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Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER)

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ClinicalTrials.gov Identifier: NCT01685567
Recruitment Status : Completed
First Posted : September 14, 2012
Results First Posted : March 6, 2017
Last Update Posted : July 7, 2017
Sponsor:
Information provided by (Responsible Party):
Silk Road Medical

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Carotid Artery Disease
Intervention Device: MICHI NPS+f
Enrollment 219

Recruitment Details Recruitment opened November, 2012 and ended March, 2016.
Pre-assignment Details  
Arm/Group Title Intention-to-Treat (ITT)
Hide Arm/Group Description All patients who were enrolled in the pivotal phase of the study are included. Lead-in patients are not included in this group.
Period Title: Overall Study
Started 219
Completed 219
Not Completed 0
Arm/Group Title Intention-to-Treat (ITT)
Hide Arm/Group Description All patients who were enrolled in the pivotal phase of the study are included. Lead-in patients are not included in this group.
Overall Number of Baseline Participants 219
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 219 participants
72.30  (8.574)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 219 participants
Female
83
  37.9%
Male
136
  62.1%
Symptomatic Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 219 participants
Asymptomatic
175
  79.9%
Symptomatic
44
  20.1%
1.Primary Outcome
Title Hierarchical Composite of Stroke, Myocardial Infarction, and Death
Hide Description 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.
Time Frame 30-day post-procedure
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intention-to-Treat (ITT)
Hide Arm/Group Description:
All patients who were enrolled in the pivotal phase of the study are included. Lead-in patients are not included in this group.
Overall Number of Participants Analyzed 219
Measure Type: Count of Participants
Unit of Measure: Participants
8
   3.7%
2.Secondary Outcome
Title All Death (Non-hierarchical)
Hide Description The analyses to be conducted on the secondary endpoints are intended to provide additional supportive evidence of the efficacy and safety of the device.
Time Frame 0 to 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intention-to-Treat (ITT)
Hide Arm/Group Description:
All patients who were enrolled in the pivotal phase of the study are included. Lead-in patients are not included in this group.
Overall Number of Participants Analyzed 219
Measure Type: Count of Participants
Unit of Measure: Participants
2
   0.9%
3.Secondary Outcome
Title All Myocardial Infarctions (Non-hierarchical)
Hide Description The analyses to be conducted on the secondary endpoints are intended to provide additional supportive evidence of the efficacy and safety of the device.
Time Frame 0 to 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intention-to-Treat (ITT)
Hide Arm/Group Description:
All patients who were enrolled in the pivotal phase of the study are included. Lead-in patients are not included in this group.
Overall Number of Participants Analyzed 219
Measure Type: Count of Participants
Unit of Measure: Participants
4
   1.8%
4.Secondary Outcome
Title All Stroke (Non-hierarchical)
Hide Description The analyses to be conducted on the secondary endpoints are intended to provide additional supportive evidence of the efficacy and safety of the device.
Time Frame 0 to 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intention-to-Treat (ITT)
Hide Arm/Group Description:
All patients who were enrolled in the pivotal phase of the study are included. Lead-in patients are not included in this group.
Overall Number of Participants Analyzed 219
Measure Type: Count of Participants
Unit of Measure: Participants
2
   0.9%
5.Secondary Outcome
Title Ipsilateral Stroke (Non-hierarchical)
Hide Description Data on ipsilateral stroke 31-365 days post procedure will be collected to provide additional supportive evidence of the safety of the device.
Time Frame 31-365 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intention-to-Treat (ITT)
Hide Arm/Group Description:
All patients who were enrolled in the pivotal phase of the study are included. Lead-in patients are not included in this group.
Overall Number of Participants Analyzed 219
Measure Type: Count of Participants
Unit of Measure: Participants
3
   1.4%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intention-to-Treat (ITT)
Hide Arm/Group Description All patients who were enrolled in the pivotal phase of the study are included. Lead-in patients are not included in this group.
All-Cause Mortality
Intention-to-Treat (ITT)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Intention-to-Treat (ITT)
Affected / at Risk (%)
Total   29/219 (13.24%) 
Blood and lymphatic system disorders   
Anaemia  5/219 (2.28%) 
Cardiac disorders   
Myocardial Infarction  3/219 (1.37%) 
Angina Pectoris  1/219 (0.46%) 
Bradycardia  1/219 (0.46%) 
Cardiac Arrest  1/219 (0.46%) 
Cardiac Failure Acute  1/219 (0.46%) 
Gastrointestinal disorders   
Gastrointestinal Haemorrhage  1/219 (0.46%) 
General disorders   
Pyrexia  1/219 (0.46%) 
Infections and infestations   
Pneumonia  2/219 (0.91%) 
Post Procedural Cellulitis  1/219 (0.46%) 
Injury, poisoning and procedural complications   
Wound Haematoma  3/219 (1.37%) 
Incision Site Haematoma  2/219 (0.91%) 
Investigations   
Troponin Increased  1/219 (0.46%) 
Metabolism and nutrition disorders   
Diabetic Ketoacidosis  1/219 (0.46%) 
Nervous system disorders   
Cerebrovascular Accident  1/219 (0.46%) 
Ischaemic Stroke  1/219 (0.46%) 
Metabolic Encephalopathy  1/219 (0.46%) 
Psychomotor Seizures  1/219 (0.46%) 
Renal and urinary disorders   
Renal Failure  2/219 (0.91%) 
Urinary Retention  2/219 (0.91%) 
Respiratory, thoracic and mediastinal disorders   
Acute Respiratory Failure  2/219 (0.91%) 
Dyspnoea  1/219 (0.46%) 
Epistaxis  1/219 (0.46%) 
Pneumothorax  1/219 (0.46%) 
Pulmonary Embolism  1/219 (0.46%) 
Respiratory Failure  1/219 (0.46%) 
Vascular disorders   
Aortic Aneurysm  1/219 (0.46%) 
Artery Dissection  4/219 (1.83%) 
Hypotension  4/219 (1.83%) 
Hypertension  1/219 (0.46%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intention-to-Treat (ITT)
Affected / at Risk (%)
Total   118/219 (53.88%) 
Blood and lymphatic system disorders   
Anaemia  8/219 (3.65%) 
Thrombocytopenia  1/219 (0.46%) 
Cardiac disorders   
Angina Pectoris  2/219 (0.91%) 
Atrial Fibrillation  1/219 (0.46%) 
Bradycardia  5/219 (2.28%) 
Cardiac Arrest  1/219 (0.46%) 
Cardiac Failure Acute  1/219 (0.46%) 
Myocardial Infarction  4/219 (1.83%) 
Sinus Bradycardia  3/219 (1.37%) 
Tachycardia  1/219 (0.46%) 
Ventricular Extrasystoles  1/219 (0.46%) 
Ear and labyrinth disorders   
Ear Pain  1/219 (0.46%) 
Gastrointestinal disorders   
Constipation  2/219 (0.91%) 
Dysphagia  1/219 (0.46%) 
Gastrointestinal Hemorrhage  2/219 (0.91%) 
Nausea  6/219 (2.74%) 
Vomiting  3/219 (1.37%) 
General disorders   
Chest Discomfort  1/219 (0.46%) 
Device Occlusion  1/219 (0.46%) 
Oedema  1/219 (0.46%) 
Pain  25/219 (11.42%) 
Pyrexia  9/219 (4.11%) 
Vessel Puncture Site Haematoma  4/219 (1.83%) 
Immune system disorders   
Allergy To Arthropod Bite  1/219 (0.46%) 
Infections and infestations   
Acute Sinusitis  1/219 (0.46%) 
Adenoviral Upper Respiratory Infection  1/219 (0.46%) 
Bronchitis  2/219 (0.91%) 
Herpes Zoster  1/219 (0.46%) 
Infection  1/219 (0.46%) 
Pneumonia  3/219 (1.37%) 
Post Procedural Cellulitis  1/219 (0.46%) 
Rash Pustular  1/219 (0.46%) 
Upper Respiratory Tract Infection  1/219 (0.46%) 
Urinary Tract Infection  4/219 (1.83%) 
Injury, poisoning and procedural complications   
Cranial Nerve Injury  1/219 (0.46%) 
Incision Site Haematoma  4/219 (1.83%) 
Vascular Injury  1/219 (0.46%) 
Wound Haematoma  7/219 (3.20%) 
Wound Secretion  8/219 (3.65%) 
Investigations   
Blood Creatine Phosphokinase Increased  3/219 (1.37%) 
Oxygen Saturation Decreased  1/219 (0.46%) 
Troponin Increased  7/219 (3.20%) 
Metabolism and nutrition disorders   
Dehydration  1/219 (0.46%) 
Diabetic Ketoacidosis  1/219 (0.46%) 
Hyperglycaemia  1/219 (0.46%) 
Hypernatraemia  1/219 (0.46%) 
Hypokalaemia  1/219 (0.46%) 
Hypokalaemic Syndrome  1/219 (0.46%) 
Hypomagnesaemia  1/219 (0.46%) 
Hypophosphataemia  1/219 (0.46%) 
Nervous system disorders   
Carotid Artery Stenosis  1/219 (0.46%) 
Cerebrovascular Accident  1/219 (0.46%) 
Headache  4/219 (1.83%) 
Ischaemic Stroke  1/219 (0.46%) 
Metabolic Encephalopathy  1/219 (0.46%) 
Psychomotor Seizures  1/219 (0.46%) 
Psychiatric disorders   
Hallucination, Visual  1/219 (0.46%) 
Renal and urinary disorders   
Dysuria  1/219 (0.46%) 
Hematuria  4/219 (1.83%) 
Renal Failure  2/219 (0.91%) 
Urinary Retention  11/219 (5.02%) 
Respiratory, thoracic and mediastinal disorders   
Acute Respiratory Failure  2/219 (0.91%) 
Cough  2/219 (0.91%) 
Dysphonia  1/219 (0.46%) 
Dyspnoea  3/219 (1.37%) 
Epistaxis  3/219 (1.37%) 
Pneumothorax  1/219 (0.46%) 
Pulmonary Embolism  1/219 (0.46%) 
Rales  1/219 (0.46%) 
Respiratory Failure  1/219 (0.46%) 
Rhinorrhoea  1/219 (0.46%) 
Throat Irritation  3/219 (1.37%) 
Wheezing  1/219 (0.46%) 
Skin and subcutaneous tissue disorders   
Dermatitis Allergic  3/219 (1.37%) 
Ecchymosis  1/219 (0.46%) 
Skin Irritation  1/219 (0.46%) 
Surgical and medical procedures   
Therapy Regimen Changed  1/219 (0.46%) 
Vascular disorders   
Aortic Aneurysm  1/219 (0.46%) 
Artery Dissection  9/219 (4.11%) 
Hemorrhage  1/219 (0.46%) 
Hematoma  1/219 (0.46%) 
Hypertension  9/219 (4.11%) 
Hypotension  23/219 (10.50%) 
Orthostatic Hypotension  2/219 (0.91%) 
Vascular Occlusion  1/219 (0.46%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: Linda Ruedy. Sr. Director, Clinical and Regulatory Affairs
Organization: Silk Road Medical, Inc.
Phone: (408) 585-2113
Responsible Party: Silk Road Medical
ClinicalTrials.gov Identifier: NCT01685567     History of Changes
Other Study ID Numbers: SRM-2012-02
First Submitted: September 10, 2012
First Posted: September 14, 2012
Results First Submitted: December 20, 2016
Results First Posted: March 6, 2017
Last Update Posted: July 7, 2017