimus-eluting bioresorbable scaffold for treatment of de-novo coronary artery disease: the ENCORE-I study
- Conditions
- Coronary artery disease. Coronary atherosclerosis10011082
- Registration Number
- NL-OMON49058
- Lead Sponsor
- Trialbureau Cardiologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 26
- 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
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Device-oriented composite endpoint (DOCE), a composite of cardiac death, target<br /><br>vessel-related non-fatal myocardial infarction and clinically-driven target<br /><br>lesion revascularization. </p><br>
- Secondary Outcome Measures
Name Time Method