Evaluation of the TriActiv ProGuard System During Carotid Artery Stenting - Full Text View

Sponsored by:	Kensey Nash Corporation
Information provided by:	Kensey Nash Corporation
ClinicalTrials.gov Identifier:	NCT00395785

Purpose

The purpose of this study is to evaluate the safety and efficacy of the TriActiv® ProGuard™ System when used during a stent placement in a blockage within the carotid artery in patients considered to be at high risk for complications from surgical endarterectomy.

Condition	Intervention	Phase
Carotid Stenosis	Device: Carotid Stent Implantation Device: Embolic Protection	Phase II Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Protection During Carotid Stenting in High Risk Patients With the TriActiv ProGuard System

Further study details as provided by Kensey Nash Corporation:

Primary Outcome Measures:

A composite of major adverse events including any death, any stroke and/or myocardial infarction through thirty days post-procedure.

Secondary Outcome Measures:

Rate of subject intolerance to prolonged carotid artery occlusion;
Rate of access site complications requiring treatment with blood transfusion or surgical repair.
Rate of successful use of the study device success
Rate of successful lesion treatment
Rate of procedure success

Estimated Enrollment:	400
Study Start Date:	November 2006
Study Completion Date:	June 2007

Detailed Description:

Patients with certain anatomic or medical conditions have a greater risk of serious complications following carotid endarterectomy (a surgical procedure that removes blockages in the carotid artery). Recently, these patients have been treated effectively with the implantation of a carotid stent (a metallic mesh tube). When implanting the carotid stent, physicians use devices called embolic protection devices to prevent particles from the blockage from flowing up to the brain. The TriActiv® ProGuard™ System is an embolic protection device that uses a small balloon to temporarily stop blood flow within the diseased carotid artery while the stent is implanted. Then, the TriActiv® ProGuard™ System removes any particles that may have been released from the blockage during stent implantation before blood flow is restored. This study will evaluate the safety and efficacy of the TriActiv® ProGuard™ System during carotid stent placement in patients who are considered to be at a high risk for complications from surgical endarterectomy.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Greater than 18 year of age
Patient gives informed consent
Less than 30mm stenosis in the common and/or internal carotid artery: at least a 50% stenosis if symptomatic or at least an 80% stenosis if asymptomatic
At least one medical or anatomic condition which makes the patient a high surgical risk.

Exclusion Criteria:

Stroke within 14 days
Major stroke with significant residual effects
Myocardial infarction within 72 hours
Extensive atherosclerotic disease in the aortic arch or proximal common carotid artery
Severe carotid artery tortuosity
Total occlusion
Presence of thrombus or heavy calcification in the carotid artery
Pre-existing carotid artery dissection
Any planned interventional or surgical procedures within 30 days
Atrial fibrillation
Creatinine > 2 mg/dL
Current participation in another investigational drug or device study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00395785

Show 35 Study Locations

Sponsors and Collaborators

Kensey Nash Corporation

Investigators

Principal Investigator:	Gary S Roubin, MD	Lenox Hill Hospital, New York, NY
Principal Investigator:	Rajesh Dave, MD	Pinnacle Health Hospital, Harrisburg, PA

More Information

No publications provided

Study ID Numbers:	PROGUARD
Study First Received:	November 1, 2006
Last Updated:	July 20, 2007
ClinicalTrials.gov Identifier:	NCT00395785 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Kensey Nash Corporation:

Carotid stenosis
Intracranial Embolism
Carotid artery
Carotid stent

Embolic protection
TriActiv ProGuard System
Carotid angioplasty

Study placed in the following topic categories:

Arterial Occlusive Diseases
Carotid Stenosis
Embolism
Vascular Diseases
Central Nervous System Diseases

Constriction, Pathologic
Intracranial Embolism
Brain Diseases
Carotid Artery Diseases
Cerebrovascular Disorders

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Carotid Stenosis
Nervous System Diseases
Vascular Diseases
Central Nervous System Diseases

Cardiovascular Diseases
Brain Diseases
Carotid Artery Diseases
Cerebrovascular Disorders

ClinicalTrials.gov processed this record on May 07, 2009