Carotid Artery Disease
Conditions
Brief summary
The ROADSTER 2 Study is intended to evaluate real world usage of the ENROUTE Transcarotid Stent when used with the ENROUTE Transcarotid Neuroprotection System by physicians of varying experience with the transcarotid technique.
Interventions
None listed
Sponsors
Silk Road Medical
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient must meet one of the following criteria regarding neurological symptom status and degree of stenosis: Symptomatic: Stenosis must be \>50% as determined by an angiogram and the patient has a history of stroke (minor or non-disabling; NIHSS ≤4 or mRS ≤2), TIA and/or amaurosis fugax within 180 days of the procedure procedure ipsilateral to the carotid artery to be stented. OR Asymptomatic: Stenosis must be \>80% as determined by angiogram without any neurological symptoms within the prior 180 days. 2. Target vessel must meet all requirements for ENROUTE Transcarotid Neuroprotection System and ENROUTE Stent System (refer to IFU for requirements). 3. Patient has a discrete lesion located in the internal carotid artery (ICA) with or without involvement of the contiguous common carotid artery (CCA). 4. Patient is ≥18 years of age. 5. Patient understands the nature of the procedure and has provided a signed informed consent using a form that has been reviewed and approved by the Institutional Review Board/Ethics Committee of the respective clinical site prior to the procedure. This will be obtained prior to participation in the study. 6. Patient is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations. 7. Patient must have a life expectancy ≥ 3 years at the time of the index procedure without contingencies related to other medical, surgical or endovascular intervention. 8. Patient meets at least one of the surgical high-risk criteria listed below. Anatomic High Risk Inclusion Criteria: A. Contralateral carotid artery occlusion B. Tandem stenoses \>70% C. High cervical carotid artery stenosis D. Restenosis after carotid endarterectomy E. Bilateral carotid artery stenosis requiring treatment within 30 days after index treatment. F. Hostile Necks which the Investigator deems safe for transcarotid access including but not limited to: I. Prior neck irradiation II. Radical neck dissection III. Cervical spine immobility Clinical High Risk Inclusion Criteria: G. Patient is \> 75 years of age H. Patient has \> 2-vessel coronary artery disease and history of angina of any severity I. Patient has a history of angina * Canadian Cardiovascular Society (CCS) angina class 3 or 4 or * unstable angina J. Patient has congestive heart failure (CHF) - New York Heart Association (NYHA) * Functional Class III or IV K. Patient has known severe left ventricular dysfunction * LVEF \<30%. L. Patient has had a myocardial infarction \> 72 hours and \< 6 weeks prior to procedure. M. Patient has severe pulmonary disease (COPD) with either: * FEV1 \<50% predicted or * chronic oxygen therapy or * resting PO2 of \<60 mmHg (room air) N. Patient has permanent contralateral cranial nerve injury O. Patient has chronic renal insufficiency (serum creatinine \> 2.5 mg/dL). REMINDER: The following is a list of anatomical considerations that are not suitable for transfemoral CAS with distal protection that are NOT contraindications for enrollment in the ROADSTER 2 Study including but not limited to: I. TypeII, III, or Bovine arch II. Arch atheroma or calcification III. Atheroma of the great vessel origins IV. Tortuous distal ICA V. Tortuous or occluded iliofemoral segments VI. Occluded aortoiliac segments
Exclusion criteria
Each potential patient must be screened to ensure that they do not meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Procedural Success | 30 Days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing Major Adverse Event | 30 days | 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. |
| Number of Participants With Acute Device Success | 2 hours (periprocedural) | Acute device success is defined as the ability to insert the device, establish flow reversal, and remove the device |
| Number of Participants With Technical Success | 2 hours (periprocedural) | Technical success is defined as acute device success plus the ability to deliver interventional tools |
| Number of Participants in Which a Cranial Nerve Injury Occurred | 90 days (extended follow-up) | Rate of cranial nerve injury suspected to be caused by surgical procedure and adjudicated by CEC. |
Countries
Germany, Spain, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PP (Per Protocol) 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 | 632 |
| ITT (Intention to Treat) Patients who were enrolled in the pivotal phase of the study but had a major protocol deviation are included | 60 |
| Total | 692 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 2 |
| Overall Study | Patient refused further follow up | 6 | 2 |
| Overall Study | Physician Decision | 0 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Total | ITT (Intention to Treat) | PP (Per Protocol) |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 579 Participants | 51 Participants | 528 Participants |
| Age, Categorical Between 18 and 65 years | 113 Participants | 9 Participants | 104 Participants |
| Height | 170.2 cm STANDARD_DEVIATION 9.93 | 169.0 cm STANDARD_DEVIATION 11.8 | 170.3 cm STANDARD_DEVIATION 9.91 |
| High Surgical Risk Inclusion Criteria - Anatomic Risk Factors Bilateral carotid artery stenosis req. treatment No | 639 Participants | 59 Participants | 580 Participants |
| High Surgical Risk Inclusion Criteria - Anatomic Risk Factors Bilateral carotid artery stenosis req. treatment Yes | 53 Participants | 1 Participants | 52 Participants |
| High Surgical Risk Inclusion Criteria - Anatomic Risk Factors Contralateral Carotid Artery Occlusion No | 625 Participants | 57 Participants | 568 Participants |
| High Surgical Risk Inclusion Criteria - Anatomic Risk Factors Contralateral Carotid Artery Occlusion Yes | 67 Participants | 3 Participants | 64 Participants |
| High Surgical Risk Inclusion Criteria - Anatomic Risk Factors High cervical carotid artery stenosis No | 497 Participants | 42 Participants | 455 Participants |
| High Surgical Risk Inclusion Criteria - Anatomic Risk Factors High cervical carotid artery stenosis Yes | 195 Participants | 18 Participants | 177 Participants |
| High Surgical Risk Inclusion Criteria - Anatomic Risk Factors Hostile necks safe for transcarotid access No | 666 Participants | 58 Participants | 608 Participants |
| High Surgical Risk Inclusion Criteria - Anatomic Risk Factors Hostile necks safe for transcarotid access Yes | 26 Participants | 2 Participants | 24 Participants |
| High Surgical Risk Inclusion Criteria - Anatomic Risk Factors Restenosis after carotid endarterectomy No | 557 Participants | 47 Participants | 510 Participants |
| High Surgical Risk Inclusion Criteria - Anatomic Risk Factors Restenosis after carotid endarterectomy Yes | 135 Participants | 13 Participants | 122 Participants |
| High Surgical Risk Inclusion Criteria - Anatomic Risk Factors Tandem Stenoses >70% No | 679 Participants | 57 Participants | 622 Participants |
| High Surgical Risk Inclusion Criteria - Anatomic Risk Factors Tandem Stenoses >70% Yes | 13 Participants | 3 Participants | 10 Participants |
| Medical History >2 Vessel Coronary Disease | 14.2 Percentage of participants | 10.0 Percentage of participants | 14.6 Percentage of participants |
| Medical History Age ≥75 Years | 42.1 Percentage of participants | 45.0 Percentage of participants | 41.8 Percentage of participants |
| Medical History Age ≥80 Years | 21.1 Percentage of participants | 20.0 Percentage of participants | 21.2 Percentage of participants |
| Medical History Bilateral Stenosis Requiring Treatment | 7.7 Percentage of participants | 1.7 Percentage of participants | 8.2 Percentage of participants |
| Medical History Congestive Heart Failure | 1.7 Percentage of participants | 0.0 Percentage of participants | 1.9 Percentage of participants |
| Medical History Contralateral Carotid Occlusion | 9.7 Percentage of participants | 5.0 Percentage of participants | 10.1 Percentage of participants |
| Medical History Current Nicotine Use | 21.1 Percentage of participants | 13.3 Percentage of participants | 21.8 Percentage of participants |
| Medical History Diabetes | 36 Percentage of participants | 46.7 Percentage of participants | 35 Percentage of participants |
| Medical History Dyslipidemia | 86.3 Percentage of participants | 91.7 Percentage of participants | 85.8 Percentage of participants |
| Medical History High Cervical Carotid Stenosis | 28.2 Percentage of participants | 30.0 Percentage of participants | 28 Percentage of participants |
| Medical History History of Amaurosis Fugax | 8.5 Percentage of participants | 8.3 Percentage of participants | 8.5 Percentage of participants |
| Medical History History of Angina | 1.9 Percentage of participants | 0.0 Percentage of participants | 2.1 Percentage of participants |
| Medical History History of Coronary Artery Disease | 14.2 Percentage of participants | 10.0 Percentage of participants | 14.6 Percentage of participants |
| Medical History History of Peripheral Artery Disease | 25.1 Percentage of participants | 30.0 Percentage of participants | 24.7 Percentage of participants |
| Medical History History of Stroke | 16.4 Percentage of participants | 23.3 Percentage of participants | 15.7 Percentage of participants |
| Medical History History of TIA | 16.0 Percentage of participants | 15.0 Percentage of participants | 16.1 Percentage of participants |
| Medical History Hostile Neck Safe for Transcarotid Access | 3.8 Percentage of participants | 3.3 Percentage of participants | 3.8 Percentage of participants |
| Medical History Hypertension | 90.8 Percentage of participants | 95.0 Percentage of participants | 90.3 Percentage of participants |
| Medical History Male | 67.8 Percentage of participants | 68.3 Percentage of participants | 67.7 Percentage of participants |
| Medical History Recent MI | 0.7 Percentage of participants | 0.0 Percentage of participants | 0.8 Percentage of participants |
| Medical History Restenosis after CEA | 19.5 Percentage of participants | 21.7 Percentage of participants | 19.3 Percentage of participants |
| Medical History Severe Pulmonary Disease | 2.7 Percentage of participants | 1.7 Percentage of participants | 2.8 Percentage of participants |
| Medical History Symptomatic | 26 Percentage of participants | 23.3 Percentage of participants | 26.3 Percentage of participants |
| Race/Ethnicity, Customized African American | 35 Participants | 7 Participants | 28 Participants |
| Race/Ethnicity, Customized Asian | 7 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized Caucasian | 605 Participants | 45 Participants | 560 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 28 Participants | 5 Participants | 23 Participants |
| Race/Ethnicity, Customized Mixed Race | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Pacific Islander | 3 Participants | 0 Participants | 3 Participants |
| Race/Ethnicity, Customized Unknown/Other | 12 Participants | 1 Participants | 11 Participants |
| Sex: Female, Male Female | 223 Participants | 19 Participants | 204 Participants |
| Sex: Female, Male Male | 469 Participants | 41 Participants | 428 Participants |
| Symptomatic Status Asymptomatic | 512 Participants | 46 Participants | 466 Participants |
| Symptomatic Status Symptomatic | 180 Participants | 14 Participants | 166 Participants |
| Weight | 81.7 kg STANDARD_DEVIATION 18.48 | 83.6 kg STANDARD_DEVIATION 18.72 | 81.5 kg STANDARD_DEVIATION 18.23 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 632 | 3 / 692 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 27 / 632 | 14 / 692 |
Outcome results
Primary
Number of Participants With Procedural Success
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PP (Per Protocol) | Number of Participants With Procedural Success | 630 Participants |
| ITT (Intention to Treat) | Number of Participants With Procedural Success | 690 Participants |
Secondary
Number of Participants Experiencing Major Adverse Event
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
Population: 30 day Major Adverse Events as adjudicated by CEC
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PP (Per Protocol) | Number of Participants Experiencing Major Adverse Event | Myocardial Infarction | 6 Major Adverse Events |
| PP (Per Protocol) | Number of Participants Experiencing Major Adverse Event | Death | 1 Major Adverse Events |
| PP (Per Protocol) | Number of Participants Experiencing Major Adverse Event | Stroke | 4 Major Adverse Events |
| ITT (Intention to Treat) | Number of Participants Experiencing Major Adverse Event | Myocardial Infarction | 6 Major Adverse Events |
| ITT (Intention to Treat) | Number of Participants Experiencing Major Adverse Event | Death | 3 Major Adverse Events |
| ITT (Intention to Treat) | Number of Participants Experiencing Major Adverse Event | Stroke | 13 Major Adverse Events |
Secondary
Number of Participants in Which a Cranial Nerve Injury Occurred
Rate of cranial nerve injury suspected to be caused by surgical procedure and adjudicated by CEC.
Time frame: 90 days (extended follow-up)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PP (Per Protocol) | Number of Participants in Which a Cranial Nerve Injury Occurred | 8 Participants |
| ITT (Intention to Treat) | Number of Participants in Which a Cranial Nerve Injury Occurred | 10 Participants |
Secondary
Number of Participants With Acute Device Success
Acute device success is defined as the ability to insert the device, establish flow reversal, and remove the device
Time frame: 2 hours (periprocedural)
Population: 2 enrolled patients were withdrawn by the Investigator
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PP (Per Protocol) | Number of Participants With Acute Device Success | 630 Participants |
| ITT (Intention to Treat) | Number of Participants With Acute Device Success | 690 Participants |
Secondary
Number of Participants With Technical Success
Technical success is defined as acute device success plus the ability to deliver interventional tools
Time frame: 2 hours (periprocedural)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PP (Per Protocol) | Number of Participants With Technical Success | 630 Participants |
| ITT (Intention to Treat) | Number of Participants With Technical Success | 690 Participants |