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First-in-Man Experience with the ClearLumen Thrombectomy System as an Adjunctive Therapy in Primary Percutaneous Coronary Interventions

Biasco, Luigi ; Götberg, Matthias LU ; Harnek, Jan LU ; Lundin, Anders LU ; Kandzari, David E. ; De Backer, Ole and Olivecrona, Göran K. LU (2016) In Journal of Interventional Cardiology 29(2). p.155-161
Abstract

Objectives To describe the first-in-man experience with the ClearLumen Thrombectomy System (Walk Vascular, Irvine, CA) and report on its safety, feasibility and efficacy when used as an adjunctive therapy during primary PCI. Background Thrombus aspiration (TA) aims to improve microvascular perfusion but currently available devices are not optimal. Methods Prospective, single-centre, non-randomized, safety, and efficacy trial. Patients with acute STEMI were enrolled and the investigational device was used for thrombus aspiration. Safety was evaluated as the overall rate of device related complications while efficacy as the rate of successful device deployment and culprit vessel reperfusion. The composite endpoint based on the achievement... (More)

Objectives To describe the first-in-man experience with the ClearLumen Thrombectomy System (Walk Vascular, Irvine, CA) and report on its safety, feasibility and efficacy when used as an adjunctive therapy during primary PCI. Background Thrombus aspiration (TA) aims to improve microvascular perfusion but currently available devices are not optimal. Methods Prospective, single-centre, non-randomized, safety, and efficacy trial. Patients with acute STEMI were enrolled and the investigational device was used for thrombus aspiration. Safety was evaluated as the overall rate of device related complications while efficacy as the rate of successful device deployment and culprit vessel reperfusion. The composite endpoint based on the achievement of at least two of the following three criteria - TIMI flow 3 and/or myocardial blush grade ≥2 at completion of the case and ST-resolution >70% at 90 minutes after vessel reperfusion - was also evaluated. Results Over a 3 months period 20 patients were enrolled in the study. Culprit lesion was successfully reached with the investigational device in 19 patients (95%). The pre-specified combined endpoint was met in 16 out of 19 patients (84.2%). Three patients not meeting the combined end point had procedure related, non TA associated, adverse event. Only 2 minor procedural adverse event occurred after thrombus aspiration. Conclusions This first-in-man experience with the ClearLumen Thrombectomy System demonstrates initial promising results on safety and efficacy when used as an adjunctive therapy during primary PCI. (J Interven Cardiol 2016;29:155-161)

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publishing date
type
Contribution to journal
publication status
published
in
Journal of Interventional Cardiology
volume
29
issue
2
pages
7 pages
publisher
Wiley-Blackwell
external identifiers
  • wos:000374153600004
  • pmid:27062125
  • scopus:84962802491
ISSN
0896-4327
DOI
10.1111/joic.12285
language
English
LU publication?
yes
id
3c4e7776-1c80-4e99-b74d-43b3509fc1ad
date added to LUP
2016-06-02 16:22:36
date last changed
2023-01-06 06:16:00
@article{3c4e7776-1c80-4e99-b74d-43b3509fc1ad,
  abstract     = {{<p>Objectives To describe the first-in-man experience with the ClearLumen Thrombectomy System (Walk Vascular, Irvine, CA) and report on its safety, feasibility and efficacy when used as an adjunctive therapy during primary PCI. Background Thrombus aspiration (TA) aims to improve microvascular perfusion but currently available devices are not optimal. Methods Prospective, single-centre, non-randomized, safety, and efficacy trial. Patients with acute STEMI were enrolled and the investigational device was used for thrombus aspiration. Safety was evaluated as the overall rate of device related complications while efficacy as the rate of successful device deployment and culprit vessel reperfusion. The composite endpoint based on the achievement of at least two of the following three criteria - TIMI flow 3 and/or myocardial blush grade ≥2 at completion of the case and ST-resolution &gt;70% at 90 minutes after vessel reperfusion - was also evaluated. Results Over a 3 months period 20 patients were enrolled in the study. Culprit lesion was successfully reached with the investigational device in 19 patients (95%). The pre-specified combined endpoint was met in 16 out of 19 patients (84.2%). Three patients not meeting the combined end point had procedure related, non TA associated, adverse event. Only 2 minor procedural adverse event occurred after thrombus aspiration. Conclusions This first-in-man experience with the ClearLumen Thrombectomy System demonstrates initial promising results on safety and efficacy when used as an adjunctive therapy during primary PCI. (J Interven Cardiol 2016;29:155-161)</p>}},
  author       = {{Biasco, Luigi and Götberg, Matthias and Harnek, Jan and Lundin, Anders and Kandzari, David E. and De Backer, Ole and Olivecrona, Göran K.}},
  issn         = {{0896-4327}},
  language     = {{eng}},
  month        = {{04}},
  number       = {{2}},
  pages        = {{155--161}},
  publisher    = {{Wiley-Blackwell}},
  series       = {{Journal of Interventional Cardiology}},
  title        = {{First-in-Man Experience with the ClearLumen Thrombectomy System as an Adjunctive Therapy in Primary Percutaneous Coronary Interventions}},
  url          = {{http://dx.doi.org/10.1111/joic.12285}},
  doi          = {{10.1111/joic.12285}},
  volume       = {{29}},
  year         = {{2016}},
}