Trial Outcomes & Findings for Protected Carotid Artery Stenting in Subjects at High Risk for Carotid Endarterectomy (CEA) (PROTECT) (NCT NCT00402740)

NCT ID: NCT00402740

Last Updated: 2012-06-20

Results Overview

Freedom from DSMI to 30 days or ipsilateral stroke from 31 days to 3 years. KM event free (%) curve.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 322 participants
• Primary outcome timeframe: 3 years
• Results posted on: 2012-06-20

Participant Flow

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.

Participant milestones

Measure	Group 1
Overall Study STARTED	322
Overall Study COMPLETED	242
Overall Study NOT COMPLETED	80

Reasons for withdrawal

Measure	Group 1
Overall Study Withdrawal by Subject	18
Overall Study Death	50
Overall Study Lost to Follow-up	6
Overall Study No stent. Completed FU at 30 days.	5
Overall Study Subject disposition unknown.	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Group 1 n=322 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	71 Participants n=5 Participants
Age, Categorical >=65 years	251 Participants n=5 Participants
Age Continuous	72.7 years STANDARD_DEVIATION 9.8 • n=5 Participants
Sex: Female, Male Female	115 Participants n=5 Participants
Sex: Female, Male Male	207 Participants n=5 Participants
Region of Enrollment United States	322 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 years

Population: Intent to Treat (ITT)

Freedom from DSMI to 30 days or ipsilateral stroke from 31 days to 3 years. KM event free (%) curve.

Outcome measures

Measure	Group 1 n=322 Participants Includes only the most serious event for each subject and includes only each subject's first occurrence of the event.	Emboshield Pro Gen 5 Participants receiving Emboshield Pro Gen 5. Emboshield Pro success were counted per filter.	Emboshield Gen 3 Participants receiving Emboshield Gen 3 Emboshield Gen3 success were counted per filter.
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.	95.5 Event-free percentage Interval 1.72 to 6.03	—	—

SECONDARY outcome

Timeframe: Post-procedure

Population: ITT

Defined by the attainment of <50% residual stenosis covering an area no longer than the original lesion treated with the stent.

Outcome measures

Measure	Group 1 n=317 Participants Includes only the most serious event for each subject and includes only each subject's first occurrence of the event.	Emboshield Pro Gen 5 n=222 Participants Participants receiving Emboshield Pro Gen 5. Emboshield Pro success were counted per filter.	Emboshield Gen 3 n=101 Participants Participants receiving Emboshield Gen 3 Emboshield Gen3 success were counted per filter.
Acute Device Success	98.7 percentage of participants Interval 96.8 to 99.66	97.3 percentage of participants Interval 94.21 to 99.0	97.0 percentage of participants Interval 91.56 to 99.38

SECONDARY outcome

Timeframe: 30 Days

Population: ITT

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.

Outcome measures

Measure	Group 1 n=322 Participants Includes only the most serious event for each subject and includes only each subject's first occurrence of the event.	Emboshield Pro Gen 5 Participants receiving Emboshield Pro Gen 5. Emboshield Pro success were counted per filter.	Emboshield Gen 3 Participants receiving Emboshield Gen 3 Emboshield Gen3 success were counted per filter.
Procedural Success	95.30 percentage of participants Interval 92.43 to 97.37	—	—

SECONDARY outcome

Timeframe: ≤30 days

Population: ITT

Includes only each subject's first occurrence of each event.

Outcome measures

Measure	Group 1 n=322 Participants Includes only the most serious event for each subject and includes only each subject's first occurrence of the event.	Emboshield Pro Gen 5 Participants receiving Emboshield Pro Gen 5. Emboshield Pro success were counted per filter.	Emboshield Gen 3 Participants receiving Emboshield Gen 3 Emboshield Gen3 success were counted per filter.
Composite of Any Transient Ischemic Attack (TIA) and Amaurosis Fugax	2.8 percentage of participants Interval 1.29 to 5.24	—	—

SECONDARY outcome

Timeframe: 3 years

Population: ITT

Outcome measures

Measure	Group 1 n=317 Participants Includes only the most serious event for each subject and includes only each subject's first occurrence of the event.	Emboshield Pro Gen 5 Participants receiving Emboshield Pro Gen 5. Emboshield Pro success were counted per filter.	Emboshield Gen 3 Participants receiving Emboshield Gen 3 Emboshield Gen3 success were counted per filter.
Kapan-Meier Estimate of Freedom From Clinically Driven Target Lesion Revascularization Through Three Years.	98.2 Event-free percentage	—	—

Adverse Events

Group 1

Serious events: 221 serious events

Other events: 236 other events

Deaths: 0 deaths

Serious adverse events

Measure	Group 1 n=313 participants at risk
Surgical and medical procedures Epistaxis	1.6% 5/313 • Number of events 5 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Gastrointestinal disorders Gastrointestinal	10.2% 32/313 • Number of events 50 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Surgical and medical procedures Hematuria	0.96% 3/313 • Number of events 3 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Surgical and medical procedures Oropharyngeal	0.32% 1/313 • Number of events 1 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Injury, poisoning and procedural complications Other	0.96% 3/313 • Number of events 3 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Blood and lymphatic system disorders Anemia	2.6% 8/313 • Number of events 8 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Blood and lymphatic system disorders Leukopenia	0.32% 1/313 • Number of events 1 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Cardiac disorders Abnormal lab test	0.32% 1/313 • Number of events 1 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Cardiac disorders Angina	3.2% 10/313 • Number of events 15 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Cardiac disorders Arrhythmia	2.6% 8/313 • Number of events 8 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Cardiac disorders Cardiac arrest	0.32% 1/313 • Number of events 1 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Cardiac disorders Congestive heart failure	9.6% 30/313 • Number of events 41 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Cardiac disorders Coronary artery diseasee	12.5% 39/313 • Number of events 51 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Cardiac disorders Hypertensive cardiovascular disease	0.32% 1/313 • Number of events 1 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Cardiac disorders Myocardial infarctionsee	4.2% 13/313 • Number of events 13 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Cardiac disorders Structural heart disease	4.5% 14/313 • Number of events 15 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Renal and urinary disorders Hypertension	2.9% 9/313 • Number of events 9 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Cardiac disorders Hypotension	1.9% 6/313 • Number of events 6 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
General disorders Presyncope /syncope	0.96% 3/313 • Number of events 3 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
General disorders Syncope	1.9% 6/313 • Number of events 8 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Cardiac disorders Myocardial infarction Non Q wave	0.64% 2/313 • Number of events 2 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Nervous system disorders Amaurosis fugax	0.32% 1/313 • Number of events 1 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Nervous system disorders Confusion	0.64% 2/313 • Number of events 2 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Nervous system disorders Hyperperfusion syndrome	0.32% 1/313 • Number of events 1 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Nervous system disorders Neurologic other	6.7% 21/313 • Number of events 26 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Nervous system disorders Seizure	0.96% 3/313 • Number of events 4 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Skin and subcutaneous tissue disorders Subdural hematoma	0.32% 1/313 • Number of events 1 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Nervous system disorders Transient Ischemic Attack	3.5% 11/313 • Number of events 12 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Nervous system disorders Visual disturbance	0.64% 2/313 • Number of events 4 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Injury, poisoning and procedural complications Dissection	0.32% 1/313 • Number of events 2 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Injury, poisoning and procedural complications Fluid overload	0.32% 1/313 • Number of events 1 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Injury, poisoning and procedural complications Hypertension	0.32% 1/313 • Number of events 1 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Injury, poisoning and procedural complications Hypotension	8.3% 26/313 • Number of events 26 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Injury, poisoning and procedural complications Pain	0.32% 1/313 • Number of events 1 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
General disorders Urinary retention	0.32% 1/313 • Number of events 1 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Nervous system disorders Ipsilateral major	0.96% 3/313 • Number of events 3 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Nervous system disorders Ipsilateral minor	2.6% 8/313 • Number of events 8 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Vascular disorders Aneurysm	0.96% 3/313 • Number of events 3 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Vascular disorders Deep vein thrombosis	1.3% 4/313 • Number of events 4 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Injury, poisoning and procedural complications Instent restenosis	2.2% 7/313 • Number of events 9 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Vascular disorders Peripheral vascular disease	7.3% 23/313 • Number of events 30 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Vascular disorders Pseudoaneurysm	0.32% 1/313 • Number of events 1 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Vascular disorders Restenosis	0.32% 1/313 • Number of events 1 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Injury, poisoning and procedural complications Hematoma	0.64% 2/313 • Number of events 2 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Injury, poisoning and procedural complications Occlusion	0.64% 2/313 • Number of events 2 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Vascular disorders Stenosis	3.5% 11/313 • Number of events 12 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Vascular disorders Thrombosis	0.64% 2/313 • Number of events 2 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
General disorders Allergic reaction	0.32% 1/313 • Number of events 1 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer	8.3% 26/313 • Number of events 32 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Renal and urinary disorders Genitourinarynal	8.3% 26/313 • Number of events 34 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Infections and infestations Infection	8.3% 26/313 • Number of events 33 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Psychiatric disorders Mental health related	0.32% 1/313 • Number of events 1 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Metabolism and nutrition disorders Metabolic	4.5% 14/313 • Number of events 18 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
General disorders Miscellaneous	1.6% 5/313 • Number of events 5 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Musculoskeletal and connective tissue disorders Musculoskeletal	9.3% 29/313 • Number of events 33 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Respiratory, thoracic and mediastinal disorders Respiratory	17.6% 55/313 • Number of events 91 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Psychiatric disorders Trauma	1.6% 5/313 • Number of events 6 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Vascular disorders Non-ipsilateral major	1.6% 5/313 • Number of events 5 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Vascular disorders Non-ipsilateral minor	1.3% 4/313 • Number of events 5 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.

Other adverse events

Measure	Group 1 n=313 participants at risk
Blood and lymphatic system disorders Anemia	6.4% 20/313 • Number of events 23 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Cardiac disorders Arrhythmia	7.0% 22/313 • Number of events 24 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Nervous system disorders Neurologic other	11.8% 37/313 • Number of events 51 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
General disorders Headache	5.4% 17/313 • Number of events 18 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Cardiac disorders Hypotension	13.7% 43/313 • Number of events 45 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
General disorders Nausea/vomiting	5.4% 17/313 • Number of events 17 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Injury, poisoning and procedural complications Pain	9.6% 30/313 • Number of events 36 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Vascular disorders Peripheral vascular disease	8.9% 28/313 • Number of events 34 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Gastrointestinal disorders Other: Gastrointestinal	15.3% 48/313 • Number of events 98 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
General disorders Other: Genitourinary	13.7% 43/313 • Number of events 63 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Infections and infestations Other: Infection	9.9% 31/313 • Number of events 52 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
General disorders Other: Metabolic	8.9% 28/313 • Number of events 36 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
General disorders Other: Miscellaneous	20.1% 63/313 • Number of events 118 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Musculoskeletal and connective tissue disorders Other: Musculoskeletal	21.4% 67/313 • Number of events 122 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
Respiratory, thoracic and mediastinal disorders Other: Respiratory	17.6% 55/313 • Number of events 80 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.
General disorders Other: Trauma	5.1% 16/313 • Number of events 17 • Three years post-procedure Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems.

Additional Information

Ellen Travis, MS, NFP

Abbott Vascular

Phone: 408 845-1512

Email: Ellen.Travis@av.abbott.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER