Evaluation of the TriActiv ProGuard System During Carotid Artery Stenting

Carotid Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00395785
• Other study ID #: PROGUARD
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: November 1, 2006
• Last updated: July 20, 2007
• Start date: November 2006
• Est. completion date: June 2007

Study information

• Verified date: July 2007
• Source: Kensey Nash Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 400
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Carotid Stenosis

Intervention

Device:
• Carotid Stent Implantation

• Embolic Protection

Locations

Country	Name	City	State
Germany	Stadtisches Krankenhaus Neuperlach	Bayern
Germany	CardioVasculares Centrum Frankfurt Sankt Katharinen	Frankfurt
Germany	Herzzentrum Hamburg	Hamburg
United States	Crawford Long Hospital	Atlanta	Georgia
United States	Emory University Hospital	Atlanta	Georgia
United States	Piedmont Hospital	Atlanta	Georgia
United States	Florida Crdiovascular Research at JFK Medical Center	Atlantis	Florida
United States	Brotman Medical Center	Beverly Hills	California
United States	University of Alabama Birmingham	Birmingham	Alabama
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Millard Fillmore	Buffalo	New York
United States	Millard Fillmore Hospital	Buffalo	New York
United States	Cleveland Clinic	Cleveland	Ohio
United States	Sisters of Charity Providence Hospital	Columbia	South Carolina
United States	Lorain Community Hospital	Elyria	Ohio
United States	Thomas Hospital	Fairhope	Alabama
United States	Methodist Germantown	Germantown	Tennessee
United States	Pinnacle Health Hospital	Harrisburg	Pennsylvania
United States	University of Florida	Jacksonville	Florida
United States	Wellmont Holston Valley Medical Center	Kingsport	Tennessee
United States	Baptist Hospital of East Tennessee	Knoxville	Tennessee
United States	Good Samaritan Hospital	Los Angeles	California
United States	Jewish Hospital	Louisville	Kentucky
United States	North Shore University Hospital	Manhasset	New York
United States	Baptist Hospital of Miami	Miami	Florida
United States	Mt. Sinai Medical Center	Miami Beach	Florida
United States	El Camino Hospital	Mountain View	California
United States	Lenox Hill Hospital	New York	New York
United States	Virginia Cardiovascular Specialists/St. Mary's Hospital	Richmond	Virginia
United States	LDS Hospital	Salt Lake City	Utah
United States	Stanford University Medical Center	Stanford	California
United States	St. John West Shore Hospital	Westlake	Ohio
United States	Forsyth Medical Center	Winston-Salem	North Carolina
United States	St. Joseph Medical Center	Wyomissing	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Kensey Nash Corporation

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A composite of major adverse events including any death, any stroke and/or myocardial infarction through thirty days post-procedure.
Secondary	Rate of subject intolerance to prolonged carotid artery occlusion;
Secondary	Rate of access site complications requiring treatment with blood transfusion or surgical repair.
Secondary	Rate of successful use of the study device success
Secondary	Rate of successful lesion treatment
Secondary	Rate of procedure success