Trial Outcomes & Findings for The ENROUTE Transcarotid Neuroprotection System (ENROUTE Transcarotid NPS) DW-MRI Evaluation (NCT NCT03982420)
NCT ID: NCT03982420
Last Updated: 2026-01-14
Results Overview
Number of Participants with new white lesions from baseline (pre-procedure) by Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI) between 12-60 hours after procedure end time up to 30 days post-procedure.
COMPLETED
55 participants
Between 12-60 hours after procedure end time to 30 days post-procedure.
2026-01-14
Participant Flow
Patients were considered enrolled after signing the informed consent and having undergone a successful Transcarotid artery revascularization (TCAR) procedure (e.g., the procedure was not aborted due to technical issues or due to local complications that precluded stent implantation). Patients who were screened but did not meet all study criteria were considered screen failures and were not enrolled.
Participant milestones
| Measure |
Single-arm
Patients requiring carotid revascularization who were treated with the FDA-cleared ENROUTE Transcarotid NPS in conjunction with the FDA-approved ENROUTE Transcarotid Stent System.
|
|---|---|
|
Overall Study
STARTED
|
55
|
|
Overall Study
COMPLETED
|
54
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The ENROUTE Transcarotid Neuroprotection System (ENROUTE Transcarotid NPS) DW-MRI Evaluation
Baseline characteristics by cohort
| Measure |
Single-arm
n=55 Participants
Patients requiring carotid revascularization who were treated with the FDA-cleared ENROUTE Transcarotid NPS in conjunction with the FDA-approved ENROUTE Transcarotid Stent System.
|
|---|---|
|
Age, Customized
≤64 Years Old
|
6 Participants
n=9 Participants
|
|
Age, Customized
65-69 Years old
|
9 Participants
n=9 Participants
|
|
Age, Customized
70-74 Years old
|
19 Participants
n=9 Participants
|
|
Age, Customized
75-79 Years old
|
11 Participants
n=9 Participants
|
|
Age, Customized
≥80 Years old
|
10 Participants
n=9 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
35 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
15 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=9 Participants
|
|
Height (cm)
|
169.5 CM
STANDARD_DEVIATION 9.63 • n=9 Participants
|
|
Weight (kg)
|
81.9 kg
STANDARD_DEVIATION 13.48 • n=9 Participants
|
|
High Risk Factors
Contralateral carotid artery occlusion · Yes
|
7 Participants
n=9 Participants
|
|
High Risk Factors
Contralateral carotid artery occlusion · No
|
48 Participants
n=9 Participants
|
|
High Risk Factors
Tandem stenoses >70% · Yes
|
2 Participants
n=9 Participants
|
|
High Risk Factors
Tandem stenoses >70% · No
|
53 Participants
n=9 Participants
|
|
High Risk Factors
High cervical carotid artery stenosis · Yes
|
23 Participants
n=9 Participants
|
|
High Risk Factors
High cervical carotid artery stenosis · No
|
32 Participants
n=9 Participants
|
|
High Risk Factors
Restenosis after carotid endarterectomy · Yes
|
11 Participants
n=9 Participants
|
|
High Risk Factors
Restenosis after carotid endarterectomy · No
|
44 Participants
n=9 Participants
|
|
High Risk Factors
Bilateral carotid artery stenosis requiring treatment · Yes
|
0 Participants
n=9 Participants
|
|
High Risk Factors
Bilateral carotid artery stenosis requiring treatment · No
|
55 Participants
n=9 Participants
|
|
High Risk Factors
Hostile Necks safe for transcarotid access · Yes
|
1 Participants
n=9 Participants
|
|
High Risk Factors
Hostile Necks safe for transcarotid access · No
|
54 Participants
n=9 Participants
|
|
High Risk Factors
Hostile Necks safe for transcarotid access Radical neck dissection · Yes
|
2 Participants
n=9 Participants
|
|
High Risk Factors
Hostile Necks safe for transcarotid access Radical neck dissection · No
|
53 Participants
n=9 Participants
|
|
High Risk Factors
Hostile Necks safe for transcarotid access Cervical spine immobility · Yes
|
5 Participants
n=9 Participants
|
|
High Risk Factors
Hostile Necks safe for transcarotid access Cervical spine immobility · No
|
50 Participants
n=9 Participants
|
|
High Risk Factors
≥75 years of age · Yes
|
21 Participants
n=9 Participants
|
|
High Risk Factors
≥75 years of age · No
|
34 Participants
n=9 Participants
|
|
High Risk Factors
≥2-vessel coronary artery disease and history of angina · Yes
|
8 Participants
n=9 Participants
|
|
High Risk Factors
≥2-vessel coronary artery disease and history of angina · No
|
47 Participants
n=9 Participants
|
|
High Risk Factors
History of angina, unstable or CCS of 3 or 4 · Yes
|
2 Participants
n=9 Participants
|
|
High Risk Factors
History of angina, unstable or CCS of 3 or 4 · No
|
53 Participants
n=9 Participants
|
|
High Risk Factors
Congestive heart failure (CHF), NYHA Functional Class III or IV · Yes
|
2 Participants
n=9 Participants
|
|
High Risk Factors
Congestive heart failure (CHF), NYHA Functional Class III or IV · No
|
53 Participants
n=9 Participants
|
|
High Risk Factors
Severe left ventricular dysfunction: LVEF <30% · Yes
|
0 Participants
n=9 Participants
|
|
High Risk Factors
Severe left ventricular dysfunction: LVEF <30% · No
|
55 Participants
n=9 Participants
|
|
High Risk Factors
Myocardial infarction >72 hours and <6 weeks prior to the procedure · Yes
|
0 Participants
n=9 Participants
|
|
High Risk Factors
Myocardial infarction >72 hours and <6 weeks prior to the procedure · No
|
55 Participants
n=9 Participants
|
|
High Risk Factors
Severe pulmonary disease (COPD) · Yes
|
3 Participants
n=9 Participants
|
|
High Risk Factors
Severe pulmonary disease (COPD) · No
|
52 Participants
n=9 Participants
|
|
High Risk Factors
Permanent contralateral cranial nerve injury · Yes
|
1 Participants
n=9 Participants
|
|
High Risk Factors
Permanent contralateral cranial nerve injury · No
|
54 Participants
n=9 Participants
|
|
High Risk Factors
Patient has chronic renal insufficiency · Yes
|
2 Participants
n=9 Participants
|
|
High Risk Factors
Patient has chronic renal insufficiency · No
|
53 Participants
n=9 Participants
|
|
Subjects with Multiple High-Risk Criteria. Number of High-Risk Factors
0 High-Risk Factors
|
0 Participants
n=9 Participants
|
|
Subjects with Multiple High-Risk Criteria. Number of High-Risk Factors
1 High-Risk Factors
|
30 Participants
n=9 Participants
|
|
Subjects with Multiple High-Risk Criteria. Number of High-Risk Factors
2 High-Risk Factors
|
18 Participants
n=9 Participants
|
|
Subjects with Multiple High-Risk Criteria. Number of High-Risk Factors
3 or More High-Risk Factors
|
7 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Between 12-60 hours after procedure end time to 30 days post-procedure.Number of Participants with new white lesions from baseline (pre-procedure) by Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI) between 12-60 hours after procedure end time up to 30 days post-procedure.
Outcome measures
| Measure |
Single-arm
n=55 Participants
Patients requiring carotid revascularization who were treated with the FDA-cleared ENROUTE Transcarotid NPS in conjunction with the FDA-approved ENROUTE Transcarotid Stent System.
|
|---|---|
|
Incidence of Ipsilateral New White Lesions, by Patient
|
12 Participants
|
PRIMARY outcome
Timeframe: 30-daysPopulation: 3 patients did not complete the 30-day DW-MRI.
Number of participants at 30 day post-procedure with persistent ipsilateral new white lesions post-procedure by Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI).
Outcome measures
| Measure |
Single-arm
n=52 Participants
Patients requiring carotid revascularization who were treated with the FDA-cleared ENROUTE Transcarotid NPS in conjunction with the FDA-approved ENROUTE Transcarotid Stent System.
|
|---|---|
|
Incidence of Ipsilateral Persistent Lesions, by Patient
|
3 Participants
|
SECONDARY outcome
Timeframe: 0 to 30 daysNumber of Participants who experienced Stroke or Neurological death between 12-60 hours after procedure end time up to 30 days post-procedure.
Outcome measures
| Measure |
Single-arm
n=55 Participants
Patients requiring carotid revascularization who were treated with the FDA-cleared ENROUTE Transcarotid NPS in conjunction with the FDA-approved ENROUTE Transcarotid Stent System.
|
|---|---|
|
All Stroke and Neurological Death
Neurological Death · No
|
55 Participants
|
|
All Stroke and Neurological Death
Stroke · Yes
|
0 Participants
|
|
All Stroke and Neurological Death
Stroke · No
|
55 Participants
|
|
All Stroke and Neurological Death
Neurological Death · Yes
|
0 Participants
|
SECONDARY outcome
Timeframe: 30-daysPopulation: Out of the 55 subjects who participated in this study, 3 participants had a total of 5 persistence white lesions at 30 days. The volume relates to the number of persistent white lesions (5).
Volume of Persistent new white lesions post-procedure by Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI) at 30-Days.
Outcome measures
| Measure |
Single-arm
n=5 Persistent White Lesions
Patients requiring carotid revascularization who were treated with the FDA-cleared ENROUTE Transcarotid NPS in conjunction with the FDA-approved ENROUTE Transcarotid Stent System.
|
|---|---|
|
Volume of DW-MRI White Lesions
|
0.21 Cubic Centimeter (cc)
Interval 0.02 to 0.98
|
SECONDARY outcome
Timeframe: 30-dayPopulation: Out of the 55 subjects who participated in this study, 3 participants had a total of 5 persistence white lesions located in the Middle Cerebral Artery at 30 days.
Number persistent new white lesions post-procedure by location by Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI) at 30-Days, categorized by location.
Outcome measures
| Measure |
Single-arm
n=5 Persistent White Lesions
Patients requiring carotid revascularization who were treated with the FDA-cleared ENROUTE Transcarotid NPS in conjunction with the FDA-approved ENROUTE Transcarotid Stent System.
|
|---|---|
|
Location of DW-MRI Lesions
Middle Cerebral Artery (MCA) Territory - Persistent 30-day lesion
|
5 Lesion
|
|
Location of DW-MRI Lesions
Posterior Cerebral Artery (PCA) Territory - Persistent 30-day lesion
|
0 Lesion
|
|
Location of DW-MRI Lesions
Anterior Cerebral Artery (ACA) Territory - Persistent 30-day lesion
|
0 Lesion
|
SECONDARY outcome
Timeframe: 0 to 30-dayPopulation: None of the patients enrolled in this study were enrolled in ROADSTER 2 study. Therefore, ROADSTER 2 specific endpoints were not evaluated.
No patients enrolled in this study were enrolled in ROADSTER 2 trial; therefore, ROADSTER 2 specific endpoints were not evaluated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30-daySubjects with persistent contralateral new white lesions post-procedure by Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI), at 30-Days.
Outcome measures
| Measure |
Single-arm
n=55 Participants
Patients requiring carotid revascularization who were treated with the FDA-cleared ENROUTE Transcarotid NPS in conjunction with the FDA-approved ENROUTE Transcarotid Stent System.
|
|---|---|
|
Rate of Contralateral New White Lesions by Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI), by Patient
|
0 Participants
|
Adverse Events
Single-arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI's right to publish individual results is restricted until after the multi-center publication is complete. The sponsor also reserves the right to review and approve all publications or presentations prior to submission.
- Publication restrictions are in place
Restriction type: OTHER