NCT01075217

Isovue in Peripheral Digital Subtraction Angiography (DSA)

A Phase IV Multi-Center Study to Compare ISOVUE -250 and VISIPAQUE 270 for Motion Artifact and Pain in Peripheral Digital Subtraction Angiography (DSA)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 174 (actual)
• Sponsor: Bracco Diagnostics, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

No significant differences is expected in observed motion artifacts, heat or pain reported during peripheral DSA performed for diagnostic and/or endovascular therapeutic purposes.

Conditions

• Peripheral Arterial Occlusive Disease

Interventions

Type	Name	Description
DRUG	iopamidol	Participants received at least one intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
DRUG	iodixanol	Participants received at least one intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).

Timeline

• Start date: 2010-04-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2010-02-25
• Last updated: 2013-05-30
• Results posted: 2013-05-23

Locations

1 site across 1 country: United States