The Gore SCAFFOLD Clinical Study

• Sponsor: W.L.Gore & Associates (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01901874
• Collaborator: (none)
• Enrollment: 312
• Locations: 2
• Arm: 1
• Actual Duration (Months): 86
• Patients Per Site: 156
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief Summary

Evaluate the safety and efficacy of the GORE® Carotid Stent for the treatment of carotid artery stenosis in patients at increased risk for adverse events from carotid endarterectomy

Condition or Disease	Intervention/Treatment	Phase
Carotid Artery Disease; Carotid Artery Stenosis	Device: Carotid Artery Stenting	N/A

Detailed Description

This is a prospective, multicenter, single-arm clinical study comparing outcomes with the GORE® Carotid Stent to a performance goal derived from carotid endarterectomy outcomes in high-surgical-risk patients.

Study Design

• Study Type: Interventional
• Actual Enrollment: 312 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: GORE® Carotid Stent Clinical Study for the Treatment of Carotid Artery Stenosis in Patients at Increased Risk for Adverse Events From Carotid Endarterectomy
• Actual Study Start Date: Jul 1, 2013
• Actual Primary Completion Date: Dec 1, 2017
• Actual Study Completion Date: Sep 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Carotid Artery Stenting Carotid Artery Stenting with the GORE® Carotid Stent	Device: Carotid Artery Stenting; Carotid Artery Stenting with the GORE® Carotid Stent; Other Names: GORE® Carotid Stent

Outcome Measures

Primary Outcome Measures

1. Number of Participants Who Experienced Major Adverse Events (MAE) at One Year [365 days]

   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).

Secondary Outcome Measures

1. Number of Participants Who Achieved Stent Technical Success [Procedural]

   Stent Technical Success defined as successful implantation of a GORE® Carotid Stent

2. Number of Participants Who Achieved Embolic Protection Device (EPD) Technical Success [Procedural]

   EPD Technical Success defined as GORE® Embolic Filter delivered, placed, and retrieved without requiring assisting interventional methods.

3. Number of Participants Who Achieved Procedure Success [Procedural]

   Procedure Success defined as Stent Technical Success with < 30% residual stenosis and no in-hospital MAE.

4. Number of Participants Who Experienced MAE at 30 Days [30 days]

   Defined as any death, stroke, or myocardial infarction through 30 days post-index procedure.

5. 30-Day MAE - Death [30 days]

   Any cause death through 30 days post-index procedure

6. 30-Day MAE - Myocardial Infarction [30 days]

   Any myocardial infarction through 30 days post-index procedure

7. 30-Day MAE - Stroke [30 days]

   Any stroke through 30 days post-index procedure

8. In-Stent Restenosis [365 days]

   ≥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

9. Target Lesion Revascularization [365 days]

   Any clinically driven revascularization procedure that is performed to increase the luminal diameter inside or within 5 mm of the previously treated lesion

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Patient is at least 18 years old at informed consent

• Patient is willing and capable of complying with all study protocol requirements, including specified follow-up period and can be contacted by telephone.

• Patient is willing to provide written informed consent prior to enrollment in study.

• Patient is either:

• Symptomatic with carotid stenosis ≥50% as determined by angiography using NASCET methodology. Symptomatic is defined as amaurosis fugax ipsilateral to the carotid lesion; Transient Ischemic Attack (TIA) or non-disabling stroke within 180 days of the procedure within the hemisphere supplied by the target vessel; OR

• Asymptomatic with carotid stenosis ≥80% as determined by angiography using NASCET methodology

• Patient must be considered high risk for adverse events during carotid endarterectomy

Note: Additional inclusion criteria may apply

Exclusion Criteria:

• Patient has life expectancy of less than one year.

• Patient is experiencing (or has experienced) an evolving, acute, or recent disabling stroke.

• Patient has anticipated or potential sources of emboli (e.g. atrial fibrillation, known previously symptomatic patent foramen ovale (PFO), mechanical heart valve, or Deep Vein Thrombosis (DVT) treated within 6 months).

• Patient has had an acute myocardial infarction within 72 hours prior to the index procedure.

• Patient has a history of major, disabling ipsilateral stroke with residual deficit that may confound the neurological subject assessments.

• Patient has known severe carotid stenosis contralateral to the target lesion requiring treatment within 30 days following the index procedure.

Note: Additional exclusion criteria may apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaiser Permanente Hawaii	Honolulu	Hawaii	United States	96819
2	Lankenau Heart Institute	Wynnewood	Pennsylvania	United States	19096

Sponsors and Collaborators

• W.L.Gore & Associates

Investigators

• Principal Investigator: William Gray, MD, Lankenau Heart Institute
• Principal Investigator: Peter Schneider, MD, Kaiser Health System, Honolulu

Study Documents (Full-Text)

• Study Protocol - Oct 22, 2014
• Statistical Analysis Plan - Jun 10, 2014

More Information

Publications

None provided.

• Responsible Party: W.L.Gore & Associates
• ClinicalTrials.gov Identifier: NCT01901874
• Other Study ID Numbers: GCS 10-08
• First Posted: Jul 17, 2013
• Last Update Posted: Oct 29, 2020
• Last Verified: Oct 1, 2020

• Keywords provided by W.L.Gore & Associates: Stroke; Carotid Artery Stenting (CAS); Embolic Protection Device (EPD); Stent; Carotid Stenosis; Constriction, Pathologic; Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Angioplasty
• Additional relevant MeSH terms: Carotid Stenosis; Carotid Artery Diseases; Constriction, Pathologic

Study Results

Participant Flow

Arm/Group Title	Carotid Artery Stenting
Arm/Group Description	Carotid Artery Stenting with the GORE® Carotid Stent Carotid Artery Stenting: Carotid Artery Stenting with the GORE® Carotid Stent
Period Title: Procedure
STARTED	312
COMPLETED	312
NOT COMPLETED	0
Period Title: Procedure
STARTED	312
COMPLETED	265
NOT COMPLETED	47
Period Title: Procedure
STARTED	265
COMPLETED	264
NOT COMPLETED	1
Period Title: Procedure
STARTED	264
COMPLETED	244
NOT COMPLETED	20

Baseline Characteristics

Arm/Group Title	Carotid Artery Stenting
Arm/Group Description	Carotid Artery Stenting with the GORE® Carotid Stent Carotid Artery Stenting: Carotid Artery Stenting with the GORE® Carotid Stent
Overall Participants	265
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	73.1 (8.8)
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	74.4
Sex: Female, Male (Count of Participants)
Female	89 33.6%
Male	176 66.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	5 1.9%
Not Hispanic or Latino	258 97.4%
Unknown or Not Reported	2 0.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 0.4%
Asian	2 0.8%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	7 2.6%
White	252 95.1%
More than one race	3 1.1%
Unknown or Not Reported	0 0%
Diabetes Mellitus (Count of Participants)
Count of Participants [Participants]	107 40.4%
Hypertension (Count of Participants)
Count of Participants [Participants]	249 94%
Cigarette Smoking (Count of Participants)
Current or stopped <12 months ago	67 25.3%
Previous (stopped >12 months ago)	139 52.5%
Never	59 22.3%
Previous Carotid Disease (Count of Participants)
Count of Participants [Participants]	125 47.2%
Symptomatic (Count of Participants)
Count of Participants [Participants]	33 12.5%
History of Ischemic Stroke (Count of Participants)
Count of Participants [Participants]	48 18.1%
History of Transient Ischemic Attack (TIA) (Count of Participants)
Count of Participants [Participants]	40 15.1%
Ipsilateral Amaurosis Fugax or Transient Monocular Blindness (TMB) (Count of Participants)
Count of Participants [Participants]	9 3.4%
Endarterectomy (Count of Participants)
Count of Participants [Participants]	79 29.8%
Target Lesion Location (Count of Participants)
ICA	235 88.7%
Bifurcation	30 11.3%
Target Vessel Reference Diameter (mm) (millimeters) [Median (Full Range) ]
Median (Full Range) [millimeters]	5.5
Target Lesion Length (mm) (millimeters) [Median (Full Range) ]
Median (Full Range) [millimeters]	20
Target Lesion % Diameter Stenosis (percentage of vessel diameter) [Median (Full Range) ]
Median (Full Range) [percentage of vessel diameter]	85

Outcome Measures

1. Primary Outcome

Title	Number of Participants Who Experienced Major Adverse Events (MAE) at One Year
Description	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).
Time Frame	365 days

Outcome Measure Data

Analysis Population Description

Per protocol subjects with 1-year MAE evaluation

Arm/Group Title	Carotid Artery Stenting
Arm/Group Description	Carotid Artery Stenting with the GORE® Carotid Stent Carotid Artery Stenting: Carotid Artery Stenting with the GORE® Carotid Stent
Measure Participants	244
Count of Participants [Participants]	11 4.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Carotid Artery Stenting
	Comments	Test null hypothesis of equal or greater proportion with 1-year MAE compared to a performance goal (PG). H0: P ≥ 16.9% vs H1: P < 16.9%, where P is the true proportion of CAS subjects with 1-year MAE and 16.9% is the PG based on outcomes reported for patients treated with carotid endarterectomy (CEA). N=280 subjects provide ≥90% power to exclude PG with 95.1% confidence if P=10.2% under H1.
	Type of Statistical Test	Other
	Comments	Acceptable performance: favorably exclude PG=16.9% with 95.1% confidence. Wa = expected weight (proportion) anatomic = 35% Pa = CEA expected anatomic MAE = 11% Wc = expected weight (proportion) comorbid = 65% Pc = CEA expected comorbid MAE = 14% D = noninferiority delta = 4% PG = 0.35 x 11% + 0.65 x 14% + 4% = 16.9%
Statistical Test of Hypothesis	p-Value	<0.00001
	Comments	A priori 1-sided alpha = 0.049 (from simulation) to ensure overall type-1 error rate ≤ 0.05.
	Method	Binomial test (normal approximation)
	Comments
Method of Estimation	Estimation Parameter	Weighted binomial proportion
	Estimated Value	0.0448
	Confidence Interval	(1-Sided) 95.1%; to 0.0846
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.0241
	Estimation Comments	Weighted by expected fractions of anatomic and comorbid high risk subjects (35% and 65%, respectively). Standard error based on H0.

2. Secondary Outcome

Title	Number of Participants Who Achieved Stent Technical Success
Description	Stent Technical Success defined as successful implantation of a GORE® Carotid Stent
Time Frame	Procedural

Outcome Measure Data

Analysis Population Description

Per protocol subjects

Arm/Group Title	Carotid Artery Stenting
Arm/Group Description	Carotid Artery Stenting with the GORE® Carotid Stent Carotid Artery Stenting: Carotid Artery Stenting with the GORE® Carotid Stent
Measure Participants	265
Count of Participants [Participants]	265 100%

3. Secondary Outcome

Title	Number of Participants Who Achieved Embolic Protection Device (EPD) Technical Success
Description	EPD Technical Success defined as GORE® Embolic Filter delivered, placed, and retrieved without requiring assisting interventional methods.
Time Frame	Procedural

Outcome Measure Data

Analysis Population Description

Per protocol subjects

Arm/Group Title	Carotid Artery Stenting
Arm/Group Description	Carotid Artery Stenting with the GORE® Carotid Stent Carotid Artery Stenting: Carotid Artery Stenting with the GORE® Carotid Stent
Measure Participants	265
Count of Participants [Participants]	251 94.7%

4. Secondary Outcome

Title	Number of Participants Who Achieved Procedure Success
Description	Procedure Success defined as Stent Technical Success with < 30% residual stenosis and no in-hospital MAE.
Time Frame	Procedural

Outcome Measure Data

Analysis Population Description

Per protocol subjects

Arm/Group Title	Carotid Artery Stenting
Arm/Group Description	Carotid Artery Stenting with the GORE® Carotid Stent Carotid Artery Stenting: Carotid Artery Stenting with the GORE® Carotid Stent
Measure Participants	265
Count of Participants [Participants]	250 94.3%

5. Secondary Outcome

Title	Number of Participants Who Experienced MAE at 30 Days
Description	Defined as any death, stroke, or myocardial infarction through 30 days post-index procedure.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Per protocol subjects with 30-day MAE evaluation

Arm/Group Title	Carotid Artery Stenting
Arm/Group Description	Carotid Artery Stenting with the GORE® Carotid Stent Carotid Artery Stenting: Carotid Artery Stenting with the GORE® Carotid Stent
Measure Participants	264
Count of Participants [Participants]	8 3%

6. Secondary Outcome

Title	30-Day MAE - Death
Description	Any cause death through 30 days post-index procedure
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Per protocol subjects with 30-day MAE evaluation

Arm/Group Title	Carotid Artery Stenting
Arm/Group Description	Carotid Artery Stenting with the GORE® Carotid Stent Carotid Artery Stenting: Carotid Artery Stenting with the GORE® Carotid Stent
Measure Participants	264
Count of Participants [Participants]	1 0.4%

7. Secondary Outcome

Title	30-Day MAE - Myocardial Infarction
Description	Any myocardial infarction through 30 days post-index procedure
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Per protocol subjects with 30-day MAE evaluation

Arm/Group Title	Carotid Artery Stenting
Arm/Group Description	Carotid Artery Stenting with the GORE® Carotid Stent Carotid Artery Stenting: Carotid Artery Stenting with the GORE® Carotid Stent
Measure Participants	264
Count of Participants [Participants]	4 1.5%

8. Secondary Outcome

Title	30-Day MAE - Stroke
Description	Any stroke through 30 days post-index procedure
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Per protocol subjects with 30-day MAE evaluation

Arm/Group Title	Carotid Artery Stenting
Arm/Group Description	Carotid Artery Stenting with the GORE® Carotid Stent Carotid Artery Stenting: Carotid Artery Stenting with the GORE® Carotid Stent
Measure Participants	264
Count of Participants [Participants]	3 1.1%

9. Secondary Outcome

Title	In-Stent Restenosis
Description	≥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
Time Frame	365 days

Outcome Measure Data

Analysis Population Description

Per protocol subjects

Arm/Group Title	Carotid Artery Stenting
Arm/Group Description	Carotid Artery Stenting with the GORE® Carotid Stent Carotid Artery Stenting: Carotid Artery Stenting with the GORE® Carotid Stent
Measure Participants	265
Count of Participants [Participants]	4 1.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Carotid Artery Stenting
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Cumulative probability
	Estimated Value	0.018
	Confidence Interval	(2-Sided) 95%; 0.007 to 0.047
	Parameter Dispersion	Type: Value:
	Estimation Comments	Kaplan-Meier product-limit method (Greenwood's formula for standard error)

10. Secondary Outcome

Title	Target Lesion Revascularization
Description	Any clinically driven revascularization procedure that is performed to increase the luminal diameter inside or within 5 mm of the previously treated lesion
Time Frame	365 days

Outcome Measure Data

Analysis Population Description

Per protocol subjects

Arm/Group Title	Carotid Artery Stenting
Arm/Group Description	Carotid Artery Stenting with the GORE® Carotid Stent Carotid Artery Stenting: Carotid Artery Stenting with the GORE® Carotid Stent
Measure Participants	265
Count of Participants [Participants]	5 1.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Carotid Artery Stenting
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Cumulative probability
	Estimated Value	0.022
	Confidence Interval	(2-Sided) 95%; 0.009 to 0.052
	Parameter Dispersion	Type: Value:
	Estimation Comments	Kaplan-Meier product-limit method (Greenwood's formula for standard error)

Adverse Events

Time Frame	395 days (end of 1-year follow-up window)
Arm/Group Title	Carotid Artery Stenting
Arm/Group Description	Carotid Artery Stenting with the GORE® Carotid Stent Carotid Artery Stenting: Carotid Artery Stenting with the GORE® Carotid Stent
All Cause Mortality
	Carotid Artery Stenting
	Affected / at Risk (%)	# Events
Total	11/265 (4.2%)
Serious Adverse Events
	Carotid Artery Stenting
	Affected / at Risk (%)	# Events
Total	104/265 (39.2%)
Blood and lymphatic system disorders
Anaemia	4/265 (1.5%)	5
Disseminated intravascular coagulation	1/265 (0.4%)	1
Cardiac disorders
Acute myocardial infarction	4/265 (1.5%)	4
Angina pectoris	5/265 (1.9%)	5
Atrial fibrillation	1/265 (0.4%)	1
Atrial tachycardia	1/265 (0.4%)	1
Bradycardia	1/265 (0.4%)	1
Cardiac failure congestive	2/265 (0.8%)	2
Cardiomyopathy	1/265 (0.4%)	1
Coronary artery disease	5/265 (1.9%)	5
Left ventricular failure	1/265 (0.4%)	1
Pulseless electrical activity	2/265 (0.8%)	2
Sinus tachycardia	1/265 (0.4%)	1
Ventricular tachycardia	1/265 (0.4%)	1
Eye disorders
Diplopia	1/265 (0.4%)	1
Gastrointestinal disorders
Abdominal pain	1/265 (0.4%)	1
Gastrointestinal haemorrhage	4/265 (1.5%)	4
Haematemesis	1/265 (0.4%)	1
Intestinal obstruction	1/265 (0.4%)	1
Large intestine polyp	1/265 (0.4%)	1
Oesophageal varices haemorrhage	1/265 (0.4%)	1
Retroperitoneal haemorrhage	1/265 (0.4%)	1
Small intestinal obstruction	1/265 (0.4%)	1
General disorders
Adverse drug reaction	2/265 (0.8%)	2
Chest pain	1/265 (0.4%)	1
Gait disturbance	1/265 (0.4%)	1
Non-cardiac chest pain	2/265 (0.8%)	2
Vascular stent restenosis	10/265 (3.8%)	11
Vascular stent thrombosis	1/265 (0.4%)	1
Hepatobiliary disorders
Cholecystitis	1/265 (0.4%)	1
Hepatic cirrhosis	1/265 (0.4%)	1
Infections and infestations
Appendicitis	1/265 (0.4%)	1
Bronchitis	1/265 (0.4%)	1
Cellulitis	2/265 (0.8%)	2
Diverticulitis	1/265 (0.4%)	1
Osteomyelitis	1/265 (0.4%)	1
Pneumonia	10/265 (3.8%)	10
Sepsis	2/265 (0.8%)	2
Septic shock	1/265 (0.4%)	1
Urinary tract infection	3/265 (1.1%)	3
Injury, poisoning and procedural complications
Anaemia postoperative	1/265 (0.4%)	1
Autonomic dysreflexia	1/265 (0.4%)	1
Carotid artery restenosis	1/265 (0.4%)	1
Comminuted fracture	1/265 (0.4%)	1
Extradural haematoma	1/265 (0.4%)	1
Fall	1/265 (0.4%)	1
Joint injury	1/265 (0.4%)	2
Procedural hypotension	1/265 (0.4%)	1
Subdural haematoma	1/265 (0.4%)	1
Vascular pseudoaneurysm	1/265 (0.4%)	1
Investigations
Blood creatinine increased	1/265 (0.4%)	1
Metabolism and nutrition disorders
Metabolic acidosis	1/265 (0.4%)	1
Musculoskeletal and connective tissue disorders
Arthritis	1/265 (0.4%)	1
Chondrocalcinosis pyrophosphate	1/265 (0.4%)	1
Lumbar spinal stenosis	1/265 (0.4%)	1
Musculoskeletal chest pain	1/265 (0.4%)	1
Osteoarthritis	2/265 (0.8%)	2
Osteonecrosis	1/265 (0.4%)	1
Spinal osteoarthritis	1/265 (0.4%)	1
Synovial cyst	1/265 (0.4%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenosquamous cell lung cancer stage III	1/265 (0.4%)	1
Colon cancer	1/265 (0.4%)	1
Lung neoplasm malignant	1/265 (0.4%)	1
Pancreatic carcinoma	1/265 (0.4%)	1
Squamous cell carcinoma of lung	1/265 (0.4%)	1
Nervous system disorders
Ataxia	1/265 (0.4%)	1
Carotid artery dissection	1/265 (0.4%)	1
Carotid artery stenosis	9/265 (3.4%)	9
Carpal tunnel syndrome	1/265 (0.4%)	1
Cerebrovascular accident	6/265 (2.3%)	6
Dementia Alzheimer's type	1/265 (0.4%)	1
Dizziness	2/265 (0.8%)	2
Encephalopathy	1/265 (0.4%)	1
Generalised tonic-clonic seizure	1/265 (0.4%)	1
Haemorrhage intracranial	1/265 (0.4%)	1
Headache	1/265 (0.4%)	1
Hemiparesis	1/265 (0.4%)	2
Hypoaesthesia	1/265 (0.4%)	2
Ischaemic stroke	1/265 (0.4%)	1
Parkinson's disease	1/265 (0.4%)	1
Presyncope	1/265 (0.4%)	1
Seizure	2/265 (0.8%)	2
Transient ischaemic attack	4/265 (1.5%)	4
Product Issues
Device breakage	1/265 (0.4%)	1
Device malfunction	1/265 (0.4%)	2
Renal and urinary disorders
Acute kidney injury	1/265 (0.4%)	1
Chronic kidney disease	1/265 (0.4%)	1
Nephrolithiasis	1/265 (0.4%)	1
Renal artery stenosis	2/265 (0.8%)	2
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure	1/265 (0.4%)	1
Chronic obstructive pulmonary disease	3/265 (1.1%)	3
Dyspnoea exertional	1/265 (0.4%)	1
Haemoptysis	1/265 (0.4%)	1
Hypoxia	2/265 (0.8%)	2
Pneumonia aspiration	1/265 (0.4%)	1
Pulmonary mass	2/265 (0.8%)	2
Respiratory failure	4/265 (1.5%)	4
Vascular disorders
Aortic aneurysm	3/265 (1.1%)	3
Aortic aneurysm rupture	1/265 (0.4%)	1
Aortic stenosis	2/265 (0.8%)	2
Hypotension	9/265 (3.4%)	10
Intermittent claudication	2/265 (0.8%)	2
Orthostatic hypotension	1/265 (0.4%)	1
Subclavian artery thrombosis	1/265 (0.4%)	1
Other (Not Including Serious) Adverse Events
	Carotid Artery Stenting
	Affected / at Risk (%)	# Events
Total	110/265 (41.5%)
Blood and lymphatic system disorders
Anaemia	6/265 (2.3%)	6
Cardiac disorders
Angina pectoris	5/265 (1.9%)	5
Atrial fibrillation	3/265 (1.1%)	3
Bradycardia	9/265 (3.4%)	10
Gastrointestinal disorders
Constipation	3/265 (1.1%)	3
Dysphagia	3/265 (1.1%)	3
Nausea	5/265 (1.9%)	5
Vomiting	3/265 (1.1%)	3
General disorders
Fatigue	6/265 (2.3%)	6
Peripheral swelling	4/265 (1.5%)	4
Infections and infestations
Bronchitis	4/265 (1.5%)	4
Influenza	3/265 (1.1%)	3
Sinusitis	4/265 (1.5%)	4
Urinary tract infection	14/265 (5.3%)	16
Injury, poisoning and procedural complications
Incision site haematoma	5/265 (1.9%)	5
Incision site haemorrhage	8/265 (3%)	8
Laceration	6/265 (2.3%)	6
Musculoskeletal and connective tissue disorders
Arthralgia	5/265 (1.9%)	5
Back pain	4/265 (1.5%)	4
Pain in extremity	5/265 (1.9%)	5
Nervous system disorders
Dizziness	8/265 (3%)	8
Headache	14/265 (5.3%)	16
Hypoaesthesia	4/265 (1.5%)	4
Syncope	5/265 (1.9%)	5
Psychiatric disorders
Mental status changes	3/265 (1.1%)	3
Renal and urinary disorders
Urinary retention	6/265 (2.3%)	6
Respiratory, thoracic and mediastinal disorders
Dyspnoea	9/265 (3.4%)	9
Dyspnoea exertional	3/265 (1.1%)	4
Vascular disorders
Haematoma	5/265 (1.9%)	5
Hypertension	9/265 (3.4%)	9
Hypotension	24/265 (9.1%)	24

Limitations/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.