Carotid Angioplasty and Stenting Versus Endarterectomy in Asymptomatic Subjects Who Are at Standard Risk for Carotid Endarterectomy With Significant Extracranial Carotid Stenotic Disease (ACT I)

Stroke Clinical Trial

— ACT I  

Official title:

Carotid Angioplasty and Stenting Versus Endarterectomy in Asymptomatic Subjects Who Are at Standard Risk for Carotid Endarterectomy With Significant Extracranial Carotid Stenotic Disease (ACT I)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00106938
• Other study ID #: AVD-640-0052
• Status: Terminated
• Phase: Phase 3
• First received: April 1, 2005
• Last updated: October 13, 2014
• Start date: April 2005
• Est. completion date: March 2013

Study information

• Verified date: October 2014
• Source: Abbott Vascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The study is being conducted to demonstrate the non-inferiority of carotid artery stenting (CAS) using the Emboshield® Embolic Protection System with the Xact® Carotid Stent System to carotid endarterectomy (CEA) for the treatment of asymptomatic extracranial carotid atherosclerotic disease.

Description:

Randomization for ACT 1 employs a 3:1 ratio of CAS versus CEA. A lead-in phase of up to 400 carotid stent subjects will provide investigators experience with the study devices prior to pivotal enrollment.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1663
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

Inclusion Criteria:

• Severe carotid artery disease

• Patients who have not had symptoms related to their carotid artery disease in the last 180 days

• Patients who are able to undergo either an interventional stenting or surgical procedure

Exclusion Criteria:

• Patients who have had symptoms in the last 180 days

• Patients who are high risk for surgery

• Patients who have certain conditions that might confound the results of the study

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Atherosclerosis
• Carotid Artery Disease
• Carotid Artery Diseases
• Carotid Stenosis
• Stroke

Intervention

Device:
• Carotid artery stenting with filter (interventional)
Carotid artery stenting with filter (interventional)

Procedure:
• Carotid artery endarterectomy (surgical)
Carotid artery endarterectomy (surgical)

Locations

Country	Name	City	State
United States	Albany Medical Center	Albany	New York
United States	Piedmont Hospital	Atlanta	Georgia
United States	Heart Hospital of Austin	Austin	Texas
United States	Westlake Medical Center/Seton Heart Institute	Austin	Texas
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland
United States	Heritage Valley Health System	Beaver	Pennsylvania
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Millard Fillmore Hospital	Buffalo	New York
United States	Our Lady of Lourdes Medical Center	Camden	New Jersey
United States	Northwestern University Memorial Hospital	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Providence Hospital-SC	Columbia	South Carolina
United States	Riverside Methodist Hospital	Columbus	Ohio
United States	Dallas Veteran's Administration Medical Center	Dallas	Texas
United States	Presbyterian Hospital of Dallas	Dallas	Texas
United States	Harper University Hospital/Detroit Medical Center	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	McLaren Regional Medical Center	Flint	Michigan
United States	Parkview Hospital	Fort Wayne	Indiana
United States	Northeast Georgia Medical Center	Gainesville	Georgia
United States	The Stern Cardiovascular Center/Methodist Germantown Hospital	Germantown	Tennessee
United States	Harrisburg Hospital / Pinnacle Health	Harrisburg	Pennsylvania
United States	Hawaii Permanente Medical Group - Kaiser	Honolulu	Hawaii
United States	St. Luke's Episcopal Hospital	Houston	Texas
United States	Wellmont Holston Valley Medical Center	Kingsport	Tennessee
United States	Mercy Medical West/Turkey Creek Medical Center	Knoxville	Tennessee
United States	Cardiovascular Institute of the South	Lafayette	Louisiana
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	Central Baptist Hospital	Lexington	Kentucky
United States	University of Louisville	Louisville	Kentucky
United States	University of Wisconsin	Madison	Wisconsin
United States	Baptist Cardiac and Vascular Institute	Miami	Florida
United States	St. Luke's Medical Center - Milwaukee	Milwaukee	Wisconsin
United States	Fogarty Clinical Research Inc./El Camino Hospital	Mountain View	California
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Columbia Presbyterian Hospital	New York	New York
United States	Lenox Hill Hospital	New York	New York
United States	NYU Medical Center	New York	New York
United States	Hoag Memorial Hospital	Newport Beach	California
United States	Chesapeake General Hospital/Sentara Norfolk General Hospital	Norfolk	Virginia
United States	St. Joseph Hospital	Orange	California
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Mayo Clinic	Phoenix	Arizona
United States	St. Luke's Hospital-Phoenix	Phoenix	Arizona
United States	University of Pittsburgh Medical Center (UPMC)	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Physicians Division of Vascular Surgery/Shadyside Medical	Pittsburgh	Pennsylvania
United States	Oregon Health and Science University Stroke Center	Portland	Oregon
United States	WakeMed Health and Hospital	Raleigh	North Carolina
United States	St. Mary's Hospital / Virginia Cardiovascular Specilists	Richmond	Virginia
United States	University of Rochester-Strong Memorial Hospital	Rochester	New York
United States	St. Francis Hospital	Roslyn	New York
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Kaiser Foundation Hospital-San Diego	San Diego	California
United States	North Central Heart Institute	Sioux Falls	South Dakota
United States	Deaconess Medical Center	Spokane	Washington
United States	St. John's Hospital and Memorial Medical Center/ Prairie Heart Cooperative	Springfield	Illinois
United States	St. John's Mercy Medical Center	St. Louis	Missouri
United States	Allegheny General Hospital	Washington	Pennsylvania
United States	Washington Hospital Center	Washington	District of Columbia
United States	Forsyth Medical Center	Winston-Salem	North Carolina
United States	St. Joseph's Medical Center/Berks Cardiologists	Wyomissing	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Vascular

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of Any Death, Stroke, and Myocardial Infarction (MI) Within 30 Days Post-index Procedure	Major adverse events = Composite of any stroke, myocardial infarction and death during the 30-day post-procedural period.	0 to 30 days	Yes
Primary	Composite of Any Death, Stroke, and MI Within 30 Days and Ipsilateral Stroke 31 Days to 365 Days	Major adverse events = Composite of any stroke, myocardial infarction and death during the 30-day post-procedural period and ipsilateral strokes between 31 and 365 days post-procedure.	0 to 365 days	Yes
Secondary	Acute Device Success: Xact Stent	Acute device success is defined as attainment of final residual diameter stenosis of < 50% by QCA (if QCA is not available, the visual estimate of diameter stenosis will be used) covering an area no longer than the original lesion with the study stent. (Routine post-dilatation of the stent may be included in this definition). Placement of an additional stent to treat a dissection or procedural complication as a bailout will not be considered a device success.	0 to 30 days post procedure	Yes
Secondary	Acute Device Success: Embolic Protection Device System	Acute device success is defined as attainment of final residual diameter stenosis of < 50% by QCA (if QCA is not available, the visual estimate of diameter stenosis will be used) covering an area no longer than the original lesion with the study stent. (Routine post-dilatation of the stent may be included in this definition). Placement of an additional stent to treat a dissection or procedural complication as a bailout will not be considered a device success.	0 to 30 days post procedure	Yes
Secondary	Procedural Success	Procedural success is defined as the attainment of target lesion final residual diameter stenosis of < 50% by QCA (if QCA is not available, the visual estimate of diameter stenosis will be used) using any procedural method and freedom of Major Adverse Event at 30 days.; Angiographic data was not required for CEA arm, therefore the procedure success assessment was not available for CEA arm.	0 to 30 days post procedure	No
Secondary	Composite Morbidity Measure	Composite Morbidity Measure = Cranial and peripheral nerve injury (cranial/cervical, femoral, peroneal, or other), vascular injury (including CAS access artery injury), non-cerebral bleeding, hematoma, or pseudoaneurysm, CEA wound or access artery wound, general anesthesia/allergic reaction/airway complications.	0 to 30 Days Post-procedure	Yes
Secondary	Freedom From Clinically Indicated Target Lesion Revascularization		0 to 180 days	Yes
Secondary	Freedom From Clinically Indicated Target Lesion Revascularization		0 to 365 days	Yes
Secondary	Freedom From Clinically Indicated Target Lesion Revascularization		0 to 730 days	Yes
Secondary	Freedom From Clinically Indicated Target Lesion Revascularization		0 to 1095 days	Yes
Secondary	Freedom From Clinically Indicated Target Lesion Revascularization		0 to 1460 days	Yes
Secondary	Freedom From Clinically Indicated Target Lesion Revascularization		0 to 1825 days	Yes
Secondary	Freedom From Ipsilateral Stroke		31 to 365 days	Yes
Secondary	Freedom From Ipsilateral Stroke		31 to 730 days	Yes
Secondary	Freedom From Ipsilateral Stroke		31 to 1095 days	Yes
Secondary	Freedom From Ipsilateral Stroke		31 to 1460 days	Yes
Secondary	Freedom From Ipsilateral Stroke		31 to 1825 days	Yes
Secondary	Freedom From Mortality		0 to 365 days	Yes
Secondary	Freedom From Mortality		0 to 730 days	Yes
Secondary	Freedom From Mortality		0 to 1095 days	Yes
Secondary	Freedom From Mortality		0 to 1460 days	Yes
Secondary	Freedom From Mortality		0 to 1825 days	Yes