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Carotid With Bivalirudin Angioplasty

NCT00812383 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 299

Last updated 2020-10-28

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Medstar Health Research Institute

    lead OTHER

Principal Investigators

  • Lowell Satler, MD · Medstar Health Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-08-31
Primary Completion
2019-07-31
Completion
2019-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00812383 on ClinicalTrials.gov