search
Back to results

Evaluation of the TriActiv ProGuard System During Carotid Artery Stenting

Primary Purpose

Carotid Stenosis

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Carotid Stent Implantation
Embolic Protection
Sponsored by
Kensey Nash Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carotid Stenosis focused on measuring Carotid stenosis, Intracranial Embolism, Carotid artery, Carotid stent, Embolic protection, TriActiv ProGuard System, Carotid angioplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama Birmingham
  • Thomas Hospital
  • Brotman Medical Center
  • Good Samaritan Hospital
  • El Camino Hospital
  • Stanford University Medical Center
  • Florida Crdiovascular Research at JFK Medical Center
  • University of Florida
  • Mt. Sinai Medical Center
  • Baptist Hospital of Miami
  • Piedmont Hospital
  • Crawford Long Hospital
  • Emory University Hospital
  • Jewish Hospital
  • Beth Israel Deaconess Medical Center
  • Millard Fillmore Hospital
  • Millard Fillmore
  • North Shore University Hospital
  • Lenox Hill Hospital
  • Forsyth Medical Center
  • Cleveland Clinic
  • Lorain Community Hospital
  • St. John West Shore Hospital
  • Pinnacle Health Hospital
  • St. Joseph Medical Center
  • Sisters of Charity Providence Hospital
  • Methodist Germantown
  • Wellmont Holston Valley Medical Center
  • Baptist Hospital of East Tennessee
  • LDS Hospital
  • Virginia Cardiovascular Specialists/St. Mary's Hospital
  • Stadtisches Krankenhaus Neuperlach
  • CardioVasculares Centrum Frankfurt Sankt Katharinen
  • Herzzentrum Hamburg

Outcomes

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

Full Information

First Posted
November 1, 2006
Last Updated
July 20, 2007
Sponsor
Kensey Nash Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT00395785
Brief Title
Evaluation of the TriActiv ProGuard System During Carotid Artery Stenting
Official Title
Protection During Carotid Stenting in High Risk Patients With the TriActiv ProGuard System
Study Type
Interventional

2. Study Status

Record Verification Date
July 2007
Overall Recruitment Status
Terminated
Why Stopped
Sponsor elected to not pursue this indication for the study device.
Study Start Date
November 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Kensey Nash Corporation

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Stenosis
Keywords
Carotid stenosis, Intracranial Embolism, Carotid artery, Carotid stent, Embolic protection, TriActiv ProGuard System, Carotid angioplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Carotid Stent Implantation
Intervention Type
Device
Intervention Name(s)
Embolic Protection
Primary Outcome Measure Information:
Title
A composite of major adverse events including any death, any stroke and/or myocardial infarction through thirty days post-procedure.
Secondary Outcome Measure Information:
Title
Rate of subject intolerance to prolonged carotid artery occlusion;
Title
Rate of access site complications requiring treatment with blood transfusion or surgical repair.
Title
Rate of successful use of the study device success
Title
Rate of successful lesion treatment
Title
Rate of procedure success

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary S Roubin, MD
Organizational Affiliation
Lenox Hill Hospital, New York, NY
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rajesh Dave, MD
Organizational Affiliation
Pinnacle Health Hospital, Harrisburg, PA
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-0012
Country
United States
Facility Name
Thomas Hospital
City
Fairhope
State/Province
Alabama
ZIP/Postal Code
36532
Country
United States
Facility Name
Brotman Medical Center
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
Good Samaritan Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
El Camino Hospital
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Florida Crdiovascular Research at JFK Medical Center
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
University of Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Mt. Sinai Medical Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Baptist Hospital of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Piedmont Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Crawford Long Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Jewish Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Millard Fillmore Hospital
City
Buffalo
State/Province
New York
ZIP/Postal Code
14209
Country
United States
Facility Name
Millard Fillmore
City
Buffalo
State/Province
New York
ZIP/Postal Code
14209
Country
United States
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Lenox Hill Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Forsyth Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Lorain Community Hospital
City
Elyria
State/Province
Ohio
ZIP/Postal Code
44035
Country
United States
Facility Name
St. John West Shore Hospital
City
Westlake
State/Province
Ohio
ZIP/Postal Code
44145
Country
United States
Facility Name
Pinnacle Health Hospital
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17110
Country
United States
Facility Name
St. Joseph Medical Center
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Sisters of Charity Providence Hospital
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Facility Name
Methodist Germantown
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Wellmont Holston Valley Medical Center
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Baptist Hospital of East Tennessee
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
LDS Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84143
Country
United States
Facility Name
Virginia Cardiovascular Specialists/St. Mary's Hospital
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
Facility Name
Stadtisches Krankenhaus Neuperlach
City
Bayern
ZIP/Postal Code
81737
Country
Germany
Facility Name
CardioVasculares Centrum Frankfurt Sankt Katharinen
City
Frankfurt
ZIP/Postal Code
60389
Country
Germany
Facility Name
Herzzentrum Hamburg
City
Hamburg
ZIP/Postal Code
22527
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

Evaluation of the TriActiv ProGuard System During Carotid Artery Stenting

We'll reach out to this number within 24 hrs