TY - JOUR

T1 - Clinical Results and Mechanical Properties of the Carotid CGUARD Double-Layered Embolic Prevention Stent

AU - Wissgott, Christian

AU - Schmidt, Wolfram

AU - Brandt-Wunderlich, Christoph

AU - Behrens, Peter

AU - Andresen, Reimer

N1 - Publisher Copyright: © The Author(s) 2016. Copyright: Copyright 2021 Elsevier B.V., All rights reserved.

PY - 2017/2

Y1 - 2017/2

N2 - PURPOSE: To report early clinical outcomes with a novel double-layer stent for the internal carotid artery (ICA) and the in vitro investigation of the stent's mechanical properties.METHODS: A prospective single-center study enrolled 30 consecutive patients (mean age 73.1±6.3 years; 21 men) with symptomatic (n=25) or high-grade (n=5) ICA stenosis treated with the new double-layer carotid CGUARD Embolic Prevention System (EPS) stent, which has an inner open-cell nitinol design with an outer closed-cell polyethylene terephthalate layer. The average stenosis of the treated arteries was 84.1%±7.9% with a mean lesion length of 16.6±2.1 mm. In the laboratory, 8×40-mm stents where tested in vitro with respect to their radial force during expansion, the bending stiffness of the stent system and the expanded stent, as well as the collapse pressure in a thin and flexible sheath. The wall adaptation was assessed using fluoroscopy after stent release in step and curved vessel models.RESULTS: The stent was successfully implanted in all patients. No peri- or postprocedural complications occurred; no minor or major stroke was observed in the 6-month follow-up. The bending stiffness of the expanded stent was 63.1 N·mm2 and (not unexpectedly) was clearly lower than that of the stent system (601.5 N·mm2). The normalized radial force during expansion of the stent to 7.0 mm, consistent with in vivo sizing, was relatively high (0.056 N/mm), which correlates well with the collapse pressure of 0.17 bars. Vessel wall adaptation was harmonic and caused no straightening of the vessel after clinical application.CONCLUSION: Because of its structure, the novel CGUARD EPS stent is characterized by a high flexibility combined with a high radial force and very good plaque coverage. These first clinical results demonstrate a very safe implantation behavior without any stroke up to 6 months after the procedure.

AB - PURPOSE: To report early clinical outcomes with a novel double-layer stent for the internal carotid artery (ICA) and the in vitro investigation of the stent's mechanical properties.METHODS: A prospective single-center study enrolled 30 consecutive patients (mean age 73.1±6.3 years; 21 men) with symptomatic (n=25) or high-grade (n=5) ICA stenosis treated with the new double-layer carotid CGUARD Embolic Prevention System (EPS) stent, which has an inner open-cell nitinol design with an outer closed-cell polyethylene terephthalate layer. The average stenosis of the treated arteries was 84.1%±7.9% with a mean lesion length of 16.6±2.1 mm. In the laboratory, 8×40-mm stents where tested in vitro with respect to their radial force during expansion, the bending stiffness of the stent system and the expanded stent, as well as the collapse pressure in a thin and flexible sheath. The wall adaptation was assessed using fluoroscopy after stent release in step and curved vessel models.RESULTS: The stent was successfully implanted in all patients. No peri- or postprocedural complications occurred; no minor or major stroke was observed in the 6-month follow-up. The bending stiffness of the expanded stent was 63.1 N·mm2 and (not unexpectedly) was clearly lower than that of the stent system (601.5 N·mm2). The normalized radial force during expansion of the stent to 7.0 mm, consistent with in vivo sizing, was relatively high (0.056 N/mm), which correlates well with the collapse pressure of 0.17 bars. Vessel wall adaptation was harmonic and caused no straightening of the vessel after clinical application.CONCLUSION: Because of its structure, the novel CGUARD EPS stent is characterized by a high flexibility combined with a high radial force and very good plaque coverage. These first clinical results demonstrate a very safe implantation behavior without any stroke up to 6 months after the procedure.

KW - Aged

KW - Angiography, Digital Subtraction

KW - Angioplasty, Balloon/adverse effects

KW - Carotid Artery, Internal/diagnostic imaging

KW - Carotid Stenosis/diagnostic imaging

KW - Embolic Protection Devices

KW - Female

KW - Germany

KW - Humans

KW - Male

KW - Materials Testing

KW - Prospective Studies

KW - Prosthesis Design

KW - Prosthesis Failure

KW - Severity of Illness Index

KW - Stents

KW - Time Factors

KW - Treatment Outcome

KW - open-cell design

KW - stenosis

KW - mechanical behavior

KW - radial force

KW - internal carotid artery

KW - closed-cell design

KW - stent

KW - embolic filter

KW - in vitro testing

KW - double-layer stent

KW - nitinol

KW - carotid artery stent

UR - http://www.scopus.com/inward/record.url?scp=85011579306&partnerID=8YFLogxK

U2 - 10.1177/1526602816671134

DO - 10.1177/1526602816671134

M3 - Article

C2 - 27733689

VL - 24

SP - 130

EP - 137

JO - Journal of Endovascular Therapy

JF - Journal of Endovascular Therapy

SN - 1526-6028

IS - 1

ER -