Trial Outcomes & Findings for Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (NCT NCT01685567)
NCT ID: NCT01685567
Last Updated: 2017-07-07
Results Overview
The primary endpoint was a hierarchical composite of any stroke, myocardial infarction and death during a 30-day post-procedural period in the ITT (pivotal and extended enrollment) population comprised of subjects deemed to be high risk for complications from CEA.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
219 participants
Primary outcome timeframe
30-day post-procedure
Results posted on
2017-07-07
Participant Flow
Recruitment opened November, 2012 and ended March, 2016.
Participant milestones
| Measure |
Intention-to-Treat (ITT)
All patients who were enrolled in the pivotal phase of the study are included. Lead-in patients are not included in this group.
|
|---|---|
|
Overall Study
STARTED
|
219
|
|
Overall Study
COMPLETED
|
219
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure
Baseline characteristics by cohort
| Measure |
Intention-to-Treat (ITT)
n=219 Participants
All patients who were enrolled in the pivotal phase of the study are included. Lead-in patients are not included in this group.
|
|---|---|
|
Age, Continuous
|
72.30 years
STANDARD_DEVIATION 8.574 • n=5 Participants
|
|
Sex: Female, Male
Female
|
83 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
136 Participants
n=5 Participants
|
|
Symptomatic Status
Asymptomatic
|
175 Participants
n=5 Participants
|
|
Symptomatic Status
Symptomatic
|
44 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30-day post-procedureThe primary endpoint was a hierarchical composite of any stroke, myocardial infarction and death during a 30-day post-procedural period in the ITT (pivotal and extended enrollment) population comprised of subjects deemed to be high risk for complications from CEA.
Outcome measures
| Measure |
Intention-to-Treat (ITT)
n=219 Participants
All patients who were enrolled in the pivotal phase of the study are included. Lead-in patients are not included in this group.
|
|---|---|
|
Hierarchical Composite of Stroke, Myocardial Infarction, and Death
|
8 Participants
|
SECONDARY outcome
Timeframe: 0 to 30 daysThe analyses to be conducted on the secondary endpoints are intended to provide additional supportive evidence of the efficacy and safety of the device.
Outcome measures
| Measure |
Intention-to-Treat (ITT)
n=219 Participants
All patients who were enrolled in the pivotal phase of the study are included. Lead-in patients are not included in this group.
|
|---|---|
|
All Death (Non-hierarchical)
|
2 Participants
|
SECONDARY outcome
Timeframe: 0 to 30 daysThe analyses to be conducted on the secondary endpoints are intended to provide additional supportive evidence of the efficacy and safety of the device.
Outcome measures
| Measure |
Intention-to-Treat (ITT)
n=219 Participants
All patients who were enrolled in the pivotal phase of the study are included. Lead-in patients are not included in this group.
|
|---|---|
|
All Myocardial Infarctions (Non-hierarchical)
|
4 Participants
|
SECONDARY outcome
Timeframe: 0 to 30 daysThe analyses to be conducted on the secondary endpoints are intended to provide additional supportive evidence of the efficacy and safety of the device.
Outcome measures
| Measure |
Intention-to-Treat (ITT)
n=219 Participants
All patients who were enrolled in the pivotal phase of the study are included. Lead-in patients are not included in this group.
|
|---|---|
|
All Stroke (Non-hierarchical)
|
2 Participants
|
SECONDARY outcome
Timeframe: 31-365 daysData on ipsilateral stroke 31-365 days post procedure will be collected to provide additional supportive evidence of the safety of the device.
Outcome measures
| Measure |
Intention-to-Treat (ITT)
n=219 Participants
All patients who were enrolled in the pivotal phase of the study are included. Lead-in patients are not included in this group.
|
|---|---|
|
Ipsilateral Stroke (Non-hierarchical)
|
3 Participants
|
Adverse Events
Intention-to-Treat (ITT)
Serious events: 29 serious events
Other events: 118 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intention-to-Treat (ITT)
n=219 participants at risk
All patients who were enrolled in the pivotal phase of the study are included. Lead-in patients are not included in this group.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.3%
5/219
|
|
Cardiac disorders
Myocardial Infarction
|
1.4%
3/219
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.46%
1/219
|
|
General disorders
Pyrexia
|
0.46%
1/219
|
|
Infections and infestations
Pneumonia
|
0.91%
2/219
|
|
Injury, poisoning and procedural complications
Wound Haematoma
|
1.4%
3/219
|
|
Cardiac disorders
Angina Pectoris
|
0.46%
1/219
|
|
Cardiac disorders
Bradycardia
|
0.46%
1/219
|
|
Cardiac disorders
Cardiac Arrest
|
0.46%
1/219
|
|
Cardiac disorders
Cardiac Failure Acute
|
0.46%
1/219
|
|
Infections and infestations
Post Procedural Cellulitis
|
0.46%
1/219
|
|
Injury, poisoning and procedural complications
Incision Site Haematoma
|
0.91%
2/219
|
|
Investigations
Troponin Increased
|
0.46%
1/219
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
0.46%
1/219
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.46%
1/219
|
|
Nervous system disorders
Ischaemic Stroke
|
0.46%
1/219
|
|
Nervous system disorders
Metabolic Encephalopathy
|
0.46%
1/219
|
|
Nervous system disorders
Psychomotor Seizures
|
0.46%
1/219
|
|
Renal and urinary disorders
Renal Failure
|
0.91%
2/219
|
|
Renal and urinary disorders
Urinary Retention
|
0.91%
2/219
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.91%
2/219
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.46%
1/219
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.46%
1/219
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.46%
1/219
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.46%
1/219
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.46%
1/219
|
|
Vascular disorders
Aortic Aneurysm
|
0.46%
1/219
|
|
Vascular disorders
Artery Dissection
|
1.8%
4/219
|
|
Vascular disorders
Hypotension
|
1.8%
4/219
|
|
Vascular disorders
Hypertension
|
0.46%
1/219
|
Other adverse events
| Measure |
Intention-to-Treat (ITT)
n=219 participants at risk
All patients who were enrolled in the pivotal phase of the study are included. Lead-in patients are not included in this group.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.7%
8/219
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.46%
1/219
|
|
Cardiac disorders
Angina Pectoris
|
0.91%
2/219
|
|
Cardiac disorders
Atrial Fibrillation
|
0.46%
1/219
|
|
Cardiac disorders
Bradycardia
|
2.3%
5/219
|
|
Cardiac disorders
Cardiac Arrest
|
0.46%
1/219
|
|
Cardiac disorders
Cardiac Failure Acute
|
0.46%
1/219
|
|
Cardiac disorders
Myocardial Infarction
|
1.8%
4/219
|
|
Cardiac disorders
Sinus Bradycardia
|
1.4%
3/219
|
|
Cardiac disorders
Tachycardia
|
0.46%
1/219
|
|
Cardiac disorders
Ventricular Extrasystoles
|
0.46%
1/219
|
|
Ear and labyrinth disorders
Ear Pain
|
0.46%
1/219
|
|
Gastrointestinal disorders
Constipation
|
0.91%
2/219
|
|
Gastrointestinal disorders
Dysphagia
|
0.46%
1/219
|
|
Gastrointestinal disorders
Gastrointestinal Hemorrhage
|
0.91%
2/219
|
|
Gastrointestinal disorders
Nausea
|
2.7%
6/219
|
|
Gastrointestinal disorders
Vomiting
|
1.4%
3/219
|
|
General disorders
Chest Discomfort
|
0.46%
1/219
|
|
General disorders
Device Occlusion
|
0.46%
1/219
|
|
General disorders
Oedema
|
0.46%
1/219
|
|
General disorders
Pain
|
11.4%
25/219
|
|
General disorders
Pyrexia
|
4.1%
9/219
|
|
General disorders
Vessel Puncture Site Haematoma
|
1.8%
4/219
|
|
Immune system disorders
Allergy To Arthropod Bite
|
0.46%
1/219
|
|
Infections and infestations
Acute Sinusitis
|
0.46%
1/219
|
|
Infections and infestations
Adenoviral Upper Respiratory Infection
|
0.46%
1/219
|
|
Infections and infestations
Bronchitis
|
0.91%
2/219
|
|
Infections and infestations
Herpes Zoster
|
0.46%
1/219
|
|
Infections and infestations
Infection
|
0.46%
1/219
|
|
Infections and infestations
Pneumonia
|
1.4%
3/219
|
|
Infections and infestations
Post Procedural Cellulitis
|
0.46%
1/219
|
|
Infections and infestations
Rash Pustular
|
0.46%
1/219
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.46%
1/219
|
|
Infections and infestations
Urinary Tract Infection
|
1.8%
4/219
|
|
Injury, poisoning and procedural complications
Cranial Nerve Injury
|
0.46%
1/219
|
|
Injury, poisoning and procedural complications
Incision Site Haematoma
|
1.8%
4/219
|
|
Injury, poisoning and procedural complications
Vascular Injury
|
0.46%
1/219
|
|
Injury, poisoning and procedural complications
Wound Haematoma
|
3.2%
7/219
|
|
Injury, poisoning and procedural complications
Wound Secretion
|
3.7%
8/219
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
1.4%
3/219
|
|
Investigations
Oxygen Saturation Decreased
|
0.46%
1/219
|
|
Investigations
Troponin Increased
|
3.2%
7/219
|
|
Metabolism and nutrition disorders
Dehydration
|
0.46%
1/219
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
0.46%
1/219
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.46%
1/219
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.46%
1/219
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.46%
1/219
|
|
Metabolism and nutrition disorders
Hypokalaemic Syndrome
|
0.46%
1/219
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.46%
1/219
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.46%
1/219
|
|
Nervous system disorders
Carotid Artery Stenosis
|
0.46%
1/219
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.46%
1/219
|
|
Nervous system disorders
Headache
|
1.8%
4/219
|
|
Nervous system disorders
Ischaemic Stroke
|
0.46%
1/219
|
|
Nervous system disorders
Metabolic Encephalopathy
|
0.46%
1/219
|
|
Nervous system disorders
Psychomotor Seizures
|
0.46%
1/219
|
|
Psychiatric disorders
Hallucination, Visual
|
0.46%
1/219
|
|
Renal and urinary disorders
Dysuria
|
0.46%
1/219
|
|
Renal and urinary disorders
Hematuria
|
1.8%
4/219
|
|
Renal and urinary disorders
Renal Failure
|
0.91%
2/219
|
|
Renal and urinary disorders
Urinary Retention
|
5.0%
11/219
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.91%
2/219
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.91%
2/219
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.46%
1/219
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.4%
3/219
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.4%
3/219
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.46%
1/219
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.46%
1/219
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.46%
1/219
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.46%
1/219
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.46%
1/219
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
1.4%
3/219
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.46%
1/219
|
|
Skin and subcutaneous tissue disorders
Dermatitis Allergic
|
1.4%
3/219
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.46%
1/219
|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
0.46%
1/219
|
|
Surgical and medical procedures
Therapy Regimen Changed
|
0.46%
1/219
|
|
Vascular disorders
Aortic Aneurysm
|
0.46%
1/219
|
|
Vascular disorders
Artery Dissection
|
4.1%
9/219
|
|
Vascular disorders
Hemorrhage
|
0.46%
1/219
|
|
Vascular disorders
Hematoma
|
0.46%
1/219
|
|
Vascular disorders
Hypertension
|
4.1%
9/219
|
|
Vascular disorders
Hypotension
|
10.5%
23/219
|
|
Vascular disorders
Orthostatic Hypotension
|
0.91%
2/219
|
|
Vascular disorders
Vascular Occlusion
|
0.46%
1/219
|
Additional Information
Linda Ruedy. Sr. Director, Clinical and Regulatory Affairs
Silk Road Medical, Inc.
Phone: (408) 585-2113
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place