Clinical trial NCT00395785: 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
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Carotid Stenosis
Keywords: Carotid stenosis
Intracranial Embolism
Carotid artery
Carotid stent
Embolic protection
TriActiv ProGuard System
Carotid angioplasty
Lead sponsor: Kensey Nash Corporation
Sponsor class: INDUSTRY
First posted: 2006-11-03
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: A composite of major adverse events including any death, any stroke and/or myocardial infarction through thirty days post-procedure.
Secondary outcomes:
measure: Rate of subject intolerance to prolonged carotid artery occlusion;
measure: Rate of access site complications requiring treatment with blood transfusion or surgical repair.
measure: Rate of successful use of the study device success
measure: Rate of successful lesion treatment
measure: Rate of procedure success
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham
state: Alabama
city: Fairhope
country: United States
facility: Thomas Hospital
state: Alabama
city: Beverly Hills
country: United States
facility: Brotman Medical Center
state: California
city: Los Angeles
country: United States
facility: Good Samaritan Hospital
state: California
city: Mountain View
country: United States
facility: El Camino Hospital
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Atlantis
country: United States
facility: Florida Crdiovascular Research at JFK Medical Center
state: Florida
city: Jacksonville
country: United States
facility: University of Florida
state: Florida
city: Miami Beach
country: United States
facility: Mt. Sinai Medical Center
state: Florida
city: Miami
country: United States
facility: Baptist Hospital of Miami
state: Florida
city: Atlanta
country: United States
facility: Piedmont Hospital
state: Georgia
city: Atlanta
country: United States
facility: Crawford Long Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Louisville
country: United States
facility: Jewish Hospital
state: Kentucky
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Buffalo
country: United States
facility: Millard Fillmore Hospital
state: New York
city: Buffalo
country: United States
facility: Millard Fillmore
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: Winston-Salem
country: United States
facility: Forsyth Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Elyria
country: United States
facility: Lorain Community Hospital
state: Ohio
city: Westlake
country: United States
facility: St. John West Shore Hospital
state: Ohio
city: Harrisburg
country: United States
facility: Pinnacle Health Hospital
state: Pennsylvania
city: Wyomissing
country: United States
facility: St. Joseph Medical Center
state: Pennsylvania
city: Columbia
country: United States
facility: Sisters of Charity Providence Hospital
state: South Carolina
city: Germantown
country: United States
facility: Methodist Germantown
state: Tennessee
city: Kingsport
country: United States
facility: Wellmont Holston Valley Medical Center
state: Tennessee
city: Knoxville
country: United States
facility: Baptist Hospital of East Tennessee
state: Tennessee
city: Salt Lake City
country: United States
facility: LDS Hospital
state: Utah
city: Richmond
country: United States
facility: Virginia Cardiovascular Specialists/St. Mary's Hospital
state: Virginia
city: Bayern
country: Germany
facility: Stadtisches Krankenhaus Neuperlach
city: Frankfurt
country: Germany
facility: CardioVasculares Centrum Frankfurt Sankt Katharinen
city: Hamburg
country: Germany
facility: Herzzentrum Hamburg
Study officials:
affiliation: Lenox Hill Hospital, New York, NY
name: Gary S Roubin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pinnacle Health Hospital, Harrisburg, PA
name: Rajesh Dave, MD
role: PRINCIPAL_INVESTIGATOR
References: