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

• ClinicalTrials.gov Identifier: NCT00402740
• Recruitment Status: Completed
• First Posted: November 22, 2006
• Results First Posted: June 20, 2012
• Last Update Posted: June 20, 2012
• Sponsor: Abbott Medical Devices
• Information provided by (Responsible Party): Abbott Medical Devices

• Study Type: Interventional
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Carotid Artery Disease
• Intervention: Device: Xact Stent with either Emboshield Pro (Gen 5) or Emboshield (Gen 3)
• Enrollment: 322

Participant Flow

Recruitment Details	A total of 322 subjects were enrolled in the PROTECT study at 38 clinical sites in the United States. The first subject was enrolled on November 29, 2006, and enrollment was completed on June 18, 2008.
Pre-assignment Details

Arm/Group Title	Group 1
Arm/Group Description	[Not Specified]
Period Title: Overall Study
Started	322
Completed	242
Not Completed	80
Reason Not Completed
Withdrawal by Subject	18
Death	50
Lost to Follow-up	6
No stent. Completed FU at 30 days.	5
Subject disposition unknown.	1

Baseline Characteristics

Arm/Group Title		Group 1
Arm/Group Description		[Not Specified]
Overall Number of Baseline Participants		322
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	322 participants
	<=18 years	0 0.0%
	Between 18 and 65 years	71 22.0%
	>=65 years	251 78.0%
Age Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	322 participants
		72.7 (9.8)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	322 participants
	Female	115 35.7%
	Male	207 64.3%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	322 participants
		322

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Intent to Treat (ITT)

Arm/Group Title	Group 1
Arm/Group Description:	Includes only the most serious event for each subject and includes only each subject's first occurrence of the event.
Overall Number of Participants Analyzed	322
Measure Type: Number; Unit of Measure: Event-free percentage
	95.5

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Xact Stent	Emboshield Pro Gen 5	Emboshield Gen 3
Arm/Group Description:	The Xact stent success were counted per subject	Participants receiving Emboshield Pro Gen 5. Emboshield Pro success were counted per filter.	Participants receiving Emboshield Gen 3 Emboshield Gen3 success were counted per filter.
Overall Number of Participants Analyzed	317	222	101
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	98.7; (96.80 to 99.66)	97.3; (94.21 to 99.00)	97.0; (91.56 to 99.38)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Group 1
Arm/Group Description:	[Not Specified]
Overall Number of Participants Analyzed	322
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	95.30; (92.43 to 97.37)

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Group 1
Arm/Group Description:	[Not Specified]
Overall Number of Participants Analyzed	322
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	2.8; (1.29 to 5.24)

5. Secondary Outcome

Title	Kapan-Meier Estimate of Freedom From Clinically Driven Target Lesion Revascularization Through Three Years.
Description	[Not Specified]
Time Frame	3 years

Outcome Measure Data

Analysis Population Description

ITT

Arm/Group Title	Group 1
Arm/Group Description:	[Not Specified]
Overall Number of Participants Analyzed	317
Measure Type: Number; Unit of Measure: Event-free percentage
	98.2

Adverse Events

Time Frame	Three years post-procedure
Adverse Event Reporting Description	Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Arm/Group Title	Group 1
Arm/Group Description	[Not Specified]
All-Cause Mortality
	Group 1
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	Group 1
	Affected / at Risk (%)	# Events
Total	221/313 (70.61%)
Blood and lymphatic system disorders
Anemia † 1 [1]	27/313 (8.63%)	27
Leukopenia † 1 [1]	1/313 (0.32%)	1
Anemia † 1	8/313 (2.56%)	8
Cardiac disorders
Abnormal lab test † 1 [2]	1/313 (0.32%)	1
Angina † 1 [2]	10/313 (3.19%)	15
Arrhythmia † 1 [2]	30/313 (9.58%)	46
Cardiac arrest † 1 [2]	11/313 (3.51%)	11
Congestive heart failure † 1 [2]	30/313 (9.58%)	41
Coronary artery diseasee † 1 [2]	39/313 (12.46%)	51
Hypertensive cardiovascular disease † 1 [2]	1/313 (0.32%)	1
Myocardial infarctionsee † 1 [2]	13/313 (4.15%)	13
Structural heart disease † 1 [2]	14/313 (4.47%)	15
Hypotension † 1 [3]	6/313 (1.92%)	6
Myocardial infarction Non Q wave † 1 [4]	2/313 (0.64%)	2
Arrhythmia † 1 [5]	8/313 (2.56%)	8
Cardiac arrest † 1 [6]	1/313 (0.32%)	1
Gastrointestinal disorders
Gastrointestinal † 1 [7]	14/313 (4.47%)	15
Gastrointestinal † 1 [8]	32/313 (10.22%)	50
General disorders
Presyncope /syncope † 1 [3]	3/313 (0.96%)	3
Syncope † 1 [3]	6/313 (1.92%)	8
Urinary retention † 1 [9]	1/313 (0.32%)	1
Allergic reaction † 1 [8]	1/313 (0.32%)	1
Miscellaneous † 1 [8]	5/313 (1.60%)	5
Infections and infestations
Infection † 1 [8]	26/313 (8.31%)	33
Injury, poisoning and procedural complications
Hematoma † 1 [10]	2/313 (0.64%)	2
Occlusion † 1 [10]	2/313 (0.64%)	2
Other † 1 [7]	3/313 (0.96%)	3
Dissection † 1 [6]	1/313 (0.32%)	1
Fluid overload † 1 [6]	1/313 (0.32%)	1
Hypertension † 1 [11]	1/313 (0.32%)	1
Hypotension † 1 [6]	26/313 (8.31%)	26
Pain † 1 [12]	1/313 (0.32%)	1
Dissection † 1 [13]	1/313 (0.32%)	2
Instent restenosis † 1 [13]	7/313 (2.24%)	9
Metabolism and nutrition disorders
Metabolic † 1 [8]	14/313 (4.47%)	18
Musculoskeletal and connective tissue disorders
Musculoskeletal † 1 [8]	29/313 (9.27%)	33
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer † 1 [8]	26/313 (8.31%)	32
Nervous system disorders
Amaurosis fugax † 1 [14]	1/313 (0.32%)	1
Confusion † 1 [14]	2/313 (0.64%)	2
Hyperperfusion syndrome † 1 [14]	1/313 (0.32%)	1
Neurologic other † 1 [15]	21/313 (6.71%)	26
Seizure † 1 [14]	3/313 (0.96%)	4
Transient Ischemic Attack † 1	11/313 (3.51%)	12
Visual disturbance † 1 [16]	2/313 (0.64%)	4
Ipsilateral major † 1 [17]	3/313 (0.96%)	3
Ipsilateral minor † 1 [17]	8/313 (2.56%)	8
Psychiatric disorders
Mental health related † 1 [8]	1/313 (0.32%)	1
Trauma † 1 [8]	5/313 (1.60%)	6
Renal and urinary disorders
Hypertension † 1 [3]	9/313 (2.88%)	9
Genitourinarynal † 1 [8]	26/313 (8.31%)	34
Respiratory, thoracic and mediastinal disorders
Respiratory † 1 [8]	55/313 (17.57%)	91
Skin and subcutaneous tissue disorders
Subdural hematoma † 1 [14]	1/313 (0.32%)	1
Surgical and medical procedures
Epistaxis † 1 [7]	5/313 (1.60%)	5
Hematuria † 1 [7]	3/313 (0.96%)	3
Oropharyngeal † 1 [7]	1/313 (0.32%)	1
Vascular disorders
Aneurysm † 1 [13]	3/313 (0.96%)	3
Deep vein thrombosis † 1 [13]	4/313 (1.28%)	4
Peripheral vascular disease † 1 [13]	23/313 (7.35%)	30
Pseudoaneurysm † 1 [13]	1/313 (0.32%)	1
Restenosis † 1 [13]	1/313 (0.32%)	1
Stenosis † 1 [13]	11/313 (3.51%)	12
Thrombosis † 1 [13]	2/313 (0.64%)	2
Non-ipsilateral major † 1 [17]	5/313 (1.60%)	5
Non-ipsilateral minor † 1 [17]	4/313 (1.28%)	5
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, Abbott Categories; [1] Blood dyscrasia; [2] Cardiac; [3] Hemodynamic; [4] Myocardial infarction; [5] ?Procedure related? or neurological?; [6] Procedure related; [7] Bleeding; [8] Other; [9] ?Procedure related?; [10] Access site complication; [11] Procedural; [12] Procedure related?; [13] Vascular; [14] Neurologic other than stroke; [15] Neurologic other than stroke ??I'll require a little more information.; [16] ?? or eye disorders ??; [17] Stroke
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5.0%
	Group 1
	Affected / at Risk (%)	# Events
Total	236/313 (75.40%)
Blood and lymphatic system disorders
Anemia † 1	20/313 (6.39%)	23
Cardiac disorders
Arrhythmia † 1	25/313 (7.99%)	27
Arrhythmia † 1 [1]	22/313 (7.03%)	24
Hypotension † 1 [1]	43/313 (13.74%)	45
Gastrointestinal disorders
Other: Gastrointestinal † 1	48/313 (15.34%)	98
General disorders
Headache † 1 [1]	17/313 (5.43%)	18
Nausea/vomiting † 1 [1]	17/313 (5.43%)	17
Other: Genitourinary † 1	43/313 (13.74%)	63
Other: Metabolic † 1	28/313 (8.95%)	36
Other: Miscellaneous † 1 [2]	63/313 (20.13%)	118
Other: Trauma † 1	16/313 (5.11%)	17
Infections and infestations
Other: Infection † 1	31/313 (9.90%)	52
Injury, poisoning and procedural complications
Pain † 1 [1]	30/313 (9.58%)	36
Musculoskeletal and connective tissue disorders
Other: Musculoskeletal † 1	67/313 (21.41%)	122
Nervous system disorders
Neurologic other † 1 [3]	37/313 (11.82%)	51
Respiratory, thoracic and mediastinal disorders
Other: Respiratory † 1	55/313 (17.57%)	80
Vascular disorders
Peripheral vascular disease † 1 [1]	28/313 (8.95%)	34
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, Abbott Categories; [1] Procedure related; [2] ?? i'll need additional description; [3] ??Neurologic other than stroke?? I may need additional description

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Principal Investigator (PI), Institute, and Research Site (RS) acknowledge this is a multi-center study. An independent, joint publication is anticipated from investigators in the study, including the PI. Therefore, the PI, Institute, and RS agree not to publish or present the results before the publication of the multi-center investigator paper, but in no event shall PI, Institute, and/or RS be so restricted after the expiration of twelve months from completion of the Study at all sites.

Results Point of Contact

• Name/Title: Ellen Travis, MS, NFP
• Organization: Abbott Vascular
• Phone: 408 845-1512
• EMail: Ellen.Travis@av.abbott.com

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT00402740
• Other Study ID Numbers: 640-0071
• First Submitted: November 20, 2006
• First Posted: November 22, 2006
• Results First Submitted: May 7, 2012
• Results First Posted: June 20, 2012
• Last Update Posted: June 20, 2012