| Effectiveness and safety of the Proxis system in demonstrating retrograde coronary blood flow during proximal occlusion and in capturing embolic material. | |
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MedLine Citation:
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PMID: 15518607 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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The Feasibility And Safety Trial for its embolic protection device during transluminal intervention in coronary vessels: a European Registry (FASTER) was designed to demonstrate that (1) the Proxis embolic protection system can control anterograde flow and reverse blood flow in native coronary arteries and saphenous vein grafts; and (2) this system can capture embolic debris. Percutaneous coronary intervention on stenotic coronary lesions revolutionized treatment of coronary disease, but is associated with the risk of major adverse cardiac events. This prospective, nonrandomized, multicenter clinical feasibility and safety study enrolled 40 patients with 51 lesions at 4 centers who underwent treatment of stenotic lesions with proximal emboli protection (Proxis system). Proxis was successfully used 95% of the time, and embolic debris was qualitatively identified in all cases. Major adverse cardiac events occurred in 2 patients (5.0%): 1 late in-stent thrombosis resulting in death and 1 non-Q-wave infarction when a lesion was crossed before deployment of the Proxis system. Mean vessel occlusion time was 4.3 +/- 2.4 minutes. Native flow reversal was sufficient in 31 patients, with a mean aspirate volume of 11.8 +/- 6.5 ml. When the infusion catheter was used to augment reflow, mean occlusion time was 4.6 minutes. In conclusion, this trial is the first to demonstrate that retrograde blood flow can be achieved during proximal occlusion and that the Proxis system can be used safely during intervention of saphenous vein grafts and native coronary arterial lesions to capture embolic material. |
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Authors:
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Horst Sievert; Dennis W Wahr; Gerhard Schuler; Joachim J Schofer; Gabor Sutsch; Jim Pavliska; Marijke Skowasch |
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Publication Detail:
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Type: Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: The American journal of cardiology Volume: 94 ISSN: 0002-9149 ISO Abbreviation: Am. J. Cardiol. Publication Date: 2004 Nov |
Date Detail:
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Created Date: 2004-11-02 Completed Date: 2005-01-25 Revised Date: 2006-11-15 |
Medline Journal Info:
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Nlm Unique ID: 0207277 Medline TA: Am J Cardiol Country: United States |
Other Details:
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Languages: eng Pagination: 1134-9 Citation Subset: AIM; IM |
Affiliation:
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CardioVascuLar Center Frankfurt, Sankt Katharinen, Frankfurt, Germany. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Aged Aged, 80 and over Angioplasty, Transluminal, Percutaneous Coronary Balloon Occlusion* Biological Markers / blood Coronary Circulation / physiology* Coronary Disease / physiopathology*, therapy* Creatine Kinase / blood Creatine Kinase, MB Form Device Removal Embolism / physiopathology*, therapy* Equipment Safety Europe / epidemiology Female Humans Isoenzymes / blood Male Middle Aged Postoperative Complications / etiology, mortality Prospective Studies Survival Analysis Time Factors Treatment Outcome |
| Chemical | |
Reg. No./Substance:
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0/Biological Markers; 0/Isoenzymes; EC 2.7.3.2/Creatine Kinase; EC 2.7.3.2/Creatine Kinase, MB Form |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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