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Trial record 1 of 2 for:    ROADSTER2
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POST-APPROVAL STUDY of TRANSCAROTID ARTERY REVASCULARIZATION in PATIENTS With SIGNIFICANT CAROTID ARTERY DISEASE

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ClinicalTrials.gov Identifier: NCT02536378
Recruitment Status : Completed
First Posted : August 31, 2015
Results First Posted : July 29, 2020
Last Update Posted : July 29, 2020
Sponsor:
Information provided by (Responsible Party):
Silk Road Medical

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Condition Carotid Artery Disease
Enrollment 692
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PP (Per Protocol) ITT (Intention to Treat)
Hide Arm/Group Description Patients who underwent the study procedure, independent of the success of the procedure and in the absence of major protocol deviations. The analysis of the PP population excludes those subjects for whom a major protocol deviation was identified by the CEC All patients who were enrolled in the pivotal phase of the study but had major protocol deviations
Period Title: Overall Study
Started 632 60
Completed 625 53
Not Completed 7 7
Reason Not Completed
Physician Decision             0             2
Withdrawal by Subject             0             1
Death             1             2
Patient refused further follow up             6             2
Arm/Group Title PP (Per Protocol) ITT (Intention to Treat) Total
Hide Arm/Group Description Patients who underwent the study procedure, independent of the success of the procedure and in the absence of major protocol deviations. The analysis of the PP population excludes those subjects for whom a major protocol deviation was identified by the CEC Patients who were enrolled in the pivotal phase of the study but had a major protocol deviation are included Total of all reporting groups
Overall Number of Baseline Participants 632 60 692
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 632 participants 60 participants 692 participants
<=18 years 0 0 0
Between 18 and 65 years 104 9 113
>=65 years 528 51 579
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 632 participants 60 participants 692 participants
Female 204 19 223
Male 428 41 469
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 632 participants 60 participants 692 participants
African American 28 7 35
Asian 5 2 7
Caucasian 560 45 605
Hispanic or Latino 23 5 28
Pacific Islander 3 0 3
Unknown/Other 11 1 12
Mixed Race 2 0 2
Symptomatic Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 632 participants 60 participants 692 participants
Asymptomatic 466 46 512
Symptomatic 166 14 180
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 632 participants 60 participants 692 participants
170.3  (9.91) 169.0  (11.8) 170.2  (9.93)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 632 participants 60 participants 692 participants
81.5  (18.23) 83.6  (18.72) 81.7  (18.48)
High Surgical Risk Inclusion Criteria - Anatomic Risk Factors  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 632 participants 60 participants 692 participants
Contralateral Carotid Artery Occlusion Yes
64
  10.1%
3
   5.0%
67
   9.7%
No
568
  89.9%
57
  95.0%
625
  90.3%
Tandem Stenoses >70% Yes
10
   1.6%
3
   5.0%
13
   1.9%
No
622
  98.4%
57
  95.0%
679
  98.1%
High cervical carotid artery stenosis Yes
177
  28.0%
18
  30.0%
195
  28.2%
No
455
  72.0%
42
  70.0%
497
  71.8%
Restenosis after carotid endarterectomy Yes
122
  19.3%
13
  21.7%
135
  19.5%
No
510
  80.7%
47
  78.3%
557
  80.5%
Bilateral carotid artery stenosis req. treatment Yes
52
   8.2%
1
   1.7%
53
   7.7%
No
580
  91.8%
59
  98.3%
639
  92.3%
Hostile necks safe for transcarotid access Yes
24
   3.8%
2
   3.3%
26
   3.8%
No
608
  96.2%
58
  96.7%
666
  96.2%
Medical History  
Measure Type: Number
Unit of measure:  Percentage of participants
Number Analyzed 632 participants 60 participants 692 participants
Symptomatic 26.3 23.3 26
Male 67.7 68.3 67.8
Diabetes 35 46.7 36
Hypertension 90.3 95.0 90.8
History of Peripheral Artery Disease 24.7 30.0 25.1
History of Coronary Artery Disease 14.6 10.0 14.2
History of Angina 2.1 0.0 1.9
Congestive Heart Failure 1.9 0.0 1.7
Recent MI 0.8 0.0 0.7
Severe Pulmonary Disease 2.8 1.7 2.7
Dyslipidemia 85.8 91.7 86.3
History of Stroke 15.7 23.3 16.4
History of TIA 16.1 15.0 16.0
History of Amaurosis Fugax 8.5 8.3 8.5
Current Nicotine Use 21.8 13.3 21.1
Age ≥75 Years 41.8 45.0 42.1
Age ≥80 Years 21.2 20.0 21.1
Contralateral Carotid Occlusion 10.1 5.0 9.7
High Cervical Carotid Stenosis 28 30.0 28.2
Restenosis after CEA 19.3 21.7 19.5
Bilateral Stenosis Requiring Treatment 8.2 1.7 7.7
Hostile Neck Safe for Transcarotid Access 3.8 3.3 3.8
>2 Vessel Coronary Disease 14.6 10.0 14.2
1.Primary Outcome
Title Number of Participants With Procedural Success
Hide Description Procedural success is defined as acute device success (successful insertion of the ENROUTE NPS and establishment of flow reversal), technical success (deployment of interventional tools) and the absence of a major adverse events (hierarchical stroke/death/myocardial infarction) through 30 days.
Time Frame 30 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PP (Per Protocol) ITT (Intention to Treat)
Hide Arm/Group Description:
Patients who underwent the study procedure, independent of the success of the procedure and in the absence of major protocol deviations. The analysis of the PP population excludes those subjects for whom a major protocol deviation was identified by the CEC
All patients who were enrolled in the pivotal phase of the study, including patients with major protocol deviations
Overall Number of Participants Analyzed 632 692
Measure Type: Count of Participants
Unit of Measure: Participants
630
  99.7%
690
  99.7%
2.Secondary Outcome
Title Number of Participants Experiencing Major Adverse Event
Hide Description Secondary endpoints include the 30-day rate of hierarchical stroke, death or myocardial infarction, the rate of hierarchical stroke, death or myocardial infarction by symptom status, the rate of cardiac death and the rate of neurological death.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
30 day Major Adverse Events as adjudicated by CEC
Arm/Group Title PP (Per Protocol) ITT (Intention to Treat)
Hide Arm/Group Description:
Patients who underwent the study procedure, independent of the success of the procedure and in the absence of major protocol deviations. The analysis of the PP population excludes those subjects for whom a major protocol deviation was identified by the CEC.
All patients who were enrolled in the pivotal phase of the study, including patients with major protocol deviations
Overall Number of Participants Analyzed 632 692
Measure Type: Number
Unit of Measure: Major Adverse Events
Death 1 3
Stroke 4 13
Myocardial Infarction 6 6
3.Secondary Outcome
Title Number of Participants With Acute Device Success
Hide Description Acute device success is defined as the ability to insert the device, establish flow reversal, and remove the device
Time Frame 2 hours (periprocedural)
Hide Outcome Measure Data
Hide Analysis Population Description
2 enrolled patients were withdrawn by the Investigator
Arm/Group Title PP (Per Protocol) ITT (Intention to Treat)
Hide Arm/Group Description:
Patients who underwent the study procedure, independent of the success of the procedure and in the absence of major protocol deviations. The analysis of the PP population excludes those subjects for whom a major protocol deviation was identified by the CEC
All patients who were enrolled in the pivotal phase of the study in which a major protocol deviation was identified by the CEC.
Overall Number of Participants Analyzed 632 692
Measure Type: Count of Participants
Unit of Measure: Participants
630
  99.7%
690
  99.7%
4.Secondary Outcome
Title Number of Participants With Technical Success
Hide Description Technical success is defined as acute device success plus the ability to deliver interventional tools
Time Frame 2 hours (periprocedural)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PP (Per Protocol) ITT (Intention to Treat)
Hide Arm/Group Description:
Patients who underwent the study procedure, independent of the success of the procedure and in the absence of major protocol deviations. The analysis of the PP population excludes those subjects for whom a major protocol deviation was identified by the CEC.
All patients who were enrolled in the pivotal phase of the study, including patients with major protocol deviations
Overall Number of Participants Analyzed 632 692
Measure Type: Count of Participants
Unit of Measure: Participants
630
  99.7%
690
  99.7%
5.Secondary Outcome
Title Number of Participants in Which a Cranial Nerve Injury Occurred
Hide Description Rate of cranial nerve injury suspected to be caused by surgical procedure and adjudicated by CEC.
Time Frame 90 days (extended follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PP (Per Protocol) ITT (Intention to Treat)
Hide Arm/Group Description:
Patients who underwent the study procedure, independent of the success of the procedure and in the absence of major protocol deviations. The analysis of the PP population excludes those subjects for whom a major protocol deviation was identified by the CEC.
All patients who were enrolled in the pivotal phase of the study, including patients with major protocol deviations
Overall Number of Participants Analyzed 632 692
Measure Type: Count of Participants
Unit of Measure: Participants
8
   1.3%
10
   1.4%
Time Frame Adverse events were collected throughout the life of the study: 3 years, 6 months
Adverse Event Reporting Description

Major adverse events, cranial nerve injuries, device related, and unanticipated adverse device effect event data were collected through 30 day follow-up period and recorded on the Adverse Event CRF. The Investigator or Coordinator determined whether an adverse event occurred

Major Adverse Events were defined in this study as stroke, death, or myocardial infarction as adjudicated by Clinical Events Committee.

Other Adverse Events (non-serious) were not collected or assessed for this study

 
Arm/Group Title PP (Per Protocol) ITT (Intention to Treat)
Hide Arm/Group Description Patients who underwent the study procedure, independent of the success of the procedure and in the absence of major protocol deviations. The analysis of the PP population excludes those subjects for whom a major protocol deviation was identified by the CEC All patients who were enrolled in the pivotal phase of the study in which a major protocol deviation was identified by the CEC.
All-Cause Mortality
PP (Per Protocol) ITT (Intention to Treat)
Affected / at Risk (%) Affected / at Risk (%)
Total   1/632 (0.16%)      3/692 (0.43%)    
Hide Serious Adverse Events
PP (Per Protocol) ITT (Intention to Treat)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   27/632 (4.27%)      14/692 (2.02%)    
Cardiac disorders     
Myocardial Infarction  [1]  6/632 (0.95%)  6 7/692 (1.01%)  7
General disorders     
Death - Other  [2]  1/632 (0.16%)  1 1/692 (0.14%)  1
Musculoskeletal and connective tissue disorders     
Cranial Nerve Injury  [3]  8/632 (1.27%)  8 10/692 (1.45%)  10
Nervous system disorders     
Death - Neurological  [4]  0/632 (0.00%)  0 2/692 (0.29%)  2
Stroke - Contralateral  [5]  1/632 (0.16%)  1 1/692 (0.14%)  1
Stroke - Ipsilateral  [6]  3/632 (0.47%)  3 14/692 (2.02%)  14
Surgical and medical procedures     
NPS Device Related Event  [7]  2/632 (0.32%)  2 2/692 (0.29%)  2
Possibly NPS/Stent device related event  [8]  5/632 (0.79%)  5 7/692 (1.01%)  7
Stent Device Related Event  [9]  1/632 (0.16%)  1 1/692 (0.14%)  1
Indicates events were collected by systematic assessment
[1]
Myocardial ischemia with elevation of cardiac enzymes (CK-MB or troponin) to a value 2 or more times the individual clinical center's laboratory upper limit of normal
[2]
Death that cannot be attributed to neurologic or cardiac causes
[3]
Injury to cranial nerves in the vicinity of the treated carotid artery that has not resolved by one month after the initial procedure.
[4]
Death due to stroke or other neurologic cause
[5]
A neurological deficit attributed to an acute focal injury of the central nervous system contralateral to the vessel being stented.
[6]
A neurological deficit attributed to an acute focal injury of the central nervous system ipsilateral to the vessel being stented
[7]
Includes dissection and any vascular complication that may be attributed to the procedure or devices
[8]
Includes dissection, and any vascular complication that may be attributed to the procedure or devices
[9]
Includes thrombus formation, and any vascular complication that may be attributed to the procedure or devices
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PP (Per Protocol) ITT (Intention to Treat)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/0      0/0    
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
Layout table for Results Point of Contact information
Name/Title: Ric Ruedy, Executive VP, Clinical, Regulatory and Quality Affairs
Organization: Silk Road Medical, Inc.
Phone: 408-585-2112
EMail: ric@silkroadmed.com
Layout table for additonal information
Responsible Party: Silk Road Medical
ClinicalTrials.gov Identifier: NCT02536378    
Other Study ID Numbers: SRM-2015-02
First Submitted: August 27, 2015
First Posted: August 31, 2015
Results First Submitted: June 22, 2020
Results First Posted: July 29, 2020
Last Update Posted: July 29, 2020