At a glance

ClinicalIndex Comparison Record

Phase 3Completed

Drug / intervention

Over-the-wire & Rapid Exchange ACCULINK (tm) Carotid Stent & ACCUNET (tm) embolic protection systemdevice

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00180518

NCT00180518Phase 3Completed

Compare CT.gov

Prospective, Non-Randomized, Multi-Center, Single-Arm Trial to Assess Safety & Efficacy of the Acculink Carotid Stent System With the Accunet Embolic Protection System in High-Risk Patients With Carotid Artery Lesions.

Abbott Medical Devices·interventional·Posted Sep 16, 2005·Updated Sep 12, 2008

In Brief

A Phase 3 clinical trial evaluating Over-the-wire & Rapid Exchange ACCULINK (tm) Carotid Stent & ACCUNET (tm) embolic protection system for Carotid Atherosclerosis and Carotid Artery Disease. Completed.

Detailed Summary

1. To evaluate the safety and efficacy of the over-the-wire (OTW) ACCULINK (tm) System in patients deemed to be either at high risk or unsuitable for carotid endarterectomy (CEA) 2. To evaluate the efficacy of the OTW ACCUNET System in patients deemed to be either at high risk or unsuitable for carotid endarterectomy (CEA). 3. To demonstrate equivalence in the safety and performance of the RX ACCULINK Carotid Stent System and RX ACCUNET Embolic Protection System and the corresponding OTW devices.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsCarotid Atherosclerosis, Carotid Artery Disease

Countries--

Collaborators--

Timeline

Phase 3CompletedFinished

2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartMay 2000

Primary CompletionOct 2003

Study CompletionNov 2003

First PostedSep 2005

TodayJul 2026

First PostedSep 16, 2005

Enrollment StartMay 1, 2000

Primary CompletionOct 1, 2003

Study CompletionNov 1, 2003

TodayJul 2, 2026

Enrollment to primary: 3.4 yearsPosted 20.8 years ago

Interventions

Over-the-wire & Rapid Exchange ACCULINK (tm) Carotid Stent & ACCUNET (tm) embolic protection systemdevice

Two rapid exchange devices will be evaluated: the RX ACCUNET Embolic Protection System ("RX ACCUNET") and the RX ACCULINK Carotid Stent System ("RX ACCULINK"). The RX ACCUNET Embolic Protection System is intended to facilitate the placement of diagnostic and therapeutic devices during interventional procedures and to capture embolic material that may be present during carotid artery interventional procedures. The RX ACCULINK™ Carotid Stent System is intended for the treatment of carotid artery stenosis in the internal carotid artery (ICA), with or without involvement of the contiguous common carotid artery (CCA), in asymptomatic patients and symptomatic patients.