Fantom (sirolimus-eluting bioresorbable scaffold) / REVA Medical - LARVOL DELTA

FANTOM II: Safety & Performance Study of the FANTOM Sirolimus-Eluting Bioresorbable Coronary Scaffold (clinicaltrials.gov) - P=N/A | N=272 | Completed | Sponsor: REVA Medical, Inc. | Active, not recruiting ➔ Completed

Trial completion • Cardiovascular • Coronary Artery Disease

FANTOM II: Safety & Performance Study of the FANTOM Sirolimus-Eluting Bioresorbable Coronary Scaffold (clinicaltrials.gov) - P=N/A | N=220 | Active, not recruiting | Sponsor: REVA Medical, Inc. | Trial completion date: Feb 2024 ➔ Sep 2024

Trial completion date • Cardiovascular • Coronary Artery Disease

MOTIV BTK Randomized Controlled Trial (clinicaltrials.gov) - P=N/A | N=292 | Recruiting | Sponsor: REVA Medical, Inc. | Trial completion date: Mar 2028 ➔ Mar 2029 | Trial primary completion date: Sep 2023 ➔ Sep 2025

Trial completion date • Trial primary completion date • Cardiovascular • Peripheral Arterial Disease

FANTOM II: Safety & Performance Study of the FANTOM Sirolimus-Eluting Bioresorbable Coronary Scaffold (clinicaltrials.gov) - P=N/A | N=220 | Active, not recruiting | Sponsor: REVA Medical, Inc. | Trial completion date: Mar 2023 ➔ Feb 2024 | Recruiting ➔ Active, not recruiting

Enrollment closed • Trial completion date • Cardiovascular • Coronary Artery Disease

Pilot Study of the Fantom Bioresorbable Scaffold (FANTOM I) (clinicaltrials.gov) - P=N/A | N=7 | Completed | Sponsor: REVA Medical, Inc. | Unknown status ➔ Completed

Trial completion • Cardiovascular • Coronary Artery Disease

FANTOM Post Market Clinical Trial (clinicaltrials.gov) - P=N/A | N=1500 | Recruiting | Sponsor: REVA Medical, Inc. | Trial primary completion date: May 2021 ➔ May 2025

Trial primary completion date • Cardiovascular • Coronary Artery Disease

MOTIV BTK Randomized Controlled Trial (clinicaltrials.gov) - P=N/A | N=292 | Recruiting | Sponsor: REVA Medical, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Peripheral Arterial Disease

MOTIV BTK Randomized Controlled Trial (clinicaltrials.gov) - P=N/A | N=292 | Not yet recruiting | Sponsor: REVA Medical, Inc.

New trial • Peripheral Arterial Disease

An experimental investigation into the physical, thermal and mechanical degradation of a polymeric bioresorbable scaffold. (PubMed, J Mech Behav Biomed Mater) - "This study presents a comprehensive evaluation of the mechanical, micro-mechanical and physical properties of Reva Medical Fantom Encore Bioresorbable Scaffolds (BRS) subjected to a thermally-accelerated degradation protocol...Limited changes were observed in nano-mechanical properties, with measured local elastic moduli and hardness values remaining largely similar throughout degradation. Given that the thermally-accelerated in vitro conditions represented a four-fold acceleration of physiological conditions, these results suggest that the BRS scaffolds could exhibit substantially brittle behaviour after ∼ one year of implantation."

Journal • Musculoskeletal Diseases • Orthopedics

From the real device to the digital twin: A coupled experimental-numerical strategy to investigate a novel bioresorbable vascular scaffold. (PubMed, PLoS One) - "The object of the work is the Fantom® Encore polymeric stent (REVA Medical) made of Tyrocore™...Moreover, radial force testing was numerically performed and compared with literature data. The obtained results demonstrated the effectiveness of the digital twin development pipeline, a path applicable to any commercial device whose geometric structure is based on repetitive units."

Journal

Differential analysis of gene expression across the human genome using recount2 and FANTOM-CAT (AACR 2018) - "Overall, this analysis revealed a set of molecular signatures encompassing coding and non-coding genes that are shared across cancer types or restricted to specific tissues of origin.In summary, our findings establish the FANTOM-CAT/recount2 gene expression atlas as a reliable resource to study the role ncRNAs play in cancer and other human diseases, providing important cues to understand their biological function. Finally, we make the FANTOM-CAT/recount2 atlas available as a public tool to empower other researchers to study important biological and clinical phenotypes and identify new candidate ncRNAs for further investigation."

Oncology

Development of a superenhancer element-associated transcription factor signature in primary tumors for the identification of liver metastasis in colorectal cancer patients (AACR 2018) - "...Keeping this in mind, we undertook an effort to develop a TF-based gene expression signature in primary CRC tissues that can help identify patients with a metastatic disease. A comprehensive list of TFs was established from key relevant databases including TFdb, FANTOM and TFCAT... We present a TF gene expression signature that can identify liver metastasis and can predict poor survival by analyzing primary tumor tissues from CRC patients. Transcriptional cooperativity between 7 of these 14 TFs along with their enriched binding to key superenhancer elements underscores their functional role in metastasis."

Clinical • Colorectal Cancer • Hepatocellular Cancer

FANTOM ENCORE Sirolimus-eluting Bioresorbable Scaffold for Treatment of De-novo CAD: the ENCORE-I Study (clinicaltrials.gov) - P=N/A; N=50; Recruiting; Sponsor: Joost Daemen

Clinical • New trial • Cardiovascular • Coronary Artery Disease

"#FF @homeless2hearth @NTDOPowerCouple @nintendocouple @FantomComics @PinkGorillaLLC @TheHouseOfMario @BehindHops @AmDiabetesAssn" (@flapjackashley)

Biosimilar • Diabetes • Metabolic Disorders

An integrated expression atlas of miRNAs and their promoters in human and mouse. (PubMed, Nat Biotechnol) - "...As part of the fifth edition of the Functional Annotation of Mammalian Genome (FANTOM5) project, we created an integrated expression atlas of miRNAs and their promoters by deep-sequencing 492 short RNA (sRNA) libraries, with matching Cap Analysis Gene Expression (CAGE) data, from 396 human and 47 mouse RNA samples...We also found that primary and mature miRNA expression levels were correlated, allowing us to use the primary miRNA measurements as a proxy for mature miRNA levels in a total of 1,829 human and 1,029 mouse CAGE libraries. We thus provide a broad atlas of miRNA expression and promoters in primary mammalian cells, establishing a foundation for detailed analysis of miRNA expression patterns and transcriptional control regions."

Journal • Biosimilar

Accumulation of Proatherogenic Metabolite Trimethylamine-N-Oxide and Gut Microbiome in Patients with Type 2 Diabetes Mellitus and Chronic Kidney Disease (KIDNEY WEEK 2016) - "FMO3 transcript expressions were extracted from FANTOM 5 database. The elevated level of TMAO in T2DM CKD patients is associated with increased number of TMA producing bacteria in addition to poor renal clearance. Restoration of normal gut microbiome and control of FMO3 expression could significantly modulate thisproatherogenic metabolite."

Clinical • Biosimilar • Chronic Kidney Disease • Diabetes • Diabetic Nephropathy • Multiple Sclerosis • Renal Disease

Relevance of tissue specific subunit expression in channelopathies. (PubMed, Neuropharmacology) - "...We further focused on the tissue distribution of voltage-gated calcium channel (VGCC) genes including different brain areas and the retina based on the human gene expression from the FANTOM5 dataset. The expression data is complemented by an overview of the tissue-dependent aspects of L-type calcium channel (LTCC) function, dysfunction and pharmacology, as well as of their splice variants. Finally, we focus on the pathology of tissue-restricted LTCC channelopathies and their treatment options."

Journal • Review • Biosimilar • Ophthalmology

Ultrathin Bioresorbable-Polymer Sirolimus-Eluting Stents Versus Thin Durable-Polymer Everolimus-Eluting Stents in Patients Undergoing Coronary Revascularization: Three-Year Outcomes From the Randomized BIOFLOW V Trial (CRT 2020) - P=NA, N=1,334; BIOFLOW-V (NCT02389946); Sponsor: Biotronik, Inc.; "In a large randomized trial, both TLF and the individual outcomes of target vessel MI and clinically driven TLR at 3-years follow-up were significantly lower among patients treated with BP SES versus DP EES. Late/very late definite stent thrombosis was also significantly lower among patients treated with BP SES. The outperformance of this ultrathin BP SES in a complex patient population undergoing percutaneous coronary intervention suggests a new direction in improving next-generation DES technology."

Clinical data

Long-Term Serial Functional Evaluation After Implantation of the Fantom Sirolimus-Eluting Bioresorbable Coronary Scaffold: The FANTOM II study (TCT 2019) - "Conclusion Serial angiographic analysis showed significant increase in QFR values between baseline and post-PCI. A slight decrease was observed in QFR values with the Fantom BRS over 24 months."

FANTOM II Trial: Safety and Performance Study of the Fantom Sirolimus-Eluting Bioresorbable Coronary Scaffold: First Report on Initial 48-Month Outcomes (TCT 2019) - "Conclusion The results continue to be encouraging and confirm the initial safety and performance outcomes of the Fantom scaffold. Patient follow-up is ongoing through 5 years."

Clinical

Second generation, sirolimus-eluting, bioresorbable Tyrocore scaffold implantation in patients with ST-segment elevation myocardial infarction: Baseline OCT and 30-day clinical outcomes - A FANTOM STEMI pilot study. (PubMed, Catheter Cardiovasc Interv) - "This is the first pilot study evaluating safety and efficacy of the Fantom BRS, a second generation fully bioresorbable coronary scaffold, in STEMI patients undergoing primary PCI with OCT guidance. Fantom BRS showed adequate safety and efficacy in the acute 30-day angiographic, OCT, and clinical follow-up."

Clinical • Clinical data • Journal

HEDD: Human Enhancer Disease Database. (PubMed, Nucleic Acids Res) - "It also provides Web-based analytical tools to visualize enhancer networks and score enhancers given a set of selected genes in a specific gene network. HEDD is freely accessible at http://zdzlab.einstein.yu.edu/1/hedd.php."

Journal

Alternative start and termination sites of transcription drive most transcript isoform differences across human tissues. (PubMed, Nucleic Acids Res) - "...We confirmed the widespread tissue-dependent use of alternative transcription start sites in a second, independent dataset, Cap Analysis of Gene Expression data from the FANTOM consortium. Moreover, our results indicate that most tissue-dependent splicing involves untranslated exons and therefore may not increase proteome complexity. Thus, alternative transcription start and termination sites are the principal drivers of transcript isoform diversity across tissues, and may underlie the majority of cell type specific proteomes and functions."

Journal

Mechanical performance and healing patterns of the novel sirolimus-eluting bioresorbable Fantom scaffold: 6-month and 9-month follow-up by optical coherence tomography in the FANTOM II study. (PubMed, Open Heart) - "The novel Fantom BRS had favourable healing patterns at 6-month and 9-month follow-up as malapposition was effectively resolved and strut coverage was almost complete. The scaffold remained stable through follow-up with no signs of systematic late recoil."

Journal