Preliminary Clinical Results and Mechanical Behavior of a New Double-Layer Carotid Stent

Christian Wissgott; Wolfram Schmidt; Christoph Brandt; Peter Behrens; Reimer Andresen

doi:10.1177/1526602815593490

Details

Original language	English
Pages (from-to)	634-639
Number of pages	6
Journal	Journal of Endovascular Therapy
Volume	22
Issue number	4
Publication status	Published - 1 Aug 2015
Externally published	Yes

Abstract

PURPOSE: To evaluate the in vitro mechanical and clinical implant behavior of a next-generation double-layer stent designed for the carotid artery.

METHODS: The new double-layer CASPER-RX stent was implanted in 12 patients (median age 69 years; 8 men) with high-grade symptomatic internal carotid artery stenoses (mean 82%). In the in vitro experiments, the CASPER-RX stent (8-×40-mm model) was investigated with respect to its radial force on expansion and the bending stiffness of the stent system and of the stent in its expanded state, as well as the collapse pressure in a thin, flexible sleeve. The wall adaptation of the expanded stents was assessed by fluoroscopy after release in a step and curve model.

RESULTS: Technical success was achieved in all patients without complications; there was no peri- or postinterventional stroke and no stroke or restenosis after 6 months. In the experimental studies, the bending stiffness of the stent on the delivery system (154.9 N mm(2)) was significantly lower than when expanded in a 7-mm flexible tube (467.4 N mm(2)). The radial force on expansion of the stent to 7 mm was low (0.011 N/mm). The collapse pressure was relatively high (0.56 bar) as a result of the stent's particular stent structure. The stent exhibited significant foreshortening of 27.6%. The conformability to the wall in the step model was relatively smooth; in the curve model, straightening occurred with consecutive slight stenosis.

CONCLUSION: The first clinical results showed a safe implantation behavior without the occurrence of any ischemia. The structure of the new CASPER-RX stent creates an acceptable flexibility, low radial force, and high collapse pressure. The large foreshortening during implantation should be considered as well as the higher bending stiffness, especially when used in elongated carotid arteries.

Keywords

Aged, Carotid Stenosis/surgery, Female, Humans, Male, Prosthesis Design, Stents, Stress, Mechanical, Treatment Outcome, Mechanical behavior, Stenosis, Foreshortening, In vitro testing, Stent, Closed-cell design, Bending stiffness, Ischemia, Radial force, Carotid artery, Collapse pressure

ASJC Scopus subject areas

Medicine(all)
Cardiology and Cardiovascular Medicine
Medicine(all)
Radiology Nuclear Medicine and imaging
Medicine(all)
Surgery

Cite this

Preliminary Clinical Results and Mechanical Behavior of a New Double-Layer Carotid Stent. / Wissgott, Christian; Schmidt, Wolfram; Brandt, Christoph et al.
In: Journal of Endovascular Therapy, Vol. 22, No. 4, 01.08.2015, p. 634-639.

Research output: Contribution to journal › Article › Research

Wissgott, C, Schmidt, W, Brandt, C, Behrens, P & Andresen, R 2015, 'Preliminary Clinical Results and Mechanical Behavior of a New Double-Layer Carotid Stent', Journal of Endovascular Therapy, vol. 22, no. 4, pp. 634-639. https://doi.org/10.1177/1526602815593490

Wissgott, C., Schmidt, W., Brandt, C., Behrens, P., & Andresen, R. (2015). Preliminary Clinical Results and Mechanical Behavior of a New Double-Layer Carotid Stent. Journal of Endovascular Therapy, 22(4), 634-639. https://doi.org/10.1177/1526602815593490

Wissgott C, Schmidt W, Brandt C, Behrens P, Andresen R. Preliminary Clinical Results and Mechanical Behavior of a New Double-Layer Carotid Stent. Journal of Endovascular Therapy. 2015 Aug 1;22(4):634-639. doi: 10.1177/1526602815593490

Wissgott, Christian ; Schmidt, Wolfram ; Brandt, Christoph et al. / Preliminary Clinical Results and Mechanical Behavior of a New Double-Layer Carotid Stent. In: Journal of Endovascular Therapy. 2015 ; Vol. 22, No. 4. pp. 634-639.

Download

@article{bf72458830674115aee7078880ef8989,

title = "Preliminary Clinical Results and Mechanical Behavior of a New Double-Layer Carotid Stent",

abstract = "PURPOSE: To evaluate the in vitro mechanical and clinical implant behavior of a next-generation double-layer stent designed for the carotid artery.METHODS: The new double-layer CASPER-RX stent was implanted in 12 patients (median age 69 years; 8 men) with high-grade symptomatic internal carotid artery stenoses (mean 82%). In the in vitro experiments, the CASPER-RX stent (8-×40-mm model) was investigated with respect to its radial force on expansion and the bending stiffness of the stent system and of the stent in its expanded state, as well as the collapse pressure in a thin, flexible sleeve. The wall adaptation of the expanded stents was assessed by fluoroscopy after release in a step and curve model.RESULTS: Technical success was achieved in all patients without complications; there was no peri- or postinterventional stroke and no stroke or restenosis after 6 months. In the experimental studies, the bending stiffness of the stent on the delivery system (154.9 N mm(2)) was significantly lower than when expanded in a 7-mm flexible tube (467.4 N mm(2)). The radial force on expansion of the stent to 7 mm was low (0.011 N/mm). The collapse pressure was relatively high (0.56 bar) as a result of the stent's particular stent structure. The stent exhibited significant foreshortening of 27.6%. The conformability to the wall in the step model was relatively smooth; in the curve model, straightening occurred with consecutive slight stenosis.CONCLUSION: The first clinical results showed a safe implantation behavior without the occurrence of any ischemia. The structure of the new CASPER-RX stent creates an acceptable flexibility, low radial force, and high collapse pressure. The large foreshortening during implantation should be considered as well as the higher bending stiffness, especially when used in elongated carotid arteries.",

keywords = "Aged, Carotid Stenosis/surgery, Female, Humans, Male, Prosthesis Design, Stents, Stress, Mechanical, Treatment Outcome, Mechanical behavior, Stenosis, Foreshortening, In vitro testing, Stent, Closed-cell design, Bending stiffness, Ischemia, Radial force, Carotid artery, Collapse pressure",

author = "Christian Wissgott and Wolfram Schmidt and Christoph Brandt and Peter Behrens and Reimer Andresen",

year = "2015",

month = aug,

day = "1",

doi = "10.1177/1526602815593490",

language = "English",

volume = "22",

pages = "634--639",

journal = "Journal of Endovascular Therapy",

issn = "1526-6028",

publisher = "SAGE Publications Inc.",

number = "4",

}

Download

TY - JOUR

T1 - Preliminary Clinical Results and Mechanical Behavior of a New Double-Layer Carotid Stent

AU - Wissgott, Christian

AU - Schmidt, Wolfram

AU - Brandt, Christoph

AU - Behrens, Peter

AU - Andresen, Reimer

PY - 2015/8/1

Y1 - 2015/8/1

N2 - PURPOSE: To evaluate the in vitro mechanical and clinical implant behavior of a next-generation double-layer stent designed for the carotid artery.METHODS: The new double-layer CASPER-RX stent was implanted in 12 patients (median age 69 years; 8 men) with high-grade symptomatic internal carotid artery stenoses (mean 82%). In the in vitro experiments, the CASPER-RX stent (8-×40-mm model) was investigated with respect to its radial force on expansion and the bending stiffness of the stent system and of the stent in its expanded state, as well as the collapse pressure in a thin, flexible sleeve. The wall adaptation of the expanded stents was assessed by fluoroscopy after release in a step and curve model.RESULTS: Technical success was achieved in all patients without complications; there was no peri- or postinterventional stroke and no stroke or restenosis after 6 months. In the experimental studies, the bending stiffness of the stent on the delivery system (154.9 N mm(2)) was significantly lower than when expanded in a 7-mm flexible tube (467.4 N mm(2)). The radial force on expansion of the stent to 7 mm was low (0.011 N/mm). The collapse pressure was relatively high (0.56 bar) as a result of the stent's particular stent structure. The stent exhibited significant foreshortening of 27.6%. The conformability to the wall in the step model was relatively smooth; in the curve model, straightening occurred with consecutive slight stenosis.CONCLUSION: The first clinical results showed a safe implantation behavior without the occurrence of any ischemia. The structure of the new CASPER-RX stent creates an acceptable flexibility, low radial force, and high collapse pressure. The large foreshortening during implantation should be considered as well as the higher bending stiffness, especially when used in elongated carotid arteries.

AB - PURPOSE: To evaluate the in vitro mechanical and clinical implant behavior of a next-generation double-layer stent designed for the carotid artery.METHODS: The new double-layer CASPER-RX stent was implanted in 12 patients (median age 69 years; 8 men) with high-grade symptomatic internal carotid artery stenoses (mean 82%). In the in vitro experiments, the CASPER-RX stent (8-×40-mm model) was investigated with respect to its radial force on expansion and the bending stiffness of the stent system and of the stent in its expanded state, as well as the collapse pressure in a thin, flexible sleeve. The wall adaptation of the expanded stents was assessed by fluoroscopy after release in a step and curve model.RESULTS: Technical success was achieved in all patients without complications; there was no peri- or postinterventional stroke and no stroke or restenosis after 6 months. In the experimental studies, the bending stiffness of the stent on the delivery system (154.9 N mm(2)) was significantly lower than when expanded in a 7-mm flexible tube (467.4 N mm(2)). The radial force on expansion of the stent to 7 mm was low (0.011 N/mm). The collapse pressure was relatively high (0.56 bar) as a result of the stent's particular stent structure. The stent exhibited significant foreshortening of 27.6%. The conformability to the wall in the step model was relatively smooth; in the curve model, straightening occurred with consecutive slight stenosis.CONCLUSION: The first clinical results showed a safe implantation behavior without the occurrence of any ischemia. The structure of the new CASPER-RX stent creates an acceptable flexibility, low radial force, and high collapse pressure. The large foreshortening during implantation should be considered as well as the higher bending stiffness, especially when used in elongated carotid arteries.

KW - Aged

KW - Carotid Stenosis/surgery

KW - Female

KW - Humans

KW - Male

KW - Prosthesis Design

KW - Stents

KW - Stress, Mechanical

KW - Treatment Outcome

KW - Mechanical behavior

KW - Stenosis

KW - Foreshortening

KW - In vitro testing

KW - Stent

KW - Closed-cell design

KW - Bending stiffness

KW - Ischemia

KW - Radial force

KW - Carotid artery

KW - Collapse pressure

UR - http://www.scopus.com/inward/record.url?scp=84940195003&partnerID=8YFLogxK

U2 - 10.1177/1526602815593490

DO - 10.1177/1526602815593490

M3 - Article

C2 - 26187981

VL - 22

SP - 634

EP - 639

JO - Journal of Endovascular Therapy

JF - Journal of Endovascular Therapy

SN - 1526-6028

IS - 4

ER -

Research@Leibniz University