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Protected Carotid Artery Stenting in Subjects at High Risk for Carotid Endarterectomy (CEA) (PROTECT) (PROTECT)

Primary Purpose

Carotid Artery Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Xact Stent with either Emboshield Pro (Gen 5) or Emboshield (Gen 3)
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carotid Artery Disease focused on measuring Carotid, Artery, Disease, Stent, PROTECT, XACT, EMBOSHIELD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Subject must be ≥ 18 years of age.

Subject has the ability to cooperate with study procedures and agrees to return for all required follow-up visits, tests and exams.

Female subjects of childbearing potential must have a documented negative pregnancy test within 30 days prior to the index procedure.

Subjects taking warfarin may be included if their dosage is reduced before the index procedure to result in an INR of 1.5 or less. Warfarin may be restarted to therapeutic dose after the index procedure.

The subject must sign a written informed consent prior to the initiation of any study procedures, using a form that is approved by the Institutional Review Board (IRB) or Medical Ethics Committee (EC).

The life expectancy of the subject is at least two years.

The subject has a lesion located in the internal carotid artery (ICA); the carotid bifurcation may be involved.

The target lesion is intended to be treated with a single stent.

Target ICA vessel diameter must be visually estimated to be:

  • ≥2.5 mm and ≤7.0 for the Emboshield Pro (Gen 5)
  • ≥ 2.8 mm and ≤6.2 for the Emboshield (Gen 3)

And

  • ≥4.0 mm and ≤9.0 mm for the Xact Stent treatment area.

The subject has a carotid artery stenosis determined by ultrasound or angiography (visual estimate) to be:

  • ≥50% for symptomatic subjects

Or

  • ≥80% for asymptomatic subjects

High-risk inclusion criteria for either anatomical or co-morbid risk factors are present. The subject must fulfill at least one of the criteria, Category I or II risk factors, listed below to meet the inclusion criteria.

Category I Anatomic Risk Factors

  • Previous radiation treatment to the neck or radical neck dissection
  • Target lesion is at or above the second vertebral body C2 (level of jaw)
  • Inability to extend the head due to cervical arthritis or other cervical disorders
  • Tracheostomy or tracheal stoma
  • Laryngectomy
  • Contralateral laryngeal nerve palsy
  • Severe tandem lesions

Category II Co-morbid Risk Factors

  • Previous CEA with significant restenosis (as defined for symptomatic or asymptomatic subjects)
  • Total occlusion of the contralateral carotid artery
  • Left ventricular ejection fraction < 35%
  • Congestive Heart failure New York Heart Association (NYHA) Functional Class III or higher
  • Dialysis dependent renal failure
  • Canadian Cardiovascular Society Angina Classification III or higher or unstable angina
  • Requires coronary artery bypass surgery, cardiac valve surgery, peripheral vascular surgery, or abdominal aortic aneurysm repair within 60 days

    •≥80 years of age

  • Myocardial infarction within previous 6 weeks
  • Abnormal stress test. Treadmill, thallium or dobutamine echo are acceptable. The stress tests should be sufficiently abnormal to place the subject at increased risk for CEA. This includes subjects with two or more proximal diseased coronary arteries of >70% stenosis that have not or cannot be revascularized or <30 days since revascularization.
  • Severe pulmonary disease, including at least one of the following: requires chronic O2 therapy; resting PO2 ≤60 mm Hg, Hematocrit ≥50%, FEV₁ or DLCO ≤50% of normal.

Exclusion Criteria

  • The subject is participating in another investigational trial that would interfere with the conduct or result of this study.
  • The subject has dementia or a neurological illness that may confound the neurological evaluation.
  • Total occlusion of the target vessel.
  • There is an existing, previously placed stent in the target artery.
  • The subject has a known life-threatening allergy to the contrast media that cannot be treated.
  • 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 or aspirin and Ticlopidine.
  • The subject has a GI bleed that would interfere with antiplatelet therapy.
  • The subject has known cardiac sources of emboli, including but not limited to current or past history of paroxysmal or sustained atrial fibrillation (treated or untreated), valve replacement, etc.
  • Subject has Hemoglobin (Hgb) less than 8 gm/dL (unless on dialysis), platelet count <50,000/mm3, or known heparin associated thrombocytopenia.
  • The subject has a history of bleeding diathesis or coagulopathy including thrombocytopenia or an inability to receive heparin or Bivalirudin (Angiomax™) in amounts sufficient to maintain an ACT of >250, or will refuse blood transfusion.
  • The subject has atherosclerotic disease involving adjoining vessels that precludes safe placement of the guiding catheter or sheath.
  • The subject has other abnormal angiographic findings that indicate the subject is at risk for a stroke due to a problem other than that of the target lesion, such as: ipsilateral arterial stenosis greater in severity than the target lesion, cerebral aneurysm, or arteriovenous malformation of the cerebral vasculature.
  • There is evidence of a carotid artery dissection prior to the initiation of the index procedure.
  • There is an angiographically visible thrombus.
  • There is any condition that precludes proper angiographic assessment, placement of the cerebral protective system or makes percutaneous arterial access unsafe, e.g. morbid obesity, sustained systolic blood pressure >180 mm Hg, tortuosity, occlusive disease, vessel anatomy, or aortic arch anatomy.
  • Occlusion (TIMI 0 flow), or string sign of the ipsilateral common or internal carotid artery.
  • There is evidence of bilateral carotid stenosis that would require intervention within 30 days of the index procedure.
  • There is evidence of a stroke within the previous 30 days of the index procedure.
  • There is a planned treatment of a non-target lesion within 30 days post-index procedure.
  • There is a history of intracranial hemorrhage within the previous 3 months, including hemorrhagic transformation of an ischemic stroke.
  • There is a history of an ipsilateral stroke with fluctuating neurologic symptoms within one year of the index procedure.

Sites / Locations

  • Washington Hospital
  • El Camino Hospital
  • Hoag Memorial Hospital Presbyterian
  • Stanford University Medical Center
  • University of Connecticut Health Center
  • Memorial Hospital Jacksonville
  • Lakeland Regional Medical Center
  • Munroe Regional Medical Center
  • Hawaii Permanente Medical Group-Kaiser Foundation Hospital
  • Northwestern University Memorial Hospital
  • St. John's Hospital / Memorial Medical Center
  • Parkview Hospital
  • St. Vincent Hospital and Health Care Center
  • Terrebonne General Medical Center
  • Washington Adventist Hospital
  • Massachusetts General Hospital
  • St. Joseph Mercy Hospital
  • McLaren Regional Medical Center
  • Genesys Regional Medical Center
  • William Beaumont Hospital
  • Our Lady of Lourdes Medical Center
  • St. Michael's Medical Center
  • Millard Fillmore Hospital-Kaleida Health Systems
  • Lenox Hill Hospital
  • WakeMed Hospital
  • Oregon Health & Science University
  • Lehigh Valley Hospital
  • Pinnacle Health Hospital
  • St. Joseph's Medical center
  • Greenville Memorial Medical Center
  • Holston Valley Medical Center
  • Mercy Medical Center West / Baptist Hospital of East Tennessee
  • Austin Heart P.A.
  • Presbyterian Heart Institute
  • St. Luke's Episcopal Hospital
  • Chesapeake General Hospital
  • Bon Secours St. Mary's Hospital
  • St. Luke's Medical Center

Outcomes

Primary Outcome Measures

Kaplan-Meier Estimate of Freedom From the Composite of Any Death, Stroke and MI During the 30 Day Post Procedural Period (DSMI), Plus Fatal and Non-fatal Ipsilateral Stroke From 31-365 Days and Annually Thereafter for a Total of 3 Years.
Freedom from DSMI to 30 days or ipsilateral stroke from 31 days to 3 years. KM event free (%) curve.

Secondary Outcome Measures

Acute Device Success
Defined by the attainment of <50% residual stenosis covering an area no longer than the original lesion treated with the stent.
Procedural Success
Defined as the attainment of less than 50% residual stenosis (per angiographic core lab) of the target lesion and the absence of DSMI at 30 days post-index procedure.
Composite of Any Transient Ischemic Attack (TIA) and Amaurosis Fugax
Includes only each subject's first occurrence of each event.
Kapan-Meier Estimate of Freedom From Clinically Driven Target Lesion Revascularization Through Three Years.

Full Information

First Posted
November 20, 2006
Last Updated
May 17, 2012
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT00402740
Brief Title
Protected Carotid Artery Stenting in Subjects at High Risk for Carotid Endarterectomy (CEA) (PROTECT)
Acronym
PROTECT
Official Title
Protected Carotid Artery Stenting in Subjects at High Risk for Carotid Endarterectomy (CEA)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the long-term safety and efficacy of the Xact™ Rapid Exchange Carotid Stent System used in conjunction with the Emboshield® Pro Rapid Exchange Embolic Protection System (Generation 5) and the Emboshield® BareWire™ Rapid Exchange Embolic Protection System (Generation 3), in the treatment of atherosclerotic carotid artery disease in high-surgical risk subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Artery Disease
Keywords
Carotid, Artery, Disease, Stent, PROTECT, XACT, EMBOSHIELD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
322 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Xact Stent with either Emboshield Pro (Gen 5) or Emboshield (Gen 3)
Other Intervention Name(s)
Xact stent, Emboshield Pro (Gen 5), Emboshield (Gen 3)
Intervention Description
All subjects will receive the Xact™ Rapid Exchange Carotid Stent System. The first 220 consecutively enrolled subjects will be treated with the investigational filter system, the Emboshield® Pro Rapid Exchange Embolic Protection System (Generation 5). The remaining subjects will be treated with the FDA approved Emboshield® BareWire™ Rapid Exchange Embolic Protection System (Generation 3).
Primary Outcome Measure Information:
Title
Kaplan-Meier Estimate of Freedom From the Composite of Any Death, Stroke and MI During the 30 Day Post Procedural Period (DSMI), Plus Fatal and Non-fatal Ipsilateral Stroke From 31-365 Days and Annually Thereafter for a Total of 3 Years.
Description
Freedom from DSMI to 30 days or ipsilateral stroke from 31 days to 3 years. KM event free (%) curve.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Acute Device Success
Description
Defined by the attainment of <50% residual stenosis covering an area no longer than the original lesion treated with the stent.
Time Frame
Post-procedure
Title
Procedural Success
Description
Defined as the attainment of less than 50% residual stenosis (per angiographic core lab) of the target lesion and the absence of DSMI at 30 days post-index procedure.
Time Frame
30 Days
Title
Composite of Any Transient Ischemic Attack (TIA) and Amaurosis Fugax
Description
Includes only each subject's first occurrence of each event.
Time Frame
≤30 days
Title
Kapan-Meier Estimate of Freedom From Clinically Driven Target Lesion Revascularization Through Three Years.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Subject must be ≥ 18 years of age. Subject has the ability to cooperate with study procedures and agrees to return for all required follow-up visits, tests and exams. Female subjects of childbearing potential must have a documented negative pregnancy test within 30 days prior to the index procedure. Subjects taking warfarin may be included if their dosage is reduced before the index procedure to result in an INR of 1.5 or less. Warfarin may be restarted to therapeutic dose after the index procedure. The subject must sign a written informed consent prior to the initiation of any study procedures, using a form that is approved by the Institutional Review Board (IRB) or Medical Ethics Committee (EC). The life expectancy of the subject is at least two years. The subject has a lesion located in the internal carotid artery (ICA); the carotid bifurcation may be involved. The target lesion is intended to be treated with a single stent. Target ICA vessel diameter must be visually estimated to be: ≥2.5 mm and ≤7.0 for the Emboshield Pro (Gen 5) ≥ 2.8 mm and ≤6.2 for the Emboshield (Gen 3) And ≥4.0 mm and ≤9.0 mm for the Xact Stent treatment area. The subject has a carotid artery stenosis determined by ultrasound or angiography (visual estimate) to be: ≥50% for symptomatic subjects Or ≥80% for asymptomatic subjects High-risk inclusion criteria for either anatomical or co-morbid risk factors are present. The subject must fulfill at least one of the criteria, Category I or II risk factors, listed below to meet the inclusion criteria. Category I Anatomic Risk Factors Previous radiation treatment to the neck or radical neck dissection Target lesion is at or above the second vertebral body C2 (level of jaw) Inability to extend the head due to cervical arthritis or other cervical disorders Tracheostomy or tracheal stoma Laryngectomy Contralateral laryngeal nerve palsy Severe tandem lesions Category II Co-morbid Risk Factors Previous CEA with significant restenosis (as defined for symptomatic or asymptomatic subjects) Total occlusion of the contralateral carotid artery Left ventricular ejection fraction < 35% Congestive Heart failure New York Heart Association (NYHA) Functional Class III or higher Dialysis dependent renal failure Canadian Cardiovascular Society Angina Classification III or higher or unstable angina Requires coronary artery bypass surgery, cardiac valve surgery, peripheral vascular surgery, or abdominal aortic aneurysm repair within 60 days •≥80 years of age Myocardial infarction within previous 6 weeks Abnormal stress test. Treadmill, thallium or dobutamine echo are acceptable. The stress tests should be sufficiently abnormal to place the subject at increased risk for CEA. This includes subjects with two or more proximal diseased coronary arteries of >70% stenosis that have not or cannot be revascularized or <30 days since revascularization. Severe pulmonary disease, including at least one of the following: requires chronic O2 therapy; resting PO2 ≤60 mm Hg, Hematocrit ≥50%, FEV₁ or DLCO ≤50% of normal. Exclusion Criteria The subject is participating in another investigational trial that would interfere with the conduct or result of this study. The subject has dementia or a neurological illness that may confound the neurological evaluation. Total occlusion of the target vessel. There is an existing, previously placed stent in the target artery. The subject has a known life-threatening allergy to the contrast media that cannot be treated. 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 or aspirin and Ticlopidine. The subject has a GI bleed that would interfere with antiplatelet therapy. The subject has known cardiac sources of emboli, including but not limited to current or past history of paroxysmal or sustained atrial fibrillation (treated or untreated), valve replacement, etc. Subject has Hemoglobin (Hgb) less than 8 gm/dL (unless on dialysis), platelet count <50,000/mm3, or known heparin associated thrombocytopenia. The subject has a history of bleeding diathesis or coagulopathy including thrombocytopenia or an inability to receive heparin or Bivalirudin (Angiomax™) in amounts sufficient to maintain an ACT of >250, or will refuse blood transfusion. The subject has atherosclerotic disease involving adjoining vessels that precludes safe placement of the guiding catheter or sheath. The subject has other abnormal angiographic findings that indicate the subject is at risk for a stroke due to a problem other than that of the target lesion, such as: ipsilateral arterial stenosis greater in severity than the target lesion, cerebral aneurysm, or arteriovenous malformation of the cerebral vasculature. There is evidence of a carotid artery dissection prior to the initiation of the index procedure. There is an angiographically visible thrombus. There is any condition that precludes proper angiographic assessment, placement of the cerebral protective system or makes percutaneous arterial access unsafe, e.g. morbid obesity, sustained systolic blood pressure >180 mm Hg, tortuosity, occlusive disease, vessel anatomy, or aortic arch anatomy. Occlusion (TIMI 0 flow), or string sign of the ipsilateral common or internal carotid artery. There is evidence of bilateral carotid stenosis that would require intervention within 30 days of the index procedure. There is evidence of a stroke within the previous 30 days of the index procedure. There is a planned treatment of a non-target lesion within 30 days post-index procedure. There is a history of intracranial hemorrhage within the previous 3 months, including hemorrhagic transformation of an ischemic stroke. There is a history of an ipsilateral stroke with fluctuating neurologic symptoms within one year of the index procedure.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seemant Chaturvedi, MD
Organizational Affiliation
Wayne State University Stroke Program
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
William A Gray, MD
Organizational Affiliation
Columbia University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jon Matsumura, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Study Chair
Facility Information:
Facility Name
Washington Hospital
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
El Camino Hospital
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
Hoag Memorial Hospital Presbyterian
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Facility Name
Memorial Hospital Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Lakeland Regional Medical Center
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Munroe Regional Medical Center
City
Ocala
State/Province
Florida
ZIP/Postal Code
34475
Country
United States
Facility Name
Hawaii Permanente Medical Group-Kaiser Foundation Hospital
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96819
Country
United States
Facility Name
Northwestern University Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
St. John's Hospital / Memorial Medical Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
Country
United States
Facility Name
Parkview Hospital
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46805
Country
United States
Facility Name
St. Vincent Hospital and Health Care Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Terrebonne General Medical Center
City
Houma
State/Province
Louisiana
ZIP/Postal Code
70360
Country
United States
Facility Name
Washington Adventist Hospital
City
Takoma Park
State/Province
Maryland
ZIP/Postal Code
20912
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
St. Joseph Mercy Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
McLaren Regional Medical Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48532
Country
United States
Facility Name
Genesys Regional Medical Center
City
Grand Blanc
State/Province
Michigan
ZIP/Postal Code
48439
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Our Lady of Lourdes Medical Center
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
St. Michael's Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07102
Country
United States
Facility Name
Millard Fillmore Hospital-Kaleida Health Systems
City
Buffalo
State/Province
New York
ZIP/Postal Code
14209
Country
United States
Facility Name
Lenox Hill Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
WakeMed Hospital
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27610
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Lehigh Valley Hospital
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18105
Country
United States
Facility Name
Pinnacle Health Hospital
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17110
Country
United States
Facility Name
St. Joseph's Medical center
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Greenville Memorial Medical Center
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Holston Valley Medical Center
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Mercy Medical Center West / Baptist Hospital of East Tennessee
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37934
Country
United States
Facility Name
Austin Heart P.A.
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Presbyterian Heart Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
St. Luke's Episcopal Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Chesapeake General Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Bon Secours St. Mary's Hospital
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
Facility Name
St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/22236885
Description
Results of carotid artery stenting with distal embolic protection with improved systems: Protected Carotid Artery Stenting in Patients at High Risk for Carotid Endarterectomy (PROTECT) trial.

Learn more about this trial

Protected Carotid Artery Stenting in Subjects at High Risk for Carotid Endarterectomy (CEA) (PROTECT)

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