NCT00812383

Carotid With Bivalirudin Angioplasty

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 299 (actual)
• Sponsor: Medstar Health Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Single center randomized clinical trial, to evaluate the safety and efficacy of carotid artery stenting using the RX ACCULINK™ Carotid Stent System with RX ACCUNET™ Embolic Protection System or PercuSurge GuardWire® 3-6 Temporary Occlusion and Aspiration System using Angiomax (bivalirudin)versus heparin as the anticoagulant for treatment of occlusive carotid artery disease in low and high risk patient cohorts.

Conditions

• Carotid Artery Disease

Interventions

Type	Name	Description
DEVICE	RX ACCULINK™ Carotid Stent System; RX ACCUNET™ Embolic Protection System; PercuSurge GuardWire® 3-6 Temporary Occlusion and Aspiration System	Angiomax (bivalirudin) versus standard anticoagulation with heparin during carotid artery stenting with distal protection clinical endpoint evaluation

Timeline

• Start date: 2003-08-01
• Primary completion: 2019-07-01
• Completion: 2019-12-01
• First posted: 2008-12-22
• Last updated: 2020-10-28

Locations

1 site across 1 country: United States