이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

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)

2017년 6월 20일 업데이트: 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.

연구 개요

상태

종료됨

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

1663

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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).

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 다른
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: 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.
장치: Carotid artery stenting with filter (interventional)
Carotid artery stenting with filter (interventional)
활성 비교기: 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.
절차: Carotid artery endarterectomy (surgical)
Carotid artery endarterectomy (surgical)

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
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.
기간: 0 to 365 days
0 to 365 days

2차 결과 측정

결과 측정
측정값 설명
기간
Acute Device Success: Xact Carotid Stent
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 0 to 365 days
0 to 365 days
Freedom From Mortality
기간: 0 to 730 days
0 to 730 days
Freedom From Mortality
기간: 0 to 1095 days
0 to 1095 days
Freedom From Mortality
기간: 0 to 1460 days
0 to 1460 days
Freedom From Mortality
기간: 0 to 1825 days
0 to 1825 days
Freedom From All Stroke
기간: 0 to 365 days
0 to 365 days
Freedom From All Stroke
기간: 0 to 730 days
0 to 730 days
Freedom From All Stroke
기간: 0 to 1095 days
0 to 1095 days
Freedom From All Stroke
기간: 0 to 1460 days
0 to 1460 days
Freedom From All Stroke
기간: 0 to 1825 days
0 to 1825 days
Death (Non-Hierarchical)
기간: ≤ 30 Days Post Index Procedure
≤ 30 Days Post Index Procedure
All Stroke (Non-Hierarchical)
기간: ≤ 30 Days Post Index Procedure
≤ 30 Days Post Index Procedure
Myocardial Infarction (MI) (Non-Hierarchical)
기간: ≤ 30 Days Post Index Procedure
≤ 30 Days Post Index Procedure
Death, Stroke or Myocardial Infarction (MI) (Hierarchical)
기간: ≤ 30 Days Post Index Procedure
≤ 30 Days Post Index Procedure
Death or Stroke (Hierarchical)
기간: ≤ 30 Days Post Index Procedure
≤ 30 Days Post Index Procedure
Death or Major Stroke (Hierarchical)
기간: ≤ 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
기간: 0 to 5 years
0 to 5 years

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Abbott Medical Devices

수사관

  • 수석 연구원: Jon Matsumura, MD, University of Wisconsin, Madison

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2005년 4월 1일

기본 완료 (실제)

2013년 3월 1일

연구 완료 (실제)

2013년 3월 1일

연구 등록 날짜

최초 제출

2005년 4월 1일

QC 기준을 충족하는 최초 제출

2005년 4월 1일

처음 게시됨 (추정)

2005년 4월 4일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2017년 7월 19일

QC 기준을 충족하는 마지막 업데이트 제출

2017년 6월 20일

마지막으로 확인됨

2017년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • AVD-640-0052

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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스폰서 / 협력자

위치

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