Using a bioresorbable scaffold to treat coronary artery disease
Safety and Efficacy of the FANTOM ENCORE Sirolimus-eluting Bioresorbable Scaffold for Treatment of De-novo Coronary Artery Disease: the ENCORE-I Study
This study is testing a new type of heart device to see if it can safely help people with blocked arteries feel better and improve their heart health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Locations | 3 sites (Genk and 2 other locations) |
| Trial ID | NCT04591938 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of the Fantom Encore sirolimus-eluting bioresorbable scaffold in patients with de-novo non-complex obstructive coronary lesions. It is a prospective, multicenter, non-randomized study that will include up to 50 participants experiencing stable angina or non-ST elevation acute coronary syndromes. Participants will undergo implantation of the scaffold, with device performance assessed through angiography and optical coherence tomography at the procedure and again at 13 months follow-up.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with stable or unstable angina or non-ST elevation acute myocardial infarction and specific coronary lesion characteristics.
Not a fit: Patients with heavily calcified lesions, severe tortuosity, or those requiring alternative treatment devices may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a safer and more effective treatment option for patients with coronary artery disease.
How similar studies have performed: Previous studies on bioresorbable scaffolds have shown promise, but this specific approach is still being evaluated for its efficacy.
Eligibility criteria
Show full inclusion / exclusion 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 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.
Where this trial is running
Genk and 2 other locations
- Ziekenhuis Oost-Limburg — Genk, Belgium (Not_yet_recruiting)
- Universitair Ziekenhuis Leuven — Leuven, Belgium (Not_yet_recruiting)
- Erasmus Medical Center — Rotterdam, Netherlands (Recruiting)
Study contacts
- Principal investigator: Joost Daemen, MD, PhD — Erasmus Medical Center
- Study coordinator: Joost Daemen, MD, PhD
- Email: j.daemen@erasmusmc.nl
- Phone: +31 10 703 5260
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.