An in vitro porcine model evaluating a novel stent retriever for thrombectomy of the common carotid artery

Catheter Cardiovasc Interv. 2016 Feb 15;87(3):457-64. doi: 10.1002/ccd.26285. Epub 2015 Oct 30.

Abstract

Objectives: This study aimed to test the safety and efficiency of a novel stent retriever, RECO, in a swine model.

Background: The stent retrievers show great benefit for patients with acute ischemic stroke.

Methods: The framework of the stent was optimized. The proximal stent was closed; mechanical connection replaced the electrolysis connection and the push wire located on the longitudinal axis. After tests in vitro, the safety and thrombectomy efficiency of RECO device were evaluated by angiography and histological analysis in a swine model with placement of experimental soft or hard thrombi.

Results: No device-related thrombi were observed on the perioperative term or 1 month later. The endothelial cells were intact and the smooth muscle cells did not migrate or proliferate. Device-related vasospasm was detected in 9% vessels undergoing the procedure and was alleviated after delivery of a dose of nitroglycerin. The RECO device demonstrated a high recanalization rate in the target vessels with a mean of 1.3 runs. No residual thrombi were observed under the DSA or microscope.

Conclusions: Our data indicated that RECO device was a novel, safe and effective stent based clot retriever. A phase IIa clinical trial, RESTORE, is undergoing (NCT01983644).

Keywords: RECO; mechanical thrombectomy; stent-like clot retriever; stroke.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Animals
  • Carotid Artery, Common* / diagnostic imaging
  • Carotid Artery, Common* / pathology
  • Carotid Stenosis / diagnostic imaging
  • Carotid Stenosis / therapy*
  • Device Removal / adverse effects
  • Device Removal / instrumentation*
  • Device Removal / methods
  • Disease Models, Animal
  • Prosthesis Design
  • Stents*
  • Swine
  • Thrombectomy / adverse effects
  • Thrombectomy / instrumentation*
  • Thrombectomy / methods
  • Thrombosis / diagnostic imaging
  • Thrombosis / surgery*
  • Time Factors

Associated data

  • ClinicalTrials.gov/NCT01983644