CABANA: A Carotid Stenting Boston Scientific Surveillance Program

• Sponsor: Boston Scientific Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00741091
• Collaborator: (none)
• Enrollment: 1,097
• Locations: 112
• Arm: 1
• Duration (Months): 22
• Patients Per Site: 9.8
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

CABANA is a multicenter U.S. surveillance registry that will be conducted to compile early clinical outcomes data for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice and to assess the adequacy of the Boston Scientific Corporation (BSC) Carotid Stenting Training Program.

Condition or Disease	Intervention/Treatment	Phase
Carotid Artery Disease	Device: Carotid WALLSTENT Monorail Endoprosthesis; Device: FilterWire EZ™ System™	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 1097 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Carotid Stenting Boston Scientific Surveillance Program Carotid WALLSTENT Monorail Endoprosthesis FilterWire EZ™ Embolic Protection System
• Study Start Date: Dec 1, 2008
• Actual Primary Completion Date: Oct 1, 2010
• Actual Study Completion Date: Oct 1, 2010

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Registry Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.

Device: Carotid WALLSTENT Monorail Endoprosthesis; A carotid artery stent for use in subjects at high risk for adverse events from Carotid endarterectomy (CEA) due to either anatomic or comorbid conditions who require carotid revascularization in the treatment of ipsilateral or bilateral carotid artery disease.; Device: FilterWire EZ™ System™; Embolic protection device used in conjunction with the Carotid WALLSTENT Endoprosthesis.

Outcome Measures

Primary Outcome Measures

1. Composite of Major Adverse Events (MAE) Defined as Center-reported and Clinical Events Committee (CEC) Adjudicated Death, Stroke, and Myocardial Infarction (MI) [30 days]

   Number of participants who experienced a major adverse event (MAE) 0-30 days post-procedure. MAE was defined as add death, stroke, and myocardial infarction(MI).

Secondary Outcome Measures

1. Number of Participants With Device, Procedure, and Unrelated Adverse Events (AEs) [30 days]

   Adverse events, serious and non-serious, were reported by all study centers. Device related adverse events were defined as any adverse event related the study device as determined by the (Principal Investigator)PI. Procedure related adverse events were defined as any adverse event related the study procedure as determine by the PI. Unrelated adverse events were determined by the PI to not be related to the study device or study procedure.

2. Target Lesion Revascularization [30 days]

   Number of participant with any surgical or percutaneous attempt to revascularize the target lesion after the initial treatment. The target lesion was defined as the stented segment including 0.5 cm at the proximal and distal margins of the stented segment.

3. System Technical Success [30 days]

   System technical success included successful delivery and deployment of the FilterWire EZ System beyond the target lesion site, delivery and deployment of the Carotid WALLSTENT Endoprosthesis at the intended location, and successful retrieval of the delivery catheter and FilterWire EZ System after stent placement. System technical success rates was calculated based on the number of participants who had both the FilterWire EZ System and Carotid WALLSTENT Endoprosthesis placement attempted.

4. Device Malfunction [30 days]

   Device Malfunction was defined as a failure of the device to meet performance specifications or otherwise perform as intended.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subject at high risk for adverse events from carotid endarterectomy due to either anatomic or comorbid conditions who requires carotid revascularization in the treatment of ipsilateral or bilateral carotid artery disease.

• Subject with neurological symptoms and greater than or equal to 50% stenosis of the common, internal carotid artery and/or the bifurcation by ultrasound or angiogram OR

• Subjects without neurological symptoms and greater than or equal to 80% stenosis of the common, internal carotid artery and/or the bifurcation by ultrasound or angiogram.

• Subject has a reference vessel diameter greater than or equal to 4.0 mm and less than or equal to 9.0 mm at the target lesion and a vessel diameter distal to the target lesion of greater than or equal to 3.5 mm and less than or equal to 5.5 mm as optimal "landing zone" for placement of the FilterWire EZ System.

• Subject is willing and able to comply with all follow-up requirements.

• Subject has provided a signed informed consent prior to participation in the Registry.

Exclusion Criteria:

• Patients in whom anticoagulant and/or antiplatelet therapy is contraindicated

• Patients with severe vascular tortuosity or anatomy that would preclude the safe introduction of a guide catheter, sheath, embolic protection system or stent system

• Patients with uncorrected bleeding disorders

• Lesions in the ostium of the common carotid artery.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Baptist Medical Center Princeton	Birmingham	Alabama	United States	35211
2	Cardiology Associates of Mobile	Fairhope	Alabama	United States	36532
3	St. Joseph's Hospital and Medical Center, Barrow Neurological Institute	Phoenix	Arizona	United States	85013
4	Southern Arizona Vascular Institute	Tucson	Arizona	United States	85741
5	University of Arkansas	Little Rock	Arkansas	United States	72205
6	Central Cardiology Medical Clinic	Bakersfield	California	United States	93308
7	Los Angeles Cardiology Associates	Los Angeles	California	United States	90017
8	Ronald Reagan UCLA Medical Center	Los Angeles	California	United States	90095
9	Hoag Hospital	Newport Beach	California	United States	92663
10	VA Palo Alto Health Care System	Palo Alto	California	United States	94304
11	Salinas Valley Memorial Healthcare System	Salinas	California	United States	93907
12	University of California, San Francisco	San Francisco	California	United States	94143
13	St. Joseph's Medical Center	Stockton	California	United States	95204
14	San Ramon Regional Medical Center	Walnut Creek	California	United States	94598
15	University of Colorado Hospital	Aurora	Colorado	United States	80045
16	University of Connecticut Health Center	Farmington	Connecticut	United States	06030
17	Waterbury Hospital	Waterbury	Connecticut	United States	06708
18	Christiana Care Cardiovascular Research	Newark	Delaware	United States	19718
19	JFK Medical Center	Atlantis	Florida	United States	33462
20	Delray Medical Center	Boca Raton	Florida	United States	33487
21	Bethesda Memorial Hospital	Boynton Beach	Florida	United States	33435
22	Bradenton Cardiology	Bradenton	Florida	United States	34205
23	Jim Moran Heart and Vascular Research Institute	Fort Lauderdale	Florida	United States	33308
24	University of Florida	Gainesville	Florida	United States	32611
25	Aventura Hospital	Hollywood	Florida	United States	33021
26	University of Miami Hospital	Miami	Florida	United States	33136
27	Baptist Hospital of Miami	Miami	Florida	United States	33176
28	MediQuest Research Group Inc at Munroe Regional Medical Center	Ocala	Florida	United States	34471
29	Tallahassee Research Institute, Inc.	Tallahassee	Florida	United States	32308
30	Emory University Hospital	Atlanta	Georgia	United States	30308
31	Piedmont Hospital	Atlanta	Georgia	United States	30309
32	St. Joseph's Research Institute	Atlanta	Georgia	United States	30342
33	Vascular Surgical Associates PC	Austell	Georgia	United States	30106
34	Advocate Christ Medical Center	Oak Lawn	Illinois	United States	60453
35	Peoria Radiology Research & Education Foundation	Peoria	Illinois	United States	61637
36	St. John's Hospital, Prairie Education and Research Cooperative	Springfield	Illinois	United States	62701
37	Southern Illinois University - Memorial Medical Center	Springfield	Illinois	United States	62702
38	Indiana University School of Medicine	Indianapolis	Indiana	United States	46202
39	The Indiana Heart Hospital	Indianapolis	Indiana	United States	46250
40	Norton Hospital	Louisville	Kentucky	United States	40202
41	Physicians and Surgeons Surgical Hospital	Monroe	Louisiana	United States	71201
42	Ochsner Clinic Foundation	New Orleans	Louisiana	United States	70121
43	Opelousas General Health Center	Opelousas	Louisiana	United States	70570
44	Southern Maryland Hospital Center	Clinton	Maryland	United States	20735
45	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
46	University of Michigan	Ann Arbor	Michigan	United States	48109
47	Michigan Vascular Research Center	Flint	Michigan	United States	48507
48	Northern Michigan Hospital	Petoskey	Michigan	United States	49770
49	Covenant Medical Center	Saginaw	Michigan	United States	48602
50	Great Lakes Heart and Vascular	St. Joseph	Michigan	United States	49085
51	North Memorial Medical Center	Robbinsdale	Minnesota	United States	55422
52	Freeman Heart & Vascular Institute	Joplin	Missouri	United States	64804
53	St. John's Regional Medical Center	Joplin	Missouri	United States	64804
54	St. Joseph Medical Center	Kansas City	Missouri	United States	64114
55	The Cardiac Center of Creighton University	Omaha	Nebraska	United States	68131
56	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire	United States	03756
57	Cooper University Hospital	Camden	New Jersey	United States	08103
58	Our Lady of Lourdes Medical Center	Cherry Hill	New Jersey	United States	08034
59	UMDNJ-Robert Wood Johnson Medical School	New Brunswick	New Jersey	United States	08903
60	St. Michael's Medical Center	Newark	New Jersey	United States	07102
61	Overlook Hospital	Short Hills	New Jersey	United States	07078
62	New Mexico Heart Institute, PA	Albuquerque	New Mexico	United States	82102
63	Albany Medical Center Hospital	Albany	New York	United States	12208
64	Maimonides Medical Center	Brooklyn	New York	United States	11219
65	Kaleida Health	Buffalo	New York	United States	14209
66	Mercy Hospital of Buffalo	Buffalo	New York	United States	14221
67	St. Joseph Hospital	Liverpool	New York	United States	13088
68	Mount Sinai Medical Center	New York	New York	United States	10029
69	Stony Brook University Medical Center	Stony Brook	New York	United States	11794
70	Wake Medical Center	Raleigh	North Carolina	United States	27610
71	Forsyth Medical Center	Winston-Salem	North Carolina	United States	27103
72	Bethesda North Hospital	Cincinnati	Ohio	United States	45242
73	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
74	Riverside Methodist Hospital	Columbus	Ohio	United States	43214
75	Grant Medical Center	Columbus	Ohio	United States	43215
76	Southern Ohio Medical Center	Portsmouth	Ohio	United States	45662
77	Mercy St. Vincent	Toledo	Ohio	United States	43608
78	University of Toledo Medical Center	Toledo	Ohio	United States	43614
79	Lake West Hospital	Willoughby	Ohio	United States	44094
80	Oregon Stroke Center	Portland	Oregon	United States	97239
81	Lehigh Valley Hospital	Allentown	Pennsylvania	United States	18105
82	Central PA Cardiovascular Research Institute	Harrisburg	Pennsylvania	United States	17110
83	Pennsylvania Hospital of the University of Pennsylvania Health System	Philadelphia	Pennsylvania	United States	19106
84	Pinnacle Health at Harrisburg Hospital	Wormleysburg	Pennsylvania	United States	17043
85	Berks Cardiologists, Ltd.	Wyomissing	Pennsylvania	United States	19610
86	St. Mary Medical Center	Yardley	Pennsylvania	United States	19067
87	York Hospital	York	Pennsylvania	United States	17403
88	Rhode Island Hospital	Providence	Rhode Island	United States	02905
89	Medical University of South Carolina	Charleston	South Carolina	United States	29425
90	South Carolina Heart Center	Columbia	South Carolina	United States	29204
91	University Medical Center - Greenville Memorial Hospital	Greenville	South Carolina	United States	29605
92	Sanford USD Medical Center - Sanford Clinical Research	Sioux Falls	South Dakota	United States	57105
93	Erlanger Hospital	Chattanooga	Tennessee	United States	37403
94	Memorial Hospital	Chattanooga	Tennessee	United States	37404
95	Cardiovascular Associates PC	Kingsport	Tennessee	United States	37660
96	University of Tennessee Medical Center	Knoxville	Tennessee	United States	37920
97	Baptist Hospital West	Knoxville	Tennessee	United States	37934
98	Baptist Memorial Hospital-Memphis	Memphis	Tennessee	United States	38120
99	Cardiothoracic and Vascular Surgeons (CTVS)	Austin	Texas	United States	78756
100	Medical City Dallas Hospital	Dallas	Texas	United States	75230
101	Presbyterian Hospital of Dallas	Dallas	Texas	United States	75231
102	University of Texas Medical Branch	Galveston	Texas	United States	77555
103	St. Luke's Episcopal Hospital	Houston	Texas	United States	77030
104	The Methodist Hospital	Houston	Texas	United States	77030
105	The Heart Hospital Baylor Plano	Plano	Texas	United States	75024
106	Peripheral Vascular Associates	San Antonio	Texas	United States	78205
107	University of Texas Health Science Center San Antonio	San Antonio	Texas	United States	78229
108	Inova Fairfax Hospital	Falls Church	Virginia	United States	22042
109	Sentara Norfolk General Hospital	Norfolk	Virginia	United States	23507
110	Swedish Medical Center	Seattle	Washington	United States	98122
111	St. Joseph Hospital	Tacoma	Washington	United States	98405
112	Aurora St. Luke's Medical Center	Milwaukee	Wisconsin	United States	53233

Sponsors and Collaborators

• Boston Scientific Corporation

Investigators

• Study Director: Pamela Grady, Ph.D, Boston Scientific Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT00741091
• Other Study ID Numbers: S2029
• First Posted: Aug 26, 2008
• Last Update Posted: Aug 24, 2011
• Last Verified: Aug 1, 2011

• Keywords provided by Boston Scientific Corporation: Cerebrovascular Disease; Carotid Stent; Stent; Carotid Endarterectomy (CEA)
• Additional relevant MeSH terms: Carotid Artery Diseases

Study Results

Participant Flow

Recruitment Details	Enrollment began on 17 December 2008. Enrollment was completed on 28 September 2010.

Arm/Group Title	Carotid WALLSTENT Endoprothesis and FilterWire EZ System
Arm/Group Description	Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.
Period Title: Overall Study
STARTED	1097
COMPLETED	1040
NOT COMPLETED	57

Baseline Characteristics

Arm/Group Title	Carotid WALLSTENT Endoprothesis and FilterWire EZ System
Arm/Group Description	Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.
Overall Participants	1097
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	71.3 (9.2)
Sex: Female, Male (Count of Participants)
Female	414 37.7%
Male	683 62.3%
Region of Enrollment (participants) [Number]
United States	1097 100%

Outcome Measures

1. Primary Outcome

Title	Composite of Major Adverse Events (MAE) Defined as Center-reported and Clinical Events Committee (CEC) Adjudicated Death, Stroke, and Myocardial Infarction (MI)
Description	Number of participants who experienced a major adverse event (MAE) 0-30 days post-procedure. MAE was defined as add death, stroke, and myocardial infarction(MI).
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

All 1097 enrolled participants were considered for analysis. A total of 1025 subjects were evaluable for MAEs. Seventy two participants were not evaluable for MAEs; 32 participants were not evaluable because the follow-up occurred less than 23 days from enrollment and 40 participants did not complete the expected follow-up.

Arm/Group Title	Carotid WALLSTENT Endoprothesis and FilterWire EZ System
Arm/Group Description	Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.
Measure Participants	1025
Number [Participants]	47 4.3%

2. Secondary Outcome

Title	Number of Participants With Device, Procedure, and Unrelated Adverse Events (AEs)
Description	Adverse events, serious and non-serious, were reported by all study centers. Device related adverse events were defined as any adverse event related the study device as determined by the (Principal Investigator)PI. Procedure related adverse events were defined as any adverse event related the study procedure as determine by the PI. Unrelated adverse events were determined by the PI to not be related to the study device or study procedure.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Carotid WALLSTENT Endoprothesis and FilterWire EZ System
Arm/Group Description	Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.
Measure Participants	1097
Participants with Device Related AEs	139 12.7%
Participants with Procedure Related AEs	486 44.3%
Participants with Unrelated AEs	390 35.6%

3. Secondary Outcome

Title	Target Lesion Revascularization
Description	Number of participant with any surgical or percutaneous attempt to revascularize the target lesion after the initial treatment. The target lesion was defined as the stented segment including 0.5 cm at the proximal and distal margins of the stented segment.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Carotid WALLSTENT Endoprothesis and FilterWire EZ System
Arm/Group Description	Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.
Measure Participants	1097
Number [Participants]	0 0%

4. Secondary Outcome

Title	System Technical Success
Description	System technical success included successful delivery and deployment of the FilterWire EZ System beyond the target lesion site, delivery and deployment of the Carotid WALLSTENT Endoprosthesis at the intended location, and successful retrieval of the delivery catheter and FilterWire EZ System after stent placement. System technical success rates was calculated based on the number of participants who had both the FilterWire EZ System and Carotid WALLSTENT Endoprosthesis placement attempted.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

To be evaluable for system technical success, subjects needed to have a Carotid WALLSTENT deployment attempted.

Arm/Group Title	Carotid WALLSTENT Endoprothesis and FilterWire EZ System
Arm/Group Description	Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.
Measure Participants	1072
Number [Participants]	1041 94.9%

5. Secondary Outcome

Title	Device Malfunction
Description	Device Malfunction was defined as a failure of the device to meet performance specifications or otherwise perform as intended.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Carotid WALLSTENT Endoprothesis and FilterWire EZ System
Arm/Group Description	Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.
Measure Participants	1097
Number [Devices]	61

Adverse Events

Time Frame	30-day major adverse events (MAE) are defined as all deaths, strokes, and myocardial infarctions (MIs) that occur within 0-30 days post-procedure.
Adverse Event Reporting Description	Patients were also evaluated for adverse events during the procedure and at hospital discharge
Arm/Group Title	Carotid WALLSTENT Endoprothesis and FilterWire EZ System
Arm/Group Description	Registry to gather data on early clinical outcomes for the Carotid WALLSTENT Endoprosthesis and FilterWire EZ System in routine clinical practice.
All Cause Mortality
	Carotid WALLSTENT Endoprothesis and FilterWire EZ System
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Carotid WALLSTENT Endoprothesis and FilterWire EZ System
	Affected / at Risk (%)	# Events
Total	230/1097 (21%)
Blood and lymphatic system disorders
Anaemia	16/1097 (1.5%)	16
Thrombocytopenia	2/1097 (0.2%)	2
Cardiac disorders
Acute coronary syndrome	1/1097 (0.1%)	1
Angina pectoris	8/1097 (0.7%)	9
Angina unstable	1/1097 (0.1%)	1
Arrhythmia	1/1097 (0.1%)	1
Atrial fibrillation	4/1097 (0.4%)	4
Atrial flutter	2/1097 (0.2%)	2
Atrioventricular block first degree	1/1097 (0.1%)	1
Atrioventricular block second degree	1/1097 (0.1%)	1
Bradycardia	14/1097 (1.3%)	14
Cardiac arrest	5/1097 (0.5%)	5
Cardiac failure	3/1097 (0.3%)	3
Cardiac failure congestive	7/1097 (0.6%)	8
Cardio-respiratory arrest	1/1097 (0.1%)	1
Coronary artery disease	1/1097 (0.1%)	1
Myocardial infarction	5/1097 (0.5%)	5
Sick sinus syndrome	1/1097 (0.1%)	1
Sinus arrest	1/1097 (0.1%)	1
Sinus bradycardia	1/1097 (0.1%)	1
Ventricular tachycardia	1/1097 (0.1%)	1
Eye disorders
Blindness	1/1097 (0.1%)	1
Blindness transient	1/1097 (0.1%)	1
Diplopia	1/1097 (0.1%)	1
Eye pain	1/1097 (0.1%)	1
Retinal artery occlusion	1/1097 (0.1%)	1
Gastrointestinal disorders
Abdominal pain	2/1097 (0.2%)	2
Colitis	1/1097 (0.1%)	1
Dysphagia	1/1097 (0.1%)	1
Gastritis	1/1097 (0.1%)	1
Gastrointestinal haemorrhage	4/1097 (0.4%)	4
Gastrointestinal ulcer	1/1097 (0.1%)	1
Ileus paralytic	1/1097 (0.1%)	1
Intestinal obstruction	1/1097 (0.1%)	1
Mallory-Weiss syndrome	1/1097 (0.1%)	1
Melaena	1/1097 (0.1%)	1
Nausea	5/1097 (0.5%)	5
Oesophagitis	1/1097 (0.1%)	1
Retroperitoneal haemorrhage	1/1097 (0.1%)	1
Umbilical hernia	1/1097 (0.1%)	1
General disorders
Vomiting	2/1097 (0.2%)	2
Adverse drug reaction	3/1097 (0.3%)	3
Asthenia	4/1097 (0.4%)	4
Catheter site discharge	2/1097 (0.2%)	2
Catheter site haematoma	5/1097 (0.5%)	5
Catheter site haemorrhage	1/1097 (0.1%)	1
Catheter site related reaction	2/1097 (0.2%)	2
Chills	1/1097 (0.1%)	1
Death	1/1097 (0.1%)	1
Fatigue	1/1097 (0.1%)	1
Gait disturbance	1/1097 (0.1%)	1
Generalised oedema	1/1097 (0.1%)	1
Multi-organ failure	1/1097 (0.1%)	1
Non-cardiac chest pain	3/1097 (0.3%)	3
Pyrexia	3/1097 (0.3%)	3
Hepatobiliary disorders
Cholecystitis	2/1097 (0.2%)	2
Immune system disorders
Anaphylactic reaction	1/1097 (0.1%)	1
Infections and infestations
Appendicitis	1/1097 (0.1%)	1
Catheter site infection	1/1097 (0.1%)	1
Cellulitis	2/1097 (0.2%)	2
Clostridium difficile colitis	2/1097 (0.2%)	2
Gastroenteritis	1/1097 (0.1%)	1
Kidney infection	1/1097 (0.1%)	1
Pneumonia	7/1097 (0.6%)	7
Pneumonia bacterial	1/1097 (0.1%)	1
Pneumonia staphylococcal	2/1097 (0.2%)	2
Sepsis	2/1097 (0.2%)	2
Staphylococcal infection	2/1097 (0.2%)	2
Urinary tract infection	7/1097 (0.6%)	7
Injury, poisoning and procedural complications
Abdominal wound dehiscence	1/1097 (0.1%)	1
Brain herniation	1/1097 (0.1%)	1
Fall	1/1097 (0.1%)	1
Femur fracture	1/1097 (0.1%)	1
Head injury	1/1097 (0.1%)	1
Incision site haematoma	1/1097 (0.1%)	1
Joint sprain	1/1097 (0.1%)	1
Procedural hypertension	1/1097 (0.1%)	1
Procedural hypotension	1/1097 (0.1%)	2
Vascular pseudoaneurysm	2/1097 (0.2%)	2
Investigations
Blood creatinine increased	2/1097 (0.2%)	2
Blood pressure increased	1/1097 (0.1%)	1
Cardiac stress test abnormal	1/1097 (0.1%)	1
Electrocardiogram change	2/1097 (0.2%)	2
Haematocrit decreased	2/1097 (0.2%)	2
Haemoglobin abnormal	1/1097 (0.1%)	1
Haemoglobin decreased	4/1097 (0.4%)	4
Troponin increased	2/1097 (0.2%)	2
Metabolism and nutrition disorders
Diabetic ketoacidosis	1/1097 (0.1%)	1
Hyperglycaemia	2/1097 (0.2%)	2
Hyperkalaemia	1/1097 (0.1%)	1
Hypoglycaemia	1/1097 (0.1%)	1
Hyponatraemia	1/1097 (0.1%)	1
Musculoskeletal and connective tissue disorders
Back pain	1/1097 (0.1%)	1
Muscular weakness	2/1097 (0.2%)	2
Neck pain	1/1097 (0.1%)	1
Pain in extremity	1/1097 (0.1%)	1
Sensation of heaviness	1/1097 (0.1%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified recurrent	1/1097 (0.1%)	1
Lung carcinoma cell type unspecified stage III	1/1097 (0.1%)	1
Nervous system disorders
Aphasia	1/1097 (0.1%)	1
Carotid artery occlusion	1/1097 (0.1%)	1
Carotid artery thrombosis	2/1097 (0.2%)	3
Cerebral artery thrombosis	1/1097 (0.1%)	1
Cerebral haemorrhage	1/1097 (0.1%)	2
Cerebral infarction	1/1097 (0.1%)	1
Cerebrovascular accident	25/1097 (2.3%)	25
Convulsion	6/1097 (0.5%)	6
Dizziness	1/1097 (0.1%)	1
Haemorrhage intracranial	1/1097 (0.1%)	1
Haemorrhagic stroke	3/1097 (0.3%)	4
Headache	3/1097 (0.3%)	3
Hemiparesis	3/1097 (0.3%)	3
Hemiplegia	1/1097 (0.1%)	1
Hepatic encephalopathy	1/1097 (0.1%)	1
Hypoaesthesia	1/1097 (0.1%)	1
Ischaemic stroke	1/1097 (0.1%)	1
Presyncope	1/1097 (0.1%)	1
Sensory disturbance	1/1097 (0.1%)	1
Somnolence	1/1097 (0.1%)	1
Subarachnoid haemorrhage	1/1097 (0.1%)	1
Syncope	1/1097 (0.1%)	1
Syncope vasovagal	2/1097 (0.2%)	2
Transient ischaemic attack	9/1097 (0.8%)	9
Tremor	1/1097 (0.1%)	1
Psychiatric disorders
Confusional state	2/1097 (0.2%)	2
Delirium	1/1097 (0.1%)	1
Disorientation	1/1097 (0.1%)	1
Mental status changes	3/1097 (0.3%)	3
Renal and urinary disorders
Haematuria	1/1097 (0.1%)	1
Renal artery stenosis	1/1097 (0.1%)	1
Renal failure	2/1097 (0.2%)	2
Renal failure acute	5/1097 (0.5%)	5
Renal failure chronic	1/1097 (0.1%)	1
Ureteric obstruction	1/1097 (0.1%)	1
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema	2/1097 (0.2%)	2
Acute respiratory failure	1/1097 (0.1%)	1
Aspiration	2/1097 (0.2%)	2
Choking	1/1097 (0.1%)	1
Chronic obstructive pulmonary disease	4/1097 (0.4%)	4
Cough	1/1097 (0.1%)	1
Dyspnoea	5/1097 (0.5%)	6
Interstitial lung disease	1/1097 (0.1%)	1
Pleural effusion	3/1097 (0.3%)	3
Pleuritic pain	1/1097 (0.1%)	1
Pneumonia aspiration	2/1097 (0.2%)	2
Pneumothorax	1/1097 (0.1%)	1
Pulmonary congestion	1/1097 (0.1%)	1
Respiratory arrest	1/1097 (0.1%)	1
Respiratory distress	1/1097 (0.1%)	1
Respiratory failure	3/1097 (0.3%)	3
Wheezing	1/1097 (0.1%)	1
Skin and subcutaneous tissue disorders
Skin ulcer	1/1097 (0.1%)	1
Surgical and medical procedures
Toe amputation	1/1097 (0.1%)	1
Vascular disorders
Aortic aneurysm	1/1097 (0.1%)	1
Arterial spasm	2/1097 (0.2%)	2
Arterial thrombosis limb	1/1097 (0.1%)	1
Deep vein thrombosis	3/1097 (0.3%)	3
Haemorrhage	1/1097 (0.1%)	1
Hypertension	4/1097 (0.4%)	4
Hypotension	48/1097 (4.4%)	48
Iliac artery stenosis	1/1097 (0.1%)	1
Orthostatic hypotension	3/1097 (0.3%)	4
Peripheral vascular disorder	1/1097 (0.1%)	2
Shock	1/1097 (0.1%)	1
Temporal arteritis	1/1097 (0.1%)	1
Vasospasm	1/1097 (0.1%)	1
Other (Not Including Serious) Adverse Events
	Carotid WALLSTENT Endoprothesis and FilterWire EZ System
	Affected / at Risk (%)	# Events
Total	332/1097 (30.3%)
Cardiac disorders
Bradycardia	94/1097 (8.6%)	97
General disorders
Catheter site haematoma	69/1097 (6.3%)	71
Catheter site haemorrhage	57/1097 (5.2%)	59
Nervous system disorders
Headache	58/1097 (5.3%)	59
Vascular disorders
Hypotension	162/1097 (14.8%)	168

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The disclosure restriction on the PI is that the Sponsor can review results communications prior to public release and can embargo communication regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the Sponsor for review. The Sponsor can require changes to the communication to remove any confidential information or other proprietary information of Sponsor.