Evaluation of the TriActiv ProGuard System During Carotid Artery Stenting

Protection During Carotid Stenting in High Risk Patients With the TriActiv ProGuard System

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.

Study Overview

• Status: Terminated
• Conditions: Carotid Stenosis
• Intervention / Treatment: Device: Carotid Stent Implantation; Device: Embolic Protection

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.

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Germany
  • Bayern, Germany, 81737
    • Stadtisches Krankenhaus Neuperlach
  • Frankfurt, Germany, 60389
    • CardioVasculares Centrum Frankfurt Sankt Katharinen
  • Hamburg, Germany, 22527
    • Herzzentrum Hamburg
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294-0012
      • University of Alabama Birmingham
    • Fairhope, Alabama, United States, 36532
      • Thomas Hospital
  • California
    • Beverly Hills, California, United States, 90210
      • Brotman Medical Center
    • Los Angeles, California, United States, 90017
      • Good Samaritan Hospital
    • Mountain View, California, United States, 94040
      • El Camino Hospital
    • Stanford, California, United States, 94305
      • Stanford University Medical Center
  • Florida
    • Atlantis, Florida, United States, 33462
      • Florida Crdiovascular Research at JFK Medical Center
    • Jacksonville, Florida, United States, 32209
      • University of Florida
    • Miami, Florida, United States, 33176
      • Baptist Hospital of Miami
    • Miami Beach, Florida, United States, 33140
      • Mt. Sinai Medical Center
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
    • Atlanta, Georgia, United States, 30309
      • Piedmont Hospital
    • Atlanta, Georgia, United States, 30322
      • Crawford Long Hospital
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Jewish Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
  • New York
    • Buffalo, New York, United States, 14209
      • Millard Fillmore Hospital
    • Buffalo, New York, United States, 14209
      • Millard Fillmore
    • Manhasset, New York, United States, 11030
      • North Shore University Hospital
    • New York, New York, United States, 10021
      • Lenox Hill Hospital
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Forsyth Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Elyria, Ohio, United States, 44035
      • Lorain Community Hospital
    • Westlake, Ohio, United States, 44145
      • St. John West Shore Hospital
  • Pennsylvania
    • Harrisburg, Pennsylvania, United States, 17110
      • Pinnacle Health Hospital
    • Wyomissing, Pennsylvania, United States, 19610
      • St. Joseph Medical Center
  • South Carolina
    • Columbia, South Carolina, United States, 29204
      • Sisters of Charity Providence Hospital
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Methodist Germantown
    • Kingsport, Tennessee, United States, 37660
      • Wellmont Holston Valley Medical Center
    • Knoxville, Tennessee, United States, 37920
      • Baptist Hospital of East Tennessee
  • Utah
    • Salt Lake City, Utah, United States, 84143
      • LDS Hospital
  • Virginia
    • Richmond, Virginia, United States, 23226
      • Virginia Cardiovascular Specialists/St. Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Study Completion (Actual): June 1, 2007

Study Registration Dates

• First Submitted: November 1, 2006
• First Submitted That Met QC Criteria: November 1, 2006
• First Posted (Estimate): November 3, 2006

Study Record Updates

• Last Update Posted (Estimate): July 25, 2007
• Last Update Submitted That Met QC Criteria: July 20, 2007
• Last Verified: July 1, 2007

More Information

Terms related to this study

• Keywords: Carotid stenosis; Embolic protection; Carotid artery; Intracranial Embolism; Carotid stent; TriActiv ProGuard System; Carotid angioplasty
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Carotid Artery Diseases; Carotid Stenosis
• Other Study ID Numbers: PROGUARD