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Safety and Efficacy of Gadofosveset-Enhanced MR Angiography for Evaluation of Pedal Arterial Disease: Multicenter Comparative Phase 3 Study

Enrique Bosch1, Karl-Friedrich Kreitner2, Mario Fava Peirano3, Siegfried Thurner4, Kohkan Shamsi5,6 and Edward C. Parsons, Jr.7

1 Hospital Clinica Alemana, Santiago, Chile.
2 Klinik und Poliklinik fur Radiologie der Johannes-Gutenberg-Universität Mainz, Mainz, Germany.
3 Hospital Clinico de la Universidad Catolica, Servicio Radiologia, Santiago, Chile.
4 Krankenhaus der Barmherziegen Bruder, Universität Wien, Vienna, Austria.
5 Bayer HealthCare, Montville, New Jersey, 07045.
6 Present address: Symbiotic Pharma Research, Pine Brook, NJ.
7 EPIX Pharmaceuticals, 4 Maguire Rd., Lexington, MA 02421.


Figure 1
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  		Fig. 1A —Receiver operating characteristic (ROC) curves. Open triangles indicate reader A, unenhanced images; solid triangles, reader A, contrast-enhanced images; open squares, reader B, unenhanced images; solid squares, reader B, contrast-enhanced images; open circles, reader C, unenhanced images; solid circles, reader C, contrast-enhanced images. Graph shows ROC curves for 0.03-mmol/kg dose group.

 

Figure 2
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  		Fig. 1B —Receiver operating characteristic (ROC) curves. Open triangles indicate reader A, unenhanced images; solid triangles, reader A, contrast-enhanced images; open squares, reader B, unenhanced images; solid squares, reader B, contrast-enhanced images; open circles, reader C, unenhanced images; solid circles, reader C, contrast-enhanced images. Graph shows ROC curves for 0.05-mmol/kg dose group.

 

Figure 3
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  		Fig. 2A —49-year-old man with left-sided claudication and gangrenous left great toe. Angiogram (A) and maximum intensity projections from unenhanced 2D time-of-flight MR angiogram (B) and gadofosveset-enhanced MR angiograms in dynamic (C) and steady (D) states show comparable findings.

 

Figure 4
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  		Fig. 2B —49-year-old man with left-sided claudication and gangrenous left great toe. Angiogram (A) and maximum intensity projections from unenhanced 2D time-of-flight MR angiogram (B) and gadofosveset-enhanced MR angiograms in dynamic (C) and steady (D) states show comparable findings.

 

Figure 5
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  		Fig. 2C —49-year-old man with left-sided claudication and gangrenous left great toe. Angiogram (A) and maximum intensity projections from unenhanced 2D time-of-flight MR angiogram (B) and gadofosveset-enhanced MR angiograms in dynamic (C) and steady (D) states show comparable findings.

 

Figure 6
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  		Fig. 2D —49-year-old man with left-sided claudication and gangrenous left great toe. Angiogram (A) and maximum intensity projections from unenhanced 2D time-of-flight MR angiogram (B) and gadofosveset-enhanced MR angiograms in dynamic (C) and steady (D) states show comparable findings.

 

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