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.
| Group | Value | 95% CI |
|---|---|---|
| Single-arm | 12 |
Last reviewed · How we verify
The ENROUTE Transcarotid Neuroprotection System (ENROUTE Transcarotid NPS) DW-MRI Evaluation
trial testing Transcarotid Revascularization (TCAR) in Carotid Artery Diseases in 55 participants. Completed in 19 January 2022.
| Lead sponsor | Silk Road Medical |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 55 |
| Start date | 27 June 2019 |
| Primary completion | 19 January 2022 |
| Estimated completion | 19 January 2022 |
| Sites | 6 locations across United States, Spain |
Silk Road Medical
18 and older, any sex, with Carotid Artery Diseases or Carotid Atherosclerosis. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Single-arm | 12 |
Number of participants at 30 day post-procedure with persistent ipsilateral new white lesions post-procedure by Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI).
| Group | Value | 95% CI |
|---|---|---|
| Single-arm | 3 |
Number of Participants who experienced Stroke or Neurological death between 12-60 hours after procedure end time up to 30 days post-procedure.
| Group | Value | 95% CI |
|---|---|---|
| Single-arm | 0 | |
| Single-arm | 55 |
| Group | Value | 95% CI |
|---|---|---|
| Single-arm | 0 | |
| Single-arm | 55 |
Volume of Persistent new white lesions post-procedure by Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI) at 30-Days.
| Group | Value | 95% CI |
|---|---|---|
| Single-arm | 0.21 | 0.02 – 0.98 |
Number persistent new white lesions post-procedure by location by Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI) at 30-Days, categorized by location.
| Group | Value | 95% CI |
|---|---|---|
| Single-arm | 5 |
| Group | Value | 95% CI |
|---|---|---|
| Single-arm | 0 |
| Group | Value | 95% CI |
|---|---|---|
| Single-arm | 0 |
Subjects with persistent contralateral new white lesions post-procedure by Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI), at 30-Days.
| Group | Value | 95% CI |
|---|---|---|
| Single-arm | 0 |
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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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