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)

NCT ID: NCT00106938

Last Updated: 2017-07-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1663 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-30
• Study Completion Date: 2013-03-31

Brief 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.

Detailed 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.

Conditions

Carotid Artery Disease; Carotid Stenosis; Stroke; Atherosclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

1

CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).

Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.

Group Type: ACTIVE_COMPARATOR

Carotid artery stenting with filter (interventional)

Intervention Type: DEVICE

Carotid artery stenting with filter (interventional)

2

CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).

Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.

Group Type: ACTIVE_COMPARATOR

Carotid artery endarterectomy (surgical)

Intervention Type: PROCEDURE

Carotid artery endarterectomy (surgical)

Interventions

Carotid artery stenting with filter (interventional)

Carotid artery stenting with filter (interventional)

Intervention Type: DEVICE

Carotid artery endarterectomy (surgical)

Carotid artery endarterectomy (surgical)

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. The subject must be > 18 and < 80 years of age.

2. Female subjects of child bearing potential must have a documented negative pregnancy test within 30 days prior to the study procedure.

3. Subject must be asymptomatic, defined as no stroke or Transient Ischemic Attack [(TIA);(hemispheric or ocular)] within the 180 days prior to the procedure. Subjects who have experienced these neurological symptoms prior to the 180 day pre-procedure window will be eligible for enrollment. An independent study neurologist or independent study neurosurgeon must confirm the subject's neurological status.

4. Subjects taking warfarin may be included if their dosage is reduced before the procedure to result in an International Normalized Ratio (INR) of 1.5 or less. Warfarin may be restarted after the procedure.

5. The subject must sign a written informed consent prior to the procedure, using a form that is approved by the local institutional review board (IRB).

6. The subject must agree to return for all required follow-up visits.

7. Subject has a discrete lesion located in the internal carotid artery (ICA); the contiguous common carotid artery (CCA) may be involved.

8. Carotid stenosis ≥ 70% and ≤ 99% by carotid ultrasound or ≥ 70% and ≤ 99% stenosis (visual estimate) by angiography, without significant (> 60% by ultrasound or angiography) ICA/CCA contralateral stenosis.

9. Target ICA vessel diameter must be visually estimated to be:

> 2.5 mm and < 7.0 for the Emboshield Pro or for the Emboshield NAV6, > 2.8 mm and < 6.2 for the Emboshield Gen 3 And > 4.0 mm and < 9.0 mm for the Xact stent treatment segment. An untreated contralateral ICA may be used for visual estimation when a highly stenosed lesion makes measurement of the target vessel inaccurate.

10. Based on the subject's anatomy, the Investigator should expect to successfully deliver the stent to the target lesion (absence of extreme tortuosity, etc.).

11. De novo target lesion that can be treated with a single stent.

Exclusion Criteria

1. Subject is symptomatic and has had a stroke or exhibited TIA (hemispheric or ocular) within 180 days prior to randomization, which has been confirmed by an independent study neurologist or independent study neurosurgeon.

2. Subject is participating in another drug or device trial (IND or IDE) that has not completed the primary endpoint or that may potentially confound the results of this trial. Subject may be enrolled only once in this trial and may not participate in any other clinical trial during a 1-year period post-index procedure.

3. Subject has inability to understand and cooperate with study procedures or provide informed consent.

4. Subject has had an intracranial hemorrhage or hemorrhagic stroke within 1-year prior the index procedure.

5. Subject has dementia or has a neurological illness that may confound the neurological evaluation.

6. Subject has had a known untoward reaction to anesthesia or contrast media not able to be overcome by pre-treatment with medications.

7. Subject has history of intolerance or allergic reaction to any of the study medications including aspirin, Clopidogrel bisulfate (Plavix®) or Ticlopidine (Ticlid®), heparin or Bivalirudin (Angiomax™). Subjects must be able to tolerate a combination of aspirin and Clopidogrel/Ticlopidine.

8. Subject has Hemoglobin (Hgb) less than 10 gm/dL, platelet count <100,000/mm3 or >500,000/mm3, or known heparin associated thrombocytopenia.

9. Subject has an active bleeding diathesis or coagulopathy, or will refuse blood transfusions.

10. Subject has had a GI bleed that would interfere with antiplatelet therapy.

11. Subject has known cardiac sources of emboli, including paroxysmal or sustained atrial fibrillation (treated or untreated).

12. Subject has had an myocardial infarction (MI) within the previous 30 days.

13. Subject has any condition that limits their anticipated survival to less than 3 years.

14. Subject is a high risk surgical candidate defined as the presence of any one or more of a following medical conditions:

1. Two or more proximal diseased coronary arteries of > 70% stenosis that have not or cannot be revascularized or < 30 days since revascularization.

2. Ejection fraction < 30% or New York Heart Association (NYHA) heart failure functional class 3 or higher.

3. Unstable angina, defined as angina at rest with ECG changes.

4. On a list for major organ transplant or is being evaluated for such.

5. Known history of respiratory insufficiency, forced expiratory volume (FEV1) < 30% (predicted).

6. Chronic renal insufficiency (serum creatinine >2.5 mg/dL).

7. Uncontrolled diabetes defined as fasting glucose > 400 mg/dL.

8. Concurrent requirement for any invasive procedure 30 days pre- or post-procedure.

9. Age ≥ 80 years.

15. Subject may be considered a non-surgical candidate for CEA as a result of one or more anatomic conditions or features which preclude normal surgical access or a high surgical risk because of the presence of any one or more anatomic conditions that present an increased potential for adverse events. These subjects are not eligible for enrollment.

1. Subject has had radiation treatment to the neck.

2. Subject has had a radical neck dissection.

3. Surgically inaccessible lesions (i.e., lesions extending above the level of C2).

4. Spinal immobility - inability to flex neck beyond neutral or kyphotic deformity.

5. Presence of carotid artery dissection, aneurysm, pseudoaneurysm, arteritis or fibromuscular dysplasia (FMD) in the target vessel.

6. Hemodynamically significant (>60%) stenosis of the right or left common carotid artery (LCCA/RCCA) below the clavicle.

7. Presence of tracheostomy stoma.

8. Contralateral laryngeal nerve paralysis.

9. Previous carotid endarterectomy, extracranial-intracranial or carotid subclavian bypass procedure ipsilateral to the carotid stenosis.

10. Severe hypertension (defined as blood pressure > Systolic of 180 mm Hg and/or a diastolic of 110 mm Hg) not adequately controlled by anti-hypertensive therapy at the time of study entry.

16. Severe vascular disease including tortuosity and/or occlusive disease that would preclude the safe introduction of a guiding catheter/sheath, cerebral protection device, balloon catheter, stent delivery system or stent placement. Severe tortuosity is defined as 2 or more >90 degree bend points within 3cm of the target stenosis. One of these bends will be considered to be present if the ICA branches from the CCA at a 90 degree angle. This includes aortic arch anatomy that is unacceptable for carotid stent placement.

17. Intraluminal filling defect thought to represent thrombus.

18. Excessive calcification: defined as fluoroscopic evidence of calcium that extends circumferentially around the target lesion and includes the majority of the atherosclerotic plaque.

19. Occlusion (TIMI 0 flow), or string sign of the ipsilateral common or internal carotid artery.

20. The target lesion requires treatment with a device other than percutaneous transluminal angioplasty (PTA) prior to stent placement.

21. Significant (> 60%) stenosis proximal or distal to the target lesion that might require revascularization or impede run off.

22. Presence of a previously placed intravascular stent in the ipsilateral carotid distribution.

23. Cerebral aneurysm (symptomatic or > 10 mm) or arteriovenous malformation (AVM) of the cerebral vasculature.

24. Bilateral carotid stenosis (ICA/CCA contralateral stenosis > 60% by ultrasound or angiography).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jon Matsumura, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Kenneth Rosenfield, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

St. Luke's Hospital-Phoenix

Phoenix, Arizona, United States

Mayo Clinic

Phoenix, Arizona, United States

Fogarty Clinical Research Inc./El Camino Hospital

Mountain View, California, United States

Hoag Memorial Hospital

Newport Beach, California, United States

St. Joseph Hospital

Orange, California, United States

Kaiser Foundation Hospital-San Diego

San Diego, California, United States

Washington Hospital Center

Washington D.C., District of Columbia, United States

Baptist Cardiac and Vascular Institute

Miami, Florida, United States

Piedmont Hospital

Atlanta, Georgia, United States

Northeast Georgia Medical Center

Gainesville, Georgia, United States

Hawaii Permanente Medical Group - Kaiser

Honolulu, Hawaii, United States

Northwestern University Memorial Hospital

Chicago, Illinois, United States

Rush University Medical Center

Chicago, Illinois, United States

St. John's Hospital and Memorial Medical Center/ Prairie Heart Cooperative

Springfield, Illinois, United States

Parkview Hospital

Fort Wayne, Indiana, United States

Central Baptist Hospital

Lexington, Kentucky, United States

University of Louisville

Louisville, Kentucky, United States

Cardiovascular Institute of the South

Lafayette, Louisiana, United States

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Harper University Hospital/Detroit Medical Center

Detroit, Michigan, United States

McLaren Regional Medical Center

Flint, Michigan, United States

William Beaumont Hospital

Royal Oak, Michigan, United States

St. John's Mercy Medical Center

St Louis, Missouri, United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Our Lady of Lourdes Medical Center

Camden, New Jersey, United States

Albany Medical Center

Albany, New York, United States

Millard Fillmore Hospital

Buffalo, New York, United States

NYU Medical Center

New York, New York, United States

Columbia Presbyterian Hospital

New York, New York, United States

Lenox Hill Hospital

New York, New York, United States

University of Rochester-Strong Memorial Hospital

Rochester, New York, United States

St. Francis Hospital

Roslyn, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

WakeMed Health and Hospital

Raleigh, North Carolina, United States

Forsyth Medical Center

Winston-Salem, North Carolina, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Riverside Methodist Hospital

Columbus, Ohio, United States

Oregon Health and Science University Stroke Center

Portland, Oregon, United States

Heritage Valley Health System

Beaver, Pennsylvania, United States

Harrisburg Hospital / Pinnacle Health

Harrisburg, Pennsylvania, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 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

Allegheny General Hospital

Washington, Pennsylvania, United States

St. Joseph's Medical Center/Berks Cardiologists

Wyomissing, Pennsylvania, United States

Providence Hospital-SC

Columbia, South Carolina, United States

North Central Heart Institute

Sioux Falls, South Dakota, United States

The Stern Cardiovascular Center/Methodist Germantown Hospital

Germantown, Tennessee, United States

Wellmont Holston Valley Medical Center

Kingsport, Tennessee, United States

Mercy Medical West/Turkey Creek Medical Center

Knoxville, Tennessee, United States

Westlake Medical Center/Seton Heart Institute

Austin, Texas, United States

Heart Hospital of Austin

Austin, Texas, United States

Dallas Veteran's Administration Medical Center

Dallas, Texas, United States

Presbyterian Hospital of Dallas

Dallas, Texas, United States

St. Luke's Episcopal Hospital

Houston, Texas, United States

Chesapeake General Hospital/Sentara Norfolk General Hospital

Norfolk, Virginia, United States

St. Mary's Hospital / Virginia Cardiovascular Specilists

Richmond, Virginia, United States

Deaconess Medical Center

Spokane, Washington, United States

University of Wisconsin

Madison, Wisconsin, United States

St. Luke's Medical Center - Milwaukee

Milwaukee, Wisconsin, United States

Countries

United States

References

Weinberg I, Beckman JA, Matsumura JS, Rosenfield K, Ansel GM, Chaturvedi S, Gray W, Metzger DC, Riles T, Shu Y, Wechsler L, Jaff MR. Carotid Stent Fractures Are Not Associated With Adverse Events: Results From the ACT-1 Multicenter Randomized Trial (Carotid Angioplasty and Stenting Versus Endarterectomy in Asymptomatic Subjects Who Are at Standard Risk for Carotid Endarterectomy With Significant Extracranial Carotid Stenotic Disease). Circulation. 2018 Jan 2;137(1):49-56. doi: 10.1161/CIRCULATIONAHA.117.030030. Epub 2017 Oct 5.

Reference Type: DERIVED

PMID: 28982691 (View on PubMed)

Rosenfield K, Matsumura JS, Chaturvedi S, Riles T, Ansel GM, Metzger DC, Wechsler L, Jaff MR, Gray W; ACT I Investigators. Randomized Trial of Stent versus Surgery for Asymptomatic Carotid Stenosis. N Engl J Med. 2016 Mar 17;374(11):1011-20. doi: 10.1056/NEJMoa1515706. Epub 2016 Feb 17.

Reference Type: DERIVED

PMID: 26886419 (View on PubMed)

Other Identifiers

AVD-640-0052

Identifier Type: -

Identifier Source: org_study_id