Evidence map›Paper›PMID 39665865›Full record

ArticleAnnals of biomedical engineering2025

A Novel In Silico-Ex Vivo Model for Correlating Coating Transfer to Tissue with Local Drug-Coated Balloon-Vessel Contact Pressures.

Efstathios Stratakos, Linnea Tscheuschner, Lorenzo Vincenzi, Edoardo Pedrinazzi, Fragiska Sigala, Luca D'Andrea, Dario Gastaldi, Francesca Berti, Abraham Rami Tzafriri, Giancarlo Pennati

Abstract read
In one paragraph

Article in Annals of biomedical engineering, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Efstathios StratakosLaboratory of Biological Structure Mechanics, Department of Chemistry, Materials and Chemical Engineering "Giulio Natta", Politecnico di Milano, 20133, Milan, Italy. efstathios.stratakos@polimi.it.ORCID http://orcid.org/0009-0008-6156-392X
Linnea TscheuschnerDepartment of Vascular Surgery, National and Kapodistrian University of Athens, 15772, Athens, Greece.
Lorenzo VincenziLaboratory of Biological Structure Mechanics, Department of Chemistry, Materials and Chemical Engineering "Giulio Natta", Politecnico di Milano, 20133, Milan, Italy.
Edoardo PedrinazziLaboratory of Biological Structure Mechanics, Department of Chemistry, Materials and Chemical Engineering "Giulio Natta", Politecnico di Milano, 20133, Milan, Italy.
Fragiska SigalaDepartment of Vascular Surgery, National and Kapodistrian University of Athens, 15772, Athens, Greece.
Luca D'AndreaLaboratory of Biological Structure Mechanics, Department of Chemistry, Materials and Chemical Engineering "Giulio Natta", Politecnico di Milano, 20133, Milan, Italy.
Dario GastaldiLaboratory of Biological Structure Mechanics, Department of Chemistry, Materials and Chemical Engineering "Giulio Natta", Politecnico di Milano, 20133, Milan, Italy.
Francesca BertiLaboratory of Biological Structure Mechanics, Department of Chemistry, Materials and Chemical Engineering "Giulio Natta", Politecnico di Milano, 20133, Milan, Italy.
Abraham Rami TzafririDepartment of Research and Innovation, CBSET Inc., Lexington, MA, 02421, USA.
Giancarlo PennatiLaboratory of Biological Structure Mechanics, Department of Chemistry, Materials and Chemical Engineering "Giulio Natta", Politecnico di Milano, 20133, Milan, Italy.

Funding

H2020 Marie Skłodowska-Curie Actions 956470
6 · The paper itself

Abstract

Drug-coated balloons (DCBs) aim to deliver drug-loaded surface coating upon inflation at specific vascular sites, yet the role of inflation pressure remains to be defined. We implement a new approach combining ex vivo stamping experiments with in silico simulations to study acute coating transfer by commercial DCBs. This methodology comprises 3 essential pillars: (I) DCB resin inflation and slicing into cylindrical segments for subsequent stamping onto porcine-excised tissue, (II) Numerical inflation of a full DCB replica in an idealized porcine vessel to predict in vivo interfacial contact pressures (CPs) and subsequent interfacial-level numerical stamping to calculate appropriate benchtop forces that recreate these in vivo CP values, and (III) ex vivo stamping experiments and optical analysis of the stamped surfaces (DCB segment and arterial tissue), using a standard high-resolution camera to visualize coating. High-performance liquid chromatography (HPLC) was employed as a validated assay for quantifying drug in tissue samples post-stamping. HPLC analysis revealed a significant correlation with image processing, confirming the validity of the optical method as a tool to quantify DCB coating. Image and HPLC analysis revealed a statistically significant twofold rise in coating area and drug content to tissue, respectively, when the average CP roughly doubled (0.16-0.35 atm) and a non-statistically significant increase in coating area and drug content with a further rough doubling of average CP (0.35 to 0.75 atm). Imaging of DCB segments pre- and post-stamping showed transfer of partial coating thickness at low CP, contrasting with complete transfer at high CP at the same site. 3D confocal images of DCB surfaces revealed variable thickness in the transferred coating. This study introduces a comprehensive methodology for evaluating the efficacy of commercial DCB coating transfer to arterial tissue-a crucial precursor to drug elution studies-while minimizing the number of DCBs needed and improving variable control and realism.

Indexed as

Coated Materials, BiocompatibleComputer SimulationDrug Delivery SystemsModels, CardiovascularAnimalsPressureSwineCoated Materials, BiocompatibleBenchtop experimentCoating transferContact pressureDrug-coated balloonDrug deliveryIn silico simulations

Identifiers

PMID39665865
PMCPMC11836097

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.