Details
| Original language | English |
|---|---|
| Pages (from-to) | 130-137 |
| Number of pages | 8 |
| Journal | Journal of Endovascular Therapy |
| Volume | 24 |
| Issue number | 1 |
| Publication status | Published - Feb 2017 |
| Externally published | Yes |
Abstract
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.
Keywords
- Aged, Angiography, Digital Subtraction, Angioplasty, Balloon/adverse effects, Carotid Artery, Internal/diagnostic imaging, Carotid Stenosis/diagnostic imaging, Embolic Protection Devices, Female, Germany, Humans, Male, Materials Testing, Prospective Studies, Prosthesis Design, Prosthesis Failure, Severity of Illness Index, Stents, Time Factors, Treatment Outcome, open-cell design, stenosis, mechanical behavior, radial force, internal carotid artery, closed-cell design, stent, embolic filter, in vitro testing, double-layer stent, nitinol, carotid artery stent
ASJC Scopus subject areas
- Medicine(all)
- Cardiology and Cardiovascular Medicine
- Medicine(all)
- Radiology Nuclear Medicine and imaging
- Medicine(all)
- Surgery
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In: Journal of Endovascular Therapy, Vol. 24, No. 1, 02.2017, p. 130-137.
Research output: Contribution to journal › Article › Research
}
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 -