Trial Outcomes & Findings for Carotid Revascularization With ev3 Arterial Technology Evolution Post Approval Study (NCT NCT00530504)
NCT ID: NCT00530504
Last Updated: 2019-03-05
Results Overview
Combined incidence of Major Adverse Cardiac and Cerebrovascular Events (MACCE) defined as myocardial infarction (MI), ipsilateral cerebrovascular accident (CVA), procedure-related contralateral CVA, or death, within 30 days of implantation.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1500 participants
Primary outcome timeframe
30 Days
Results posted on
2019-03-05
Participant Flow
Participant milestones
| Measure |
Stent and Protection Device
PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device: Carotid artery stenting with distal embolic protection.
|
|---|---|
|
Overall Study
STARTED
|
1500
|
|
Overall Study
COMPLETED
|
1348
|
|
Overall Study
NOT COMPLETED
|
152
|
Reasons for withdrawal
| Measure |
Stent and Protection Device
PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device: Carotid artery stenting with distal embolic protection.
|
|---|---|
|
Overall Study
Death
|
54
|
|
Overall Study
Lost to Follow-up
|
26
|
|
Overall Study
Withdrawal by Subject
|
39
|
|
Overall Study
Exited study due to other reasons
|
33
|
Baseline Characteristics
Carotid Revascularization With ev3 Arterial Technology Evolution Post Approval Study
Baseline characteristics by cohort
| Measure |
Intervention
n=1500 Participants
PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device: Carotid artery stenting with distal embolic protection.
|
|---|---|
|
Age, Continuous
|
72.5 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
577 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
923 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 DaysCombined incidence of Major Adverse Cardiac and Cerebrovascular Events (MACCE) defined as myocardial infarction (MI), ipsilateral cerebrovascular accident (CVA), procedure-related contralateral CVA, or death, within 30 days of implantation.
Outcome measures
| Measure |
Intervention
n=1500 Participants
PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device: Carotid artery stenting with distal embolic protection.
|
|---|---|
|
Composite Rate of Death, Ipsilateral CVA, Procedure-related CVA, or Myocardial Infarction (MI) at 30 Days Post-procedure.
|
99 participants
|
Adverse Events
Intervention
Serious events: 553 serious events
Other events: 258 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intervention
n=1500 participants at risk
PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device: Carotid artery stenting with distal embolic protection.
|
|---|---|
|
Blood and lymphatic system disorders
Blood And Lymphatic System Disorders
|
2.2%
33/1500 • Number of events 34 • 30 Days
|
|
Cardiac disorders
Cardiac disorder
|
6.5%
98/1500 • Number of events 117 • 30 Days
|
|
Ear and labyrinth disorders
Ear And Labyrinth Disorders
|
0.13%
2/1500 • Number of events 2 • 30 Days
|
|
Eye disorders
Eye disorder
|
0.53%
8/1500 • Number of events 8 • 30 Days
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
2.3%
35/1500 • Number of events 42 • 30 Days
|
|
General disorders
General Disorders And Administrative Site Conditions
|
4.7%
71/1500 • Number of events 76 • 30 Days
|
|
Hepatobiliary disorders
Hepatobiliary disorders
|
0.27%
4/1500 • Number of events 5 • 30 Days
|
|
Immune system disorders
Immune System Disorders
|
0.13%
2/1500 • Number of events 2 • 30 Days
|
|
Infections and infestations
Infections And Infestations
|
3.1%
46/1500 • Number of events 51 • 30 Days
|
|
Injury, poisoning and procedural complications
Injury, Poisoning And Procedural Complications
|
1.3%
19/1500 • Number of events 20 • 30 Days
|
|
Investigations
Investigations
|
1.0%
15/1500 • Number of events 16 • 30 Days
|
|
Metabolism and nutrition disorders
Metabolism And Nutrition Disorders
|
0.67%
10/1500 • Number of events 10 • 30 Days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal And Connective Tissue Disorders
|
0.80%
12/1500 • Number of events 12 • 30 Days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms Benign, Malignant And Unspecified (Incl Cysts And Polyps)
|
0.27%
4/1500 • Number of events 4 • 30 Days
|
|
Nervous system disorders
Nervous System Disorders
|
9.5%
142/1500 • Number of events 150 • 30 Days
|
|
Psychiatric disorders
Psychiatric Disorders
|
0.73%
11/1500 • Number of events 11 • 30 Days
|
|
Renal and urinary disorders
Renal And Urinary Disorders
|
1.7%
26/1500 • Number of events 28 • 30 Days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic And Mediastinal Disorders
|
2.0%
30/1500 • Number of events 33 • 30 Days
|
|
Skin and subcutaneous tissue disorders
Skin And Subcutaneous Tissue Disorders
|
0.20%
3/1500 • Number of events 3 • 30 Days
|
|
Surgical and medical procedures
Surgical And Medical Procedures
|
1.9%
29/1500 • Number of events 29 • 30 Days
|
|
Vascular disorders
Vascular Disorders
|
17.9%
268/1500 • Number of events 284 • 30 Days
|
Other adverse events
| Measure |
Intervention
n=1500 participants at risk
PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device: Carotid artery stenting with distal embolic protection.
|
|---|---|
|
Blood and lymphatic system disorders
Blood And Lymphatic System Disorders
|
0.87%
13/1500 • Number of events 13 • 30 Days
|
|
Cardiac disorders
Cardiac disorders
|
1.6%
24/1500 • Number of events 24 • 30 Days
|
|
Ear and labyrinth disorders
Ear And Labyrinth Disorders
|
0.20%
3/1500 • Number of events 3 • 30 Days
|
|
Eye disorders
Eye Disorders
|
1.1%
17/1500 • Number of events 17 • 30 Days
|
|
Gastrointestinal disorders
Gastrointestinal Disorders
|
1.7%
25/1500 • Number of events 27 • 30 Days
|
|
General disorders
General Disorders And Administrative Site Conditions
|
2.7%
40/1500 • Number of events 41 • 30 Days
|
|
Hepatobiliary disorders
Hepatobiliary Disorders
|
0.07%
1/1500 • Number of events 1 • 30 Days
|
|
Immune system disorders
Immune System Disorders
|
0.13%
2/1500 • Number of events 2 • 30 Days
|
|
Infections and infestations
Infections And Infestations
|
2.6%
39/1500 • Number of events 47 • 30 Days
|
|
Injury, poisoning and procedural complications
Injury, Poisoning And Procedural Complications
|
0.80%
12/1500 • Number of events 12 • 30 Days
|
|
Investigations
Investigations
|
1.1%
16/1500 • Number of events 17 • 30 Days
|
|
Metabolism and nutrition disorders
Metabolism And Nutrition Disorders
|
0.47%
7/1500 • Number of events 8 • 30 Days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal And Connective Tissue Disorders
|
1.9%
29/1500 • Number of events 35 • 30 Days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms Benign, Malignant And Unspecified (Incl Cysts And Polyps)
|
0.20%
3/1500 • Number of events 3 • 30 Days
|
|
Nervous system disorders
Nervous System Disorders
|
2.9%
44/1500 • Number of events 46 • 30 Days
|
|
Psychiatric disorders
Psychiatric Disorders
|
0.47%
7/1500 • Number of events 7 • 30 Days
|
|
Renal and urinary disorders
Renal And Urinary Disorders
|
1.3%
19/1500 • Number of events 20 • 30 Days
|
|
Reproductive system and breast disorders
Reproductive System And Breast Disoders
|
0.07%
1/1500 • Number of events 1 • 30 Days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic And Mediastinal Disorders
|
1.6%
24/1500 • Number of events 27 • 30 Days
|
|
Skin and subcutaneous tissue disorders
Skin And Subcutaneous Tissue Disorders
|
0.67%
10/1500 • Number of events 11 • 30 Days
|
|
Surgical and medical procedures
Surgical And Medical Procedures
|
0.67%
10/1500 • Number of events 14 • 30 Days
|
|
Vascular disorders
Vascular Disorders
|
1.9%
29/1500 • Number of events 29 • 30 Days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee There is an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results without permission of the sponsor.
- Publication restrictions are in place
Restriction type: OTHER