FANTOM ENCORE Sirolimus-eluting Bioresorbable Scaffold for Treatment of De-novo CAD: the ENCORE-I Study

Launched by JOOST DAEMEN · Oct 12, 2020

Keywords

ClinConnect Summary

The FANTOM ENCORE study is looking at a new type of treatment for patients with certain heart conditions. Specifically, it is testing the safety and effectiveness of a special device called a bioresorbable scaffold, which is designed to help open up blocked arteries in the heart. This device releases a medication called sirolimus that helps prevent the artery from becoming blocked again. The study is open to adults aged 18 and older who have stable or unstable angina (chest pain) or other related heart issues, and who have specific types of blockages in their coronary arteries.

Participants in the study will undergo procedures to place this scaffold in their arteries and will receive follow-up evaluations to monitor their progress. To join the study, patients should have a blockage that is more than 50% and can meet other specific criteria related to their heart health and current medications. It’s important to note that there are some conditions that would exclude a patient from participating, such as severe kidney problems or certain heart conditions. Overall, this study aims to provide valuable information about a new approach to treating heart disease, which could benefit many patients in the future.

Gender

ALL

Eligibility 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.