Evidence map›Paper›PMID 29662897›Full record

ArticleBioMed research international2018

Novel Compliant Scaffold with Specific Design for Venous System: Results of a Porcine Model Study.

Pierfrancesco Veroux, Alessia Giaquinta, Carla Virgilio, Davide Danilo Zani, Giuliano Ravasio, Vincenzo Ardita, Paola Secchiero, Eugenio Scanziani, Paolo Zamboni, Massimiliano Veroux

Registry-linked trialOpen access · hybridAbstract read
In one paragraph

Article in BioMed research international, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04352218 (Novel Compliant Scaffold With Specific Design for the Treatment of Non-thrombotic Stenosis of Internal Jugular Veins in Patients With Chronic Headache Poor Responder to Best Medical Therapy), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.4field-weighted citation impact, top 37% of its field
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.

NCT04352218 phase2unknown statusnot on this mapstarted 2020, after this paper: background citation

Novel Compliant Scaffold With Specific Design for the Treatment of Non-thrombotic Stenosis of Internal Jugular Veins in Patients With Chronic Headache Poor Responder to Best Medical Therapy

TypeinterventionalSponsorUniversity of CataniaRan2020 to 2022Enrolled60ConditionsHeadache, Jugular Vein OcclusionArmsPTA + Stenting using "Petalo stent", Percutaneous Transluminal Angioplasty (PTA)
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
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 at 4 institutions in 1 country.

Pierfrancesco VerouxVascular Surgery and Organ Transplant Unit, Department of Surgery, University Hospital of Catania, Catania, Italy.
Alessia GiaquintaVascular Surgery and Organ Transplant Unit, Department of Surgery, University Hospital of Catania, Catania, Italy.
Carla VirgilioVascular Surgery and Organ Transplant Unit, Department of Surgery, University Hospital of Catania, Catania, Italy.
Davide Danilo ZaniVeterinary University Hospital, School of Veterinary Medicine, University of Milan, Milan, Italy.
Giuliano RavasioVeterinary University Hospital, School of Veterinary Medicine, University of Milan, Milan, Italy.
Vincenzo ArditaVascular Surgery and Organ Transplant Unit, Department of Surgery, University Hospital of Catania, Catania, Italy.
Paola SecchieroDepartment of Morphology, Surgery and Experimental Medicine and LLTA Center, University of Ferrara, Ferrara, Italy.
Eugenio ScanzianiMouse and Animal Pathology Lab (MAPLab), Filarete Foundation, Milan, Italy.
Paolo ZamboniVascular Disease Center and Institute of Translational Medicine and Surgery, University of Ferrara, Ferrara, Italy.ORCID 0000-0002-7107-888X
Massimiliano VerouxVascular Surgery and Organ Transplant Unit, Department of Surgery, University Hospital of Catania, Catania, Italy.ORCID 0000-0002-2780-6421
University of Catania · ITUniversity of Ferrara · ITUniversity of Milan · ITFondazione Filarete · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundStenting has become the first-line treatment of obstructive venous disease because of poor results of balloon angioplasty. This preclinical study aimed to investigate the safety and efficacy profile of a novel compliant venous scaffold (CVS) denominated Petalo CVS, specifically designed for venous diseases. MATERIALS AND

methodsTwelve healthy pigs weighing 90 kg were used to test Petalo CVS. The devices were implanted into the internal jugular veins (IJVs) using a femoral vein percutaneous approach. The safety profile including the success rate of device releasing, anchoring, and positioning was evaluated immediately. Fracture, migration, primary patency, and endothelial response were assessed at 1, 2, 3, and 6 months after the study procedure.

resultsA total of 32 devices were successfully released in both IJVs. No procedure- or device-related complications were reported, and all pigs successfully completed the different scheduled follow-up periods. The primary patency rate was 100%, and no fracture or migration of the device into the brachiocephalic trunk was reported. Histological examination revealed only minimal lesions with minimal or absent inflammatory reaction surrounding the incorporated metallic rods.

conclusionsThis porcine model study showed a promising safety and efficacy profile of Petalo CVS, a novel endovenous device based on specific concepts.

Indexed as

Models, AnimalAnimalsFemoral VeinImplants, ExperimentalJugular VeinsKaplan-Meier EstimateStentsSus scrofaTissue ScaffoldsVascular Patency

Identifiers

PMID29662897
PMCPMC5832035
OpenAlexW2786644819

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Registered trials

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 OpenQuestion graph.