Trial Outcomes & Findings for The Gore SCAFFOLD Clinical Study (NCT NCT01901874)
NCT ID: NCT01901874
Last Updated: 2020-10-29
Results Overview
MAE defined as any death, stroke, or myocardial infarction through 30 days post-index procedure, or ipsilateral stroke between 31 days and 1 year (365 days).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
312 participants
Primary outcome timeframe
365 days
Results posted on
2020-10-29
Participant Flow
Participant milestones
| Measure |
Carotid Artery Stenting
Carotid Artery Stenting with the GORE® Carotid Stent
Carotid Artery Stenting: Carotid Artery Stenting with the GORE® Carotid Stent
|
|---|---|
|
Procedure
STARTED
|
312
|
|
Procedure
COMPLETED
|
312
|
|
Procedure
NOT COMPLETED
|
0
|
|
Screening Committee Retrospective Review
STARTED
|
312
|
|
Screening Committee Retrospective Review
COMPLETED
|
265
|
|
Screening Committee Retrospective Review
NOT COMPLETED
|
47
|
|
30-Day MAE Evaluation
STARTED
|
265
|
|
30-Day MAE Evaluation
COMPLETED
|
264
|
|
30-Day MAE Evaluation
NOT COMPLETED
|
1
|
|
1-Year (365-Day) MAE Evaluation
STARTED
|
264
|
|
1-Year (365-Day) MAE Evaluation
COMPLETED
|
244
|
|
1-Year (365-Day) MAE Evaluation
NOT COMPLETED
|
20
|
Reasons for withdrawal
| Measure |
Carotid Artery Stenting
Carotid Artery Stenting with the GORE® Carotid Stent
Carotid Artery Stenting: Carotid Artery Stenting with the GORE® Carotid Stent
|
|---|---|
|
Screening Committee Retrospective Review
Protocol Violation
|
47
|
|
30-Day MAE Evaluation
Insufficient Follow-up
|
1
|
|
1-Year (365-Day) MAE Evaluation
Death
|
7
|
|
1-Year (365-Day) MAE Evaluation
Lost to Follow-up
|
5
|
|
1-Year (365-Day) MAE Evaluation
Withdrawal by Subject
|
2
|
|
1-Year (365-Day) MAE Evaluation
Insufficient Follow-up
|
6
|
Baseline Characteristics
The Gore SCAFFOLD Clinical Study
Baseline characteristics by cohort
| Measure |
Carotid Artery Stenting
n=265 Participants
Carotid Artery Stenting with the GORE® Carotid Stent
Carotid Artery Stenting: Carotid Artery Stenting with the GORE® Carotid Stent
|
|---|---|
|
Age, Continuous
|
74.4 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
89 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
176 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
258 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
252 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Diabetes Mellitus
|
107 Participants
n=5 Participants
|
|
Hypertension
|
249 Participants
n=5 Participants
|
|
Cigarette Smoking
Current or stopped <12 months ago
|
67 Participants
n=5 Participants
|
|
Cigarette Smoking
Previous (stopped >12 months ago)
|
139 Participants
n=5 Participants
|
|
Cigarette Smoking
Never
|
59 Participants
n=5 Participants
|
|
Previous Carotid Disease
|
125 Participants
n=5 Participants
|
|
Symptomatic
|
33 Participants
n=5 Participants
|
|
History of Ischemic Stroke
|
48 Participants
n=5 Participants
|
|
History of Transient Ischemic Attack (TIA)
|
40 Participants
n=5 Participants
|
|
Ipsilateral Amaurosis Fugax or Transient Monocular Blindness (TMB)
|
9 Participants
n=5 Participants
|
|
Endarterectomy
|
79 Participants
n=5 Participants
|
|
Target Lesion Location
ICA
|
235 Participants
n=5 Participants
|
|
Target Lesion Location
Bifurcation
|
30 Participants
n=5 Participants
|
|
Target Vessel Reference Diameter (mm)
|
5.5 millimeters
n=5 Participants
|
|
Target Lesion Length (mm)
|
20 millimeters
n=5 Participants
|
|
Target Lesion % Diameter Stenosis
|
85 percentage of vessel diameter
n=5 Participants
|
PRIMARY outcome
Timeframe: 365 daysPopulation: Per protocol subjects with 1-year MAE evaluation
MAE defined as any death, stroke, or myocardial infarction through 30 days post-index procedure, or ipsilateral stroke between 31 days and 1 year (365 days).
Outcome measures
| Measure |
Carotid Artery Stenting
n=244 Participants
Carotid Artery Stenting with the GORE® Carotid Stent
Carotid Artery Stenting: Carotid Artery Stenting with the GORE® Carotid Stent
|
|---|---|
|
Number of Participants Who Experienced Major Adverse Events (MAE) at One Year
|
11 Participants
|
SECONDARY outcome
Timeframe: ProceduralPopulation: Per protocol subjects
Stent Technical Success defined as successful implantation of a GORE® Carotid Stent
Outcome measures
| Measure |
Carotid Artery Stenting
n=265 Participants
Carotid Artery Stenting with the GORE® Carotid Stent
Carotid Artery Stenting: Carotid Artery Stenting with the GORE® Carotid Stent
|
|---|---|
|
Number of Participants Who Achieved Stent Technical Success
|
265 Participants
|
SECONDARY outcome
Timeframe: ProceduralPopulation: Per protocol subjects
EPD Technical Success defined as GORE® Embolic Filter delivered, placed, and retrieved without requiring assisting interventional methods.
Outcome measures
| Measure |
Carotid Artery Stenting
n=265 Participants
Carotid Artery Stenting with the GORE® Carotid Stent
Carotid Artery Stenting: Carotid Artery Stenting with the GORE® Carotid Stent
|
|---|---|
|
Number of Participants Who Achieved Embolic Protection Device (EPD) Technical Success
|
251 Participants
|
SECONDARY outcome
Timeframe: ProceduralPopulation: Per protocol subjects
Procedure Success defined as Stent Technical Success with \< 30% residual stenosis and no in-hospital MAE.
Outcome measures
| Measure |
Carotid Artery Stenting
n=265 Participants
Carotid Artery Stenting with the GORE® Carotid Stent
Carotid Artery Stenting: Carotid Artery Stenting with the GORE® Carotid Stent
|
|---|---|
|
Number of Participants Who Achieved Procedure Success
|
250 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Per protocol subjects with 30-day MAE evaluation
Defined as any death, stroke, or myocardial infarction through 30 days post-index procedure.
Outcome measures
| Measure |
Carotid Artery Stenting
n=264 Participants
Carotid Artery Stenting with the GORE® Carotid Stent
Carotid Artery Stenting: Carotid Artery Stenting with the GORE® Carotid Stent
|
|---|---|
|
Number of Participants Who Experienced MAE at 30 Days
|
8 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Per protocol subjects with 30-day MAE evaluation
Any cause death through 30 days post-index procedure
Outcome measures
| Measure |
Carotid Artery Stenting
n=264 Participants
Carotid Artery Stenting with the GORE® Carotid Stent
Carotid Artery Stenting: Carotid Artery Stenting with the GORE® Carotid Stent
|
|---|---|
|
30-Day MAE - Death
|
1 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Per protocol subjects with 30-day MAE evaluation
Any myocardial infarction through 30 days post-index procedure
Outcome measures
| Measure |
Carotid Artery Stenting
n=264 Participants
Carotid Artery Stenting with the GORE® Carotid Stent
Carotid Artery Stenting: Carotid Artery Stenting with the GORE® Carotid Stent
|
|---|---|
|
30-Day MAE - Myocardial Infarction
|
4 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Per protocol subjects with 30-day MAE evaluation
Any stroke through 30 days post-index procedure
Outcome measures
| Measure |
Carotid Artery Stenting
n=264 Participants
Carotid Artery Stenting with the GORE® Carotid Stent
Carotid Artery Stenting: Carotid Artery Stenting with the GORE® Carotid Stent
|
|---|---|
|
30-Day MAE - Stroke
|
3 Participants
|
SECONDARY outcome
Timeframe: 365 daysPopulation: Per protocol subjects
≥80% diameter stenosis within the stented lesion or within 5 mm proximal or distal to the stent at follow-up evaluation by core lab angiographic analysis
Outcome measures
| Measure |
Carotid Artery Stenting
n=265 Participants
Carotid Artery Stenting with the GORE® Carotid Stent
Carotid Artery Stenting: Carotid Artery Stenting with the GORE® Carotid Stent
|
|---|---|
|
In-Stent Restenosis
|
4 Participants
|
SECONDARY outcome
Timeframe: 365 daysPopulation: Per protocol subjects
Any clinically driven revascularization procedure that is performed to increase the luminal diameter inside or within 5 mm of the previously treated lesion
Outcome measures
| Measure |
Carotid Artery Stenting
n=265 Participants
Carotid Artery Stenting with the GORE® Carotid Stent
Carotid Artery Stenting: Carotid Artery Stenting with the GORE® Carotid Stent
|
|---|---|
|
Target Lesion Revascularization
|
5 Participants
|
Adverse Events
Carotid Artery Stenting
Serious events: 104 serious events
Other events: 110 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Carotid Artery Stenting
n=265 participants at risk
Carotid Artery Stenting with the GORE® Carotid Stent
Carotid Artery Stenting: Carotid Artery Stenting with the GORE® Carotid Stent
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.5%
4/265 • Number of events 5 • 395 days (end of 1-year follow-up window)
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Cardiac disorders
Acute myocardial infarction
|
1.5%
4/265 • Number of events 4 • 395 days (end of 1-year follow-up window)
|
|
Cardiac disorders
Angina pectoris
|
1.9%
5/265 • Number of events 5 • 395 days (end of 1-year follow-up window)
|
|
Cardiac disorders
Atrial fibrillation
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Cardiac disorders
Atrial tachycardia
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Cardiac disorders
Bradycardia
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Cardiac disorders
Cardiac failure congestive
|
0.75%
2/265 • Number of events 2 • 395 days (end of 1-year follow-up window)
|
|
Cardiac disorders
Cardiomyopathy
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Cardiac disorders
Coronary artery disease
|
1.9%
5/265 • Number of events 5 • 395 days (end of 1-year follow-up window)
|
|
Cardiac disorders
Left ventricular failure
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Cardiac disorders
Pulseless electrical activity
|
0.75%
2/265 • Number of events 2 • 395 days (end of 1-year follow-up window)
|
|
Cardiac disorders
Sinus tachycardia
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Cardiac disorders
Ventricular tachycardia
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Eye disorders
Diplopia
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.5%
4/265 • Number of events 4 • 395 days (end of 1-year follow-up window)
|
|
Gastrointestinal disorders
Haematemesis
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
General disorders
Adverse drug reaction
|
0.75%
2/265 • Number of events 2 • 395 days (end of 1-year follow-up window)
|
|
General disorders
Chest pain
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
General disorders
Gait disturbance
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
General disorders
Non-cardiac chest pain
|
0.75%
2/265 • Number of events 2 • 395 days (end of 1-year follow-up window)
|
|
General disorders
Vascular stent restenosis
|
3.8%
10/265 • Number of events 11 • 395 days (end of 1-year follow-up window)
|
|
General disorders
Vascular stent thrombosis
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Hepatobiliary disorders
Cholecystitis
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Infections and infestations
Appendicitis
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Infections and infestations
Bronchitis
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Infections and infestations
Cellulitis
|
0.75%
2/265 • Number of events 2 • 395 days (end of 1-year follow-up window)
|
|
Infections and infestations
Diverticulitis
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Infections and infestations
Osteomyelitis
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Infections and infestations
Pneumonia
|
3.8%
10/265 • Number of events 10 • 395 days (end of 1-year follow-up window)
|
|
Infections and infestations
Sepsis
|
0.75%
2/265 • Number of events 2 • 395 days (end of 1-year follow-up window)
|
|
Infections and infestations
Septic shock
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Infections and infestations
Urinary tract infection
|
1.1%
3/265 • Number of events 3 • 395 days (end of 1-year follow-up window)
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Injury, poisoning and procedural complications
Autonomic dysreflexia
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Injury, poisoning and procedural complications
Carotid artery restenosis
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Injury, poisoning and procedural complications
Comminuted fracture
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Injury, poisoning and procedural complications
Extradural haematoma
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Injury, poisoning and procedural complications
Fall
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.38%
1/265 • Number of events 2 • 395 days (end of 1-year follow-up window)
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Investigations
Blood creatinine increased
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis pyrophosphate
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.75%
2/265 • Number of events 2 • 395 days (end of 1-year follow-up window)
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenosquamous cell lung cancer stage III
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Nervous system disorders
Ataxia
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Nervous system disorders
Carotid artery dissection
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Nervous system disorders
Carotid artery stenosis
|
3.4%
9/265 • Number of events 9 • 395 days (end of 1-year follow-up window)
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Nervous system disorders
Cerebrovascular accident
|
2.3%
6/265 • Number of events 6 • 395 days (end of 1-year follow-up window)
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Nervous system disorders
Dizziness
|
0.75%
2/265 • Number of events 2 • 395 days (end of 1-year follow-up window)
|
|
Nervous system disorders
Encephalopathy
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Nervous system disorders
Headache
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Nervous system disorders
Hemiparesis
|
0.38%
1/265 • Number of events 2 • 395 days (end of 1-year follow-up window)
|
|
Nervous system disorders
Hypoaesthesia
|
0.38%
1/265 • Number of events 2 • 395 days (end of 1-year follow-up window)
|
|
Nervous system disorders
Ischaemic stroke
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Nervous system disorders
Parkinson's disease
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Nervous system disorders
Presyncope
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Nervous system disorders
Seizure
|
0.75%
2/265 • Number of events 2 • 395 days (end of 1-year follow-up window)
|
|
Nervous system disorders
Transient ischaemic attack
|
1.5%
4/265 • Number of events 4 • 395 days (end of 1-year follow-up window)
|
|
Product Issues
Device breakage
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Product Issues
Device malfunction
|
0.38%
1/265 • Number of events 2 • 395 days (end of 1-year follow-up window)
|
|
Renal and urinary disorders
Acute kidney injury
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.75%
2/265 • Number of events 2 • 395 days (end of 1-year follow-up window)
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.1%
3/265 • Number of events 3 • 395 days (end of 1-year follow-up window)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.75%
2/265 • Number of events 2 • 395 days (end of 1-year follow-up window)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.75%
2/265 • Number of events 2 • 395 days (end of 1-year follow-up window)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.5%
4/265 • Number of events 4 • 395 days (end of 1-year follow-up window)
|
|
Vascular disorders
Aortic aneurysm
|
1.1%
3/265 • Number of events 3 • 395 days (end of 1-year follow-up window)
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Vascular disorders
Aortic stenosis
|
0.75%
2/265 • Number of events 2 • 395 days (end of 1-year follow-up window)
|
|
Vascular disorders
Hypotension
|
3.4%
9/265 • Number of events 10 • 395 days (end of 1-year follow-up window)
|
|
Vascular disorders
Intermittent claudication
|
0.75%
2/265 • Number of events 2 • 395 days (end of 1-year follow-up window)
|
|
Vascular disorders
Orthostatic hypotension
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
|
Vascular disorders
Subclavian artery thrombosis
|
0.38%
1/265 • Number of events 1 • 395 days (end of 1-year follow-up window)
|
Other adverse events
| Measure |
Carotid Artery Stenting
n=265 participants at risk
Carotid Artery Stenting with the GORE® Carotid Stent
Carotid Artery Stenting: Carotid Artery Stenting with the GORE® Carotid Stent
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.3%
6/265 • Number of events 6 • 395 days (end of 1-year follow-up window)
|
|
Cardiac disorders
Angina pectoris
|
1.9%
5/265 • Number of events 5 • 395 days (end of 1-year follow-up window)
|
|
Cardiac disorders
Atrial fibrillation
|
1.1%
3/265 • Number of events 3 • 395 days (end of 1-year follow-up window)
|
|
Cardiac disorders
Bradycardia
|
3.4%
9/265 • Number of events 10 • 395 days (end of 1-year follow-up window)
|
|
Gastrointestinal disorders
Constipation
|
1.1%
3/265 • Number of events 3 • 395 days (end of 1-year follow-up window)
|
|
Gastrointestinal disorders
Dysphagia
|
1.1%
3/265 • Number of events 3 • 395 days (end of 1-year follow-up window)
|
|
Gastrointestinal disorders
Nausea
|
1.9%
5/265 • Number of events 5 • 395 days (end of 1-year follow-up window)
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
3/265 • Number of events 3 • 395 days (end of 1-year follow-up window)
|
|
General disorders
Fatigue
|
2.3%
6/265 • Number of events 6 • 395 days (end of 1-year follow-up window)
|
|
General disorders
Peripheral swelling
|
1.5%
4/265 • Number of events 4 • 395 days (end of 1-year follow-up window)
|
|
Infections and infestations
Bronchitis
|
1.5%
4/265 • Number of events 4 • 395 days (end of 1-year follow-up window)
|
|
Infections and infestations
Influenza
|
1.1%
3/265 • Number of events 3 • 395 days (end of 1-year follow-up window)
|
|
Infections and infestations
Sinusitis
|
1.5%
4/265 • Number of events 4 • 395 days (end of 1-year follow-up window)
|
|
Infections and infestations
Urinary tract infection
|
5.3%
14/265 • Number of events 16 • 395 days (end of 1-year follow-up window)
|
|
Injury, poisoning and procedural complications
Incision site haematoma
|
1.9%
5/265 • Number of events 5 • 395 days (end of 1-year follow-up window)
|
|
Injury, poisoning and procedural complications
Incision site haemorrhage
|
3.0%
8/265 • Number of events 8 • 395 days (end of 1-year follow-up window)
|
|
Injury, poisoning and procedural complications
Laceration
|
2.3%
6/265 • Number of events 6 • 395 days (end of 1-year follow-up window)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.9%
5/265 • Number of events 5 • 395 days (end of 1-year follow-up window)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.5%
4/265 • Number of events 4 • 395 days (end of 1-year follow-up window)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.9%
5/265 • Number of events 5 • 395 days (end of 1-year follow-up window)
|
|
Nervous system disorders
Dizziness
|
3.0%
8/265 • Number of events 8 • 395 days (end of 1-year follow-up window)
|
|
Nervous system disorders
Headache
|
5.3%
14/265 • Number of events 16 • 395 days (end of 1-year follow-up window)
|
|
Nervous system disorders
Hypoaesthesia
|
1.5%
4/265 • Number of events 4 • 395 days (end of 1-year follow-up window)
|
|
Nervous system disorders
Syncope
|
1.9%
5/265 • Number of events 5 • 395 days (end of 1-year follow-up window)
|
|
Psychiatric disorders
Mental status changes
|
1.1%
3/265 • Number of events 3 • 395 days (end of 1-year follow-up window)
|
|
Renal and urinary disorders
Urinary retention
|
2.3%
6/265 • Number of events 6 • 395 days (end of 1-year follow-up window)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.4%
9/265 • Number of events 9 • 395 days (end of 1-year follow-up window)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
1.1%
3/265 • Number of events 4 • 395 days (end of 1-year follow-up window)
|
|
Vascular disorders
Haematoma
|
1.9%
5/265 • Number of events 5 • 395 days (end of 1-year follow-up window)
|
|
Vascular disorders
Hypertension
|
3.4%
9/265 • Number of events 9 • 395 days (end of 1-year follow-up window)
|
|
Vascular disorders
Hypotension
|
9.1%
24/265 • Number of events 24 • 395 days (end of 1-year follow-up window)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place