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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) (ACT I)

2017年6月20日 更新者：Abbott Medical Devices
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.

調査の概要

状態

終了しました

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (実際)

1663

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アメリカ
    • Arizona
      • Phoenix、Arizona、アメリカ、85054
        • Mayo Clinic
      • Phoenix、Arizona、アメリカ、85006
        • St. Luke's Hospital-Phoenix
    • California
      • Mountain View、California、アメリカ、94040
        • Fogarty Clinical Research Inc./El Camino Hospital
      • Newport Beach、California、アメリカ、92663
        • Hoag Memorial Hospital
      • Orange、California、アメリカ、92868
        • St. Joseph Hospital
      • San Diego、California、アメリカ、92120
        • Kaiser Foundation Hospital-San Diego
    • District of Columbia
      • Washington, D.C.、District of Columbia、アメリカ、20010
        • Washington Hospital Center
    • Florida
      • Miami、Florida、アメリカ、33176
        • Baptist Cardiac and Vascular Institute
    • Georgia
      • Atlanta、Georgia、アメリカ、30309
        • Piedmont Hospital
      • Gainesville、Georgia、アメリカ、30501
        • Northeast Georgia Medical Center
    • Hawaii
      • Honolulu、Hawaii、アメリカ、96817
        • Hawaii Permanente Medical Group - Kaiser
    • Illinois
      • Chicago、Illinois、アメリカ、60612
        • Rush University Medical Center
      • Chicago、Illinois、アメリカ、60611
        • Northwestern University Memorial Hospital
      • Springfield、Illinois、アメリカ、62701
        • St. John's Hospital and Memorial Medical Center/ Prairie Heart Cooperative
    • Indiana
      • Fort Wayne、Indiana、アメリカ、46805
        • Parkview Hospital
    • Kentucky
      • Lexington、Kentucky、アメリカ、40503
        • Central Baptist Hospital
      • Louisville、Kentucky、アメリカ、40292
        • University of Louisville
    • Louisiana
      • Lafayette、Louisiana、アメリカ、70506
        • Cardiovascular Institute of the South
      • New Orleans、Louisiana、アメリカ、70121
        • Ochsner Clinic Foundation
    • Maryland
      • Baltimore、Maryland、アメリカ、21224
        • Johns Hopkins Bayview Medical Center
    • Massachusetts
      • Boston、Massachusetts、アメリカ、02114
        • Massachusetts General Hospital
    • Michigan
      • Detroit、Michigan、アメリカ、48201
        • Harper University Hospital/Detroit Medical Center
      • Flint、Michigan、アメリカ、48507
        • McLaren Regional Medical Center
      • Royal Oak、Michigan、アメリカ、48073
        • William Beaumont Hospital
    • Missouri
      • Saint Louis、Missouri、アメリカ、63141
        • St. John's Mercy Medical Center
    • New Hampshire
      • Lebanon、New Hampshire、アメリカ、03756
        • Dartmouth Hitchcock Medical Center
    • New Jersey
      • Camden、New Jersey、アメリカ、08103
        • Our Lady of Lourdes Medical Center
    • New York
      • Albany、New York、アメリカ、12208
        • Albany Medical Center
      • Buffalo、New York、アメリカ、14209
        • Millard Fillmore Hospital
      • New York、New York、アメリカ、10021
        • Lenox Hill Hospital
      • New York、New York、アメリカ、10016
        • NYU Medical Center
      • New York、New York、アメリカ、10021
        • Columbia Presbyterian Hospital
      • Rochester、New York、アメリカ、14623
        • University of Rochester-Strong Memorial Hospital
      • Roslyn、New York、アメリカ、11576
        • St. Francis Hospital
    • North Carolina
      • Durham、North Carolina、アメリカ、27609
        • Duke University Medical Center
      • Raleigh、North Carolina、アメリカ、27610
        • Wakemed Health and Hospital
      • Winston-Salem、North Carolina、アメリカ、27103
        • Forsyth Medical Center
    • Ohio
      • Cleveland、Ohio、アメリカ、44195
        • Cleveland Clinic Foundation
      • Columbus、Ohio、アメリカ、43214
        • Riverside Methodist Hospital
    • Oregon
      • Portland、Oregon、アメリカ、97239
        • Oregon Health and Science University Stroke Center
    • Pennsylvania
      • Beaver、Pennsylvania、アメリカ、15009
        • Heritage Valley Health System
      • Harrisburg、Pennsylvania、アメリカ、17110
        • Harrisburg Hospital / Pinnacle Health
      • Philadelphia、Pennsylvania、アメリカ、19104
        • Hospital of the University of Pennsylvania
      • Pittsburgh、Pennsylvania、アメリカ、15213
        • University of Pittsburgh Medical Center (UPMC)
      • Pittsburgh、Pennsylvania、アメリカ、15232
        • University of Pittsburgh Physicians Division of Vascular Surgery/Shadyside Medical
      • Washington、Pennsylvania、アメリカ、15301
        • Allegheny General Hospital
      • Wyomissing、Pennsylvania、アメリカ、19610
        • St. Joseph's Medical Center/Berks Cardiologists
    • South Carolina
      • Columbia、South Carolina、アメリカ、29204
        • Providence Hospital-SC
    • South Dakota
      • Sioux Falls、South Dakota、アメリカ、57108
        • North Central Heart Institute
    • Tennessee
      • Germantown、Tennessee、アメリカ、38138
        • The Stern Cardiovascular Center/Methodist Germantown Hospital
      • Kingsport、Tennessee、アメリカ、37660
        • Wellmont Holston Valley Medical Center
      • Knoxville、Tennessee、アメリカ、37934
        • Mercy Medical West/Turkey Creek Medical Center
    • Texas
      • Austin、Texas、アメリカ、78756
        • Heart Hospital of Austin
      • Austin、Texas、アメリカ、78705
        • Westlake Medical Center/Seton Heart Institute
      • Dallas、Texas、アメリカ、75231
        • Presbyterian Hospital of Dallas
      • Dallas、Texas、アメリカ、75216
        • Dallas Veteran's Administration Medical Center
      • Houston、Texas、アメリカ、77030
        • St. Luke's Episcopal Hospital
    • Virginia
      • Norfolk、Virginia、アメリカ、23507
        • Chesapeake General Hospital/Sentara Norfolk General Hospital
      • Richmond、Virginia、アメリカ、23226
        • St. Mary's Hospital / Virginia Cardiovascular Specilists
    • Washington
      • Spokane、Washington、アメリカ、99204
        • Deaconess Medical Center
    • Wisconsin
      • Madison、Wisconsin、アメリカ、53792
        • University of Wisconsin
      • Milwaukee、Wisconsin、アメリカ、53215
        • St. Luke's Medical Center - Milwaukee

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年～79年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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:

Each potential subject must be screened to ensure that they do not meet any of the following exclusion criteria. This screening is to be based on known medical history and data available at the time of eligibility determination and enrollment.

  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).

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：他の
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ：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.
デバイス：Carotid artery stenting with filter (interventional)
Carotid artery stenting with filter (interventional)
アクティブコンパレータ：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.
手順：Carotid artery endarterectomy (surgical)
Carotid artery endarterectomy (surgical)

この研究は何を測定していますか？

主要な結果の測定

結果測定
時間枠
Composite of Death, Stroke (Ipsilateral or Contralateral; Major or Minor) and Myocardial Infarction (DSMI) Through 30 Days Post-procedure, Plus Ipsilateral Stroke 31 to 365 Days.
時間枠：0 to 365 days
0 to 365 days

二次結果の測定

結果測定
メジャーの説明
時間枠
Acute Device Success: Xact Carotid Stent
時間枠：On day 0 after index procedure
Defined as attainment of final residual diameter stenosis of < 50% by Qualitative Comparative Analysis (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.
On day 0 after index procedure
Acute Device Success: Embolic Protection Device System
時間枠：On day 0 after index procedure
Defined as successful deployment and retrieval of the filter in the absence of angiographic distal embolization.
On day 0 after index procedure
Procedural Success
時間枠：0 to 30 days post procedure
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.
0 to 30 days post procedure
Composite Morbidity Measure
時間枠：0 to 30 Days Post-procedure
A pre-specified composite Morbidity Measure (CMM) of cranial and peripheral nerve injury, vascular injury, non-cerebral bleeding, wound complications related to the neck incision or femoral puncture site, and other complications (anesthetic) at 30 days post-procedure.
0 to 30 Days Post-procedure
Freedom From Clinically Indicated Target Lesion Revascularization(CI-TLR)
時間枠：0 to 180 days
Freedom from CI-TLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients.
0 to 180 days
Freedom From Clinically Indicated Target Lesion Revascularization
時間枠：0 to 365 days
Freedom from CITLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients.
0 to 365 days
Freedom From Clinically Indicated Target Lesion Revascularization
時間枠：0 to 730 days
Freedom from CITLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients.
0 to 730 days
Freedom From Clinically Indicated Target Lesion Revascularization
時間枠：0 to 1095 days
Freedom from CITLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients.
0 to 1095 days
Freedom From Clinically Indicated Target Lesion Revascularization
時間枠：0 to 1460 days
Freedom from CITLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients.
0 to 1460 days
Freedom From Clinically Indicated Target Lesion Revascularization
時間枠：0 to 1825 days
Freedom from CITLR was defined as freedom from reintervention for ≥ 50% restenosis in recently symptomatic patients and ≥ 80% restenosis in asymptomatic patients.
0 to 1825 days
Freedom From Ipsilateral Stroke
時間枠：31 to 365 days
Ipsilateral stroke was defined as stroke in the vascular distribution of the study carotid artery. If a subject experienced a bilateral stroke it was counted as an ipsilateral stroke for analysis purposes.
31 to 365 days
Freedom From Ipsilateral Stroke
時間枠：31 to 730 days
Ipsilateral stroke was defined as stroke in the vascular distribution of the study carotid artery. If a subject experienced a bilateral stroke it was counted as an ipsilateral stroke for analysis purposes.
31 to 730 days
Freedom From Ipsilateral Stroke
時間枠：31 to 1095 days
Ipsilateral stroke was defined as stroke in the vascular distribution of the study carotid artery. If a subject experienced a bilateral stroke it was counted as an ipsilateral stroke for analysis purposes.
31 to 1095 days
Freedom From Ipsilateral Stroke
時間枠：31 to 1460 days
Ipsilateral stroke was defined as stroke in the vascular distribution of the study carotid artery. If a subject experienced a bilateral stroke it was counted as an ipsilateral stroke for analysis purposes.
31 to 1460 days
Freedom From Ipsilateral Stroke
時間枠：31 to 1825 days
Ipsilateral stroke was defined as stroke in the vascular distribution of the study carotid artery. If a subject experienced a bilateral stroke it was counted as an ipsilateral stroke for analysis purposes.
31 to 1825 days
Freedom From Mortality
時間枠：0 to 365 days
0 to 365 days
Freedom From Mortality
時間枠：0 to 730 days
0 to 730 days
Freedom From Mortality
時間枠：0 to 1095 days
0 to 1095 days
Freedom From Mortality
時間枠：0 to 1460 days
0 to 1460 days
Freedom From Mortality
時間枠：0 to 1825 days
0 to 1825 days
Freedom From All Stroke
時間枠：0 to 365 days
0 to 365 days
Freedom From All Stroke
時間枠：0 to 730 days
0 to 730 days
Freedom From All Stroke
時間枠：0 to 1095 days
0 to 1095 days
Freedom From All Stroke
時間枠：0 to 1460 days
0 to 1460 days
Freedom From All Stroke
時間枠：0 to 1825 days
0 to 1825 days
Death (Non-Hierarchical)
時間枠：≤ 30 Days Post Index Procedure
≤ 30 Days Post Index Procedure
All Stroke (Non-Hierarchical)
時間枠：≤ 30 Days Post Index Procedure
≤ 30 Days Post Index Procedure
Myocardial Infarction (MI) (Non-Hierarchical)
時間枠：≤ 30 Days Post Index Procedure
≤ 30 Days Post Index Procedure
Death, Stroke or Myocardial Infarction (MI) (Hierarchical)
時間枠：≤ 30 Days Post Index Procedure
≤ 30 Days Post Index Procedure
Death or Stroke (Hierarchical)
時間枠：≤ 30 Days Post Index Procedure
≤ 30 Days Post Index Procedure
Death or Major Stroke (Hierarchical)
時間枠：≤ 30 Days Post Index Procedure
≤ 30 Days Post Index Procedure
Freedom From Death, Stroke and MI Within 30 Days and Ipsilateral Stroke From 31 Days to 5 Years
時間枠：0 to 5 years
0 to 5 years

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Abbott Medical Devices

捜査官

  • 主任研究者：Jon Matsumura, MD、University of Wisconsin, Madison

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2005年4月1日

一次修了 (実際)

2013年3月1日

研究の完了 (実際)

2013年3月1日

試験登録日

最初に提出

2005年4月1日

QC基準を満たした最初の提出物

2005年4月1日

最初の投稿 (見積もり)

2005年4月4日

学習記録の更新

投稿された最後の更新 (実際)

2017年7月19日

QC基準を満たした最後の更新が送信されました

2017年6月20日

最終確認日

2017年6月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • AVD-640-0052

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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