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Evaluation of the TriActiv ProGuard System During Carotid Artery Stenting

This study has been terminated.
(Sponsor elected to not pursue this indication for the study device.)
Sponsor:
Information provided by:
Kensey Nash Corporation
ClinicalTrials.gov Identifier:
NCT00395785
First received: November 1, 2006
Last updated: July 20, 2007
Last verified: July 2007
History of Changes
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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 34 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

ClinicalTrials.gov Identifier: NCT00395785     History of Changes
Other Study ID Numbers: PROGUARD
Study First Received: November 1, 2006
Last Updated: July 20, 2007
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

Additional relevant MeSH terms:
Carotid Stenosis
Constriction, Pathologic
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 16, 2013