Document Detail

Effectiveness and safety of the Proxis system in demonstrating retrograde coronary blood flow during proximal occlusion and in capturing embolic material.
MedLine Citation:
PMID:  15518607     Owner:  NLM     Status:  MEDLINE    
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.
Horst Sievert; Dennis W Wahr; Gerhard Schuler; Joachim J Schofer; Gabor Sutsch; Jim Pavliska; Marijke Skowasch
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  The American journal of cardiology     Volume:  94     ISSN:  0002-9149     ISO Abbreviation:  Am. J. Cardiol.     Publication Date:  2004 Nov 
Date Detail:
Created Date:  2004-11-02     Completed Date:  2005-01-25     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  0207277     Medline TA:  Am J Cardiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1134-9     Citation Subset:  AIM; IM    
CardioVascuLar Center Frankfurt, Sankt Katharinen, Frankfurt, Germany.
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MeSH Terms
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
Isoenzymes / blood
Middle Aged
Postoperative Complications / etiology,  mortality
Prospective Studies
Survival Analysis
Time Factors
Treatment Outcome
Reg. No./Substance:
0/Biological Markers; 0/Isoenzymes; EC Kinase; EC Kinase, MB Form

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