Last reviewed · How we verify

NCT03982420: DW-MRI-US

The ENROUTE Transcarotid Neuroprotection System (ENROUTE Transcarotid NPS) DW-MRI Evaluation

Completed Results posted Last updated 14 January 2026
What this trial tests

trial testing Transcarotid Revascularization (TCAR) in Carotid Artery Diseases in 55 participants. Completed in 19 January 2022.

Timeline
27 June 2019
Primary endpoint
19 January 2022
19 January 2022

Quick facts

Lead sponsorSilk Road Medical
StatusCompleted
Study typeOBSERVATIONAL
Enrollment55
Start date27 June 2019
Primary completion19 January 2022
Estimated completion19 January 2022
Sites6 locations across United States, Spain

Drugs / interventions tested

Conditions studied

Sponsor

Silk Road Medical

Who can join

18 and older, any sex, with Carotid Artery Diseases or Carotid Atherosclerosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Incidence of Ipsilateral New White Lesions, by Patient Primary · 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.

GroupValue95% CI
Single-arm12
Incidence of Ipsilateral Persistent Lesions, by Patient Primary · 30-days

Number of participants at 30 day post-procedure with persistent ipsilateral new white lesions post-procedure by Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI).

GroupValue95% CI
Single-arm3
All Stroke and Neurological Death Secondary · 0 to 30 days

Number of Participants who experienced Stroke or Neurological death between 12-60 hours after procedure end time up to 30 days post-procedure.

Stroke
GroupValue95% CI
Single-arm0
Single-arm55
Neurological Death
GroupValue95% CI
Single-arm0
Single-arm55
Volume of DW-MRI White Lesions Secondary · 30-days

Volume of Persistent new white lesions post-procedure by Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI) at 30-Days.

GroupValue95% CI
Single-arm0.210.02 – 0.98
Location of DW-MRI Lesions Secondary · 30-day

Number persistent new white lesions post-procedure by location by Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI) at 30-Days, categorized by location.

Middle Cerebral Artery (MCA) Territory - Persistent 30-day lesion
GroupValue95% CI
Single-arm5
Posterior Cerebral Artery (PCA) Territory - Persistent 30-day lesion
GroupValue95% CI
Single-arm0
Anterior Cerebral Artery (ACA) Territory - Persistent 30-day lesion
GroupValue95% CI
Single-arm0
Rate of Contralateral New White Lesions by Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI), by Patient Secondary · 30-day

Subjects with persistent contralateral new white lesions post-procedure by Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI), at 30-Days.

GroupValue95% CI
Single-arm0

Sponsor's own description

The goal of this evaluation is to document the incidence of post procedure DW-MRI lesions (relative to baseline) in patients treated with the transcarotid artery revascularization (TCAR) procedure.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Carotid Artery Diseases

Currently open trials in the same condition.

Other Silk Road Medical trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03982420.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing