RapidpulseTM cyclic aspiration system for acute ischemic stroke due to large vessel occlusions

Arsida Bajrami; Serdar Geyik; Ozgur Ertugrul; Eren Erdem; Jose I Gallego Leon; Giorgio Barbieri; Carlos Dominguez Rodriguez; Jose Carlos Rayón-Aledo; Antonio I Sagredo Barra; Fernando S Sanchez Blanco; Carmen Serna Candel; Francisco Jose Montalverne; Lidemarcks I Andrade; Diego Bandeira; Jose Bezerra; Hellen Carm; Henrique Coelho Silva; Alessandra Braga Cruz Guedes de Morais; Adson Freitas de Lucena; Fabricio O Lima; George Mendes; Felipe A Rocha; Karlis Kupcs; Helmuts Kidikas; Janis Vetra; Gyula Gal; Anabel Diaz; Raul G Nogueira

doi:10.1177/15910199241239094

RapidpulseTM cyclic aspiration system for acute ischemic stroke due to large vessel occlusions

Arsida Bajrami
, Serdar Geyik
, Ozgur Ertugrul
, Eren Erdem
, Jose I Gallego Leon
, Giorgio Barbieri
, Carlos Dominguez Rodriguez
, Jose Carlos Rayón-Aledo
, Antonio I Sagredo Barra
, Fernando S Sanchez Blanco
, Carmen Serna Candel
, Francisco Jose Montalverne
, Lidemarcks I Andrade
, Diego Bandeira
, Jose Bezerra
, Hellen Carm
, Henrique Coelho Silva
, Alessandra Braga Cruz Guedes de Morais
, Adson Freitas de Lucena
, Fabricio O Lima

George Mendes, Felipe A Rocha, Karlis Kupcs, Helmuts Kidikas, Janis Vetra, Gyula Gal, Anabel Diaz, Raul G Nogueira (Corresponding Author)

Research output: Contribution to journal › Article › peer-review

3 Citations (Scopus)

Abstract

BACKGROUND: The best strategy to achieve optimal reperfusion outcomes during mechanical thrombectomy remains to be defined. The RapidPulseTM Cyclic Aspiration System is a novel technology, delivering high-frequency pulsed vacuum forces to increase the efficiency of aspiration thrombectomy.

METHODS: Prospective, multicenter, open-label, core lab-adjudicated, two-arm study comparing safety and efficacy of a feasibility version of the RapidPulseTM system compared with contemporary controls. Primary endpoint was the rate of mTICI ≥ 2c after first-pass effect (FPE). Additional efficacy endpoints were the rates of mTICI ≥ 2b after first pass (modified FPE (mFPE)), last pass with study device defined as frontline technical success, and after all passes including rescue therapy. The primary safety endpoints included symptomatic ICH (sICH) within 24 h post-procedure.

RESULTS: Between February 2022 to December 2022, 80 subjects were consented and enrolled in the study (n = 40 treatment arm, n = 40 control arm). In the intent to treat (ITT) population, mean age was 67.8 ± 11.5 years; 19 (47.5%) were male. Median NIHSS score was 16 (IQR: 13-22). Median ASPECTS score was 9 (IQR: 8-10). The rate of mTICI ≥ 2c after first pass was 53.9% in ITT population (60.0% in per-protocol population) versus 38.5% in the corresponding control population. Functional independence (mRS 0-2) at 90 days was achieved in 61.1% (22/36) in the RapidPulseTM arm and 52.8% (19/36) in the control arm. In the RapidPulseTM arm, no sICH within 24 h and no device-related morbidity or mortality occurred.

CONCLUSION: Preliminary data suggests RapidPulseTM Aspiration System is highly effective and safe for recanalization of large vessel occlusions.

Original language	English
Article number	15910199241239094
Journal	Interventional Neuroradiology
DOIs	https://doi.org/10.1177/15910199241239094
Publication status	E-pub ahead of print - 22 Mar 2024
Externally published	Yes

Keywords*

LVO
Stroke
cyclic aspiration
mechanical thrombectomy

Field of Science*

3.2 Clinical medicine

Publication Type*

1.1. Scientific article indexed in Web of Science and/or Scopus database

Access to Document

10.1177/15910199241239094

Cite this

Bajrami, A., Geyik, S., Ertugrul, O., Erdem, E., Gallego Leon, J. I., Barbieri, G., Dominguez Rodriguez, C., Rayón-Aledo, J. C., Barra, A. I. S., Blanco, F. S. S., Candel, C. S., Montalverne, F. J., Andrade, L. I., Bandeira, D., Bezerra, J., Carm, H., Silva, H. C., Braga Cruz Guedes de Morais, A., de Lucena, A. F., ... Nogueira, R. G. (2024). RapidpulseTM cyclic aspiration system for acute ischemic stroke due to large vessel occlusions. Interventional Neuroradiology, Article 15910199241239094. Advance online publication. https://doi.org/10.1177/15910199241239094

@article{27c0b3a4063d4b3eaccdaa57d8341e15,

title = "RapidpulseTM cyclic aspiration system for acute ischemic stroke due to large vessel occlusions",

abstract = "BACKGROUND: The best strategy to achieve optimal reperfusion outcomes during mechanical thrombectomy remains to be defined. The RapidPulseTM Cyclic Aspiration System is a novel technology, delivering high-frequency pulsed vacuum forces to increase the efficiency of aspiration thrombectomy.METHODS: Prospective, multicenter, open-label, core lab-adjudicated, two-arm study comparing safety and efficacy of a feasibility version of the RapidPulseTM system compared with contemporary controls. Primary endpoint was the rate of mTICI ≥ 2c after first-pass effect (FPE). Additional efficacy endpoints were the rates of mTICI ≥ 2b after first pass (modified FPE (mFPE)), last pass with study device defined as frontline technical success, and after all passes including rescue therapy. The primary safety endpoints included symptomatic ICH (sICH) within 24 h post-procedure.RESULTS: Between February 2022 to December 2022, 80 subjects were consented and enrolled in the study (n = 40 treatment arm, n = 40 control arm). In the intent to treat (ITT) population, mean age was 67.8 ± 11.5 years; 19 (47.5\%) were male. Median NIHSS score was 16 (IQR: 13-22). Median ASPECTS score was 9 (IQR: 8-10). The rate of mTICI ≥ 2c after first pass was 53.9\% in ITT population (60.0\% in per-protocol population) versus 38.5\% in the corresponding control population. Functional independence (mRS 0-2) at 90 days was achieved in 61.1\% (22/36) in the RapidPulseTM arm and 52.8\% (19/36) in the control arm. In the RapidPulseTM arm, no sICH within 24 h and no device-related morbidity or mortality occurred.CONCLUSION: Preliminary data suggests RapidPulseTM Aspiration System is highly effective and safe for recanalization of large vessel occlusions.",

keywords = "LVO, Stroke, cyclic aspiration, mechanical thrombectomy",

author = "Arsida Bajrami and Serdar Geyik and Ozgur Ertugrul and Eren Erdem and \{Gallego Leon\}, \{Jose I\} and Giorgio Barbieri and \{Dominguez Rodriguez\}, Carlos and Ray{\'o}n-Aledo, \{Jose Carlos\} and Barra, \{Antonio I Sagredo\} and Blanco, \{Fernando S Sanchez\} and Candel, \{Carmen Serna\} and Montalverne, \{Francisco Jose\} and Andrade, \{Lidemarcks I\} and Diego Bandeira and Jose Bezerra and Hellen Carm and Silva, \{Henrique Coelho\} and \{Braga Cruz Guedes de Morais\}, Alessandra and \{de Lucena\}, \{Adson Freitas\} and Lima, \{Fabricio O\} and George Mendes and Rocha, \{Felipe A\} and Karlis Kupcs and Helmuts Kidikas and Janis Vetra and Gyula Gal and Anabel Diaz and Nogueira, \{Raul G\}",

note = "Publisher Copyright: {\textcopyright} The Author(s) 2024.",

year = "2024",

month = mar,

day = "22",

doi = "10.1177/15910199241239094",

language = "English",

journal = "Interventional Neuroradiology",

issn = "1123-9344",

publisher = "SAGE Publications Inc.",

}

Bajrami, A, Geyik, S, Ertugrul, O, Erdem, E, Gallego Leon, JI, Barbieri, G, Dominguez Rodriguez, C, Rayón-Aledo, JC, Barra, AIS, Blanco, FSS, Candel, CS, Montalverne, FJ, Andrade, LI, Bandeira, D, Bezerra, J, Carm, H, Silva, HC, Braga Cruz Guedes de Morais, A, de Lucena, AF, Lima, FO, Mendes, G, Rocha, FA, Kupcs, K, Kidikas, H, Vetra, J, Gal, G, Diaz, A & Nogueira, RG 2024, 'RapidpulseTM cyclic aspiration system for acute ischemic stroke due to large vessel occlusions', Interventional Neuroradiology. https://doi.org/10.1177/15910199241239094

TY - JOUR

T1 - RapidpulseTM cyclic aspiration system for acute ischemic stroke due to large vessel occlusions

AU - Bajrami, Arsida

AU - Geyik, Serdar

AU - Ertugrul, Ozgur

AU - Erdem, Eren

AU - Gallego Leon, Jose I

AU - Barbieri, Giorgio

AU - Dominguez Rodriguez, Carlos

AU - Rayón-Aledo, Jose Carlos

AU - Barra, Antonio I Sagredo

AU - Blanco, Fernando S Sanchez

AU - Candel, Carmen Serna

AU - Montalverne, Francisco Jose

AU - Andrade, Lidemarcks I

AU - Bandeira, Diego

AU - Bezerra, Jose

AU - Carm, Hellen

AU - Silva, Henrique Coelho

AU - Braga Cruz Guedes de Morais, Alessandra

AU - de Lucena, Adson Freitas

AU - Lima, Fabricio O

AU - Mendes, George

AU - Rocha, Felipe A

AU - Kupcs, Karlis

AU - Kidikas, Helmuts

AU - Vetra, Janis

AU - Gal, Gyula

AU - Diaz, Anabel

AU - Nogueira, Raul G

PY - 2024/3/22

Y1 - 2024/3/22

N2 - BACKGROUND: The best strategy to achieve optimal reperfusion outcomes during mechanical thrombectomy remains to be defined. The RapidPulseTM Cyclic Aspiration System is a novel technology, delivering high-frequency pulsed vacuum forces to increase the efficiency of aspiration thrombectomy.METHODS: Prospective, multicenter, open-label, core lab-adjudicated, two-arm study comparing safety and efficacy of a feasibility version of the RapidPulseTM system compared with contemporary controls. Primary endpoint was the rate of mTICI ≥ 2c after first-pass effect (FPE). Additional efficacy endpoints were the rates of mTICI ≥ 2b after first pass (modified FPE (mFPE)), last pass with study device defined as frontline technical success, and after all passes including rescue therapy. The primary safety endpoints included symptomatic ICH (sICH) within 24 h post-procedure.RESULTS: Between February 2022 to December 2022, 80 subjects were consented and enrolled in the study (n = 40 treatment arm, n = 40 control arm). In the intent to treat (ITT) population, mean age was 67.8 ± 11.5 years; 19 (47.5%) were male. Median NIHSS score was 16 (IQR: 13-22). Median ASPECTS score was 9 (IQR: 8-10). The rate of mTICI ≥ 2c after first pass was 53.9% in ITT population (60.0% in per-protocol population) versus 38.5% in the corresponding control population. Functional independence (mRS 0-2) at 90 days was achieved in 61.1% (22/36) in the RapidPulseTM arm and 52.8% (19/36) in the control arm. In the RapidPulseTM arm, no sICH within 24 h and no device-related morbidity or mortality occurred.CONCLUSION: Preliminary data suggests RapidPulseTM Aspiration System is highly effective and safe for recanalization of large vessel occlusions.

AB - BACKGROUND: The best strategy to achieve optimal reperfusion outcomes during mechanical thrombectomy remains to be defined. The RapidPulseTM Cyclic Aspiration System is a novel technology, delivering high-frequency pulsed vacuum forces to increase the efficiency of aspiration thrombectomy.METHODS: Prospective, multicenter, open-label, core lab-adjudicated, two-arm study comparing safety and efficacy of a feasibility version of the RapidPulseTM system compared with contemporary controls. Primary endpoint was the rate of mTICI ≥ 2c after first-pass effect (FPE). Additional efficacy endpoints were the rates of mTICI ≥ 2b after first pass (modified FPE (mFPE)), last pass with study device defined as frontline technical success, and after all passes including rescue therapy. The primary safety endpoints included symptomatic ICH (sICH) within 24 h post-procedure.RESULTS: Between February 2022 to December 2022, 80 subjects were consented and enrolled in the study (n = 40 treatment arm, n = 40 control arm). In the intent to treat (ITT) population, mean age was 67.8 ± 11.5 years; 19 (47.5%) were male. Median NIHSS score was 16 (IQR: 13-22). Median ASPECTS score was 9 (IQR: 8-10). The rate of mTICI ≥ 2c after first pass was 53.9% in ITT population (60.0% in per-protocol population) versus 38.5% in the corresponding control population. Functional independence (mRS 0-2) at 90 days was achieved in 61.1% (22/36) in the RapidPulseTM arm and 52.8% (19/36) in the control arm. In the RapidPulseTM arm, no sICH within 24 h and no device-related morbidity or mortality occurred.CONCLUSION: Preliminary data suggests RapidPulseTM Aspiration System is highly effective and safe for recanalization of large vessel occlusions.

KW - LVO

KW - Stroke

KW - cyclic aspiration

KW - mechanical thrombectomy

UR - https://www.scopus.com/pages/publications/85188336582

U2 - 10.1177/15910199241239094

DO - 10.1177/15910199241239094

M3 - Article

C2 - 38515399

SN - 1123-9344

JO - Interventional Neuroradiology

JF - Interventional Neuroradiology

M1 - 15910199241239094

ER -

RapidpulseTM cyclic aspiration system for acute ischemic stroke due to large vessel occlusions

Abstract

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