Condition or disease | Intervention/treatment |
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Carotid Artery Diseases Carotid Atherosclerosis Carotid Stenosis Carotid Artery Plaque Carotid Disease | Procedure: Transcarotid Revascularization (TCAR) |
This is a prospective, single-arm, multi-center evaluation of patients requiring carotid revascularization who are treated with the FDA-cleared ENROUTE Transcarotid NPS in conjunction with the FDA-approved ENROUTE Transcarotid Stent System. Both the ENROUTE Transcarotid NPS and ENROUTE Transcarotid Stent System have received CE mark and are commercially available in the European Union.
Patients enrolled in this study will have been offered the TCAR intervention as part of standard of care for the treatment of carotid artery stenosis, regardless of whether or not they agree to be in the study. Therefore, the act of participation in this procedure will not be the determining factor in whether or not the patient receives the TCAR treatment. Subject participation means they agree to undergo two additional DW-MRI imaging procedures immediately after the procedure and at 30 days to determine whether there is an increase in new white lesions. Any other procedure other than the active collection of consent and data by the sponsor is standard of care for the treatment of carotid artery stenosis.
These patients will be monitored to document the incidence of post procedure DW-MRI lesions (relative to baseline).
Study Type : | Observational |
Estimated Enrollment : | 75 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Official Title: | The ENROUTE Transcarotid Neuroprotection System (ENROUTE Transcarotid NPS) DW-MRI Evaluation |
Actual Study Start Date : | June 27, 2019 |
Estimated Primary Completion Date : | July 2021 |
Estimated Study Completion Date : | August 2021 |
Tracking Information | |||||||
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First Submitted Date | June 6, 2019 | ||||||
First Posted Date | June 11, 2019 | ||||||
Last Update Posted Date | October 22, 2020 | ||||||
Actual Study Start Date | June 27, 2019 | ||||||
Estimated Primary Completion Date | July 2021 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures |
Incidence of ipsilateral new white lesions [ Time Frame: 30 days ] Incidence of ipsilateral new white lesions from baseline (pre-procedure) by DW-MRI to 30 days post procedure
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Original Primary Outcome Measures | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title | The ENROUTE Transcarotid Neuroprotection System (ENROUTE Transcarotid NPS) DW-MRI Evaluation | ||||||
Official Title | The ENROUTE Transcarotid Neuroprotection System (ENROUTE Transcarotid NPS) DW-MRI Evaluation | ||||||
Brief Summary | 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. | ||||||
Detailed Description |
This is a prospective, single-arm, multi-center evaluation of patients requiring carotid revascularization who are treated with the FDA-cleared ENROUTE Transcarotid NPS in conjunction with the FDA-approved ENROUTE Transcarotid Stent System. Both the ENROUTE Transcarotid NPS and ENROUTE Transcarotid Stent System have received CE mark and are commercially available in the European Union. Patients enrolled in this study will have been offered the TCAR intervention as part of standard of care for the treatment of carotid artery stenosis, regardless of whether or not they agree to be in the study. Therefore, the act of participation in this procedure will not be the determining factor in whether or not the patient receives the TCAR treatment. Subject participation means they agree to undergo two additional DW-MRI imaging procedures immediately after the procedure and at 30 days to determine whether there is an increase in new white lesions. Any other procedure other than the active collection of consent and data by the sponsor is standard of care for the treatment of carotid artery stenosis. These patients will be monitored to document the incidence of post procedure DW-MRI lesions (relative to baseline). |
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Study Type | Observational | ||||||
Study Design | Observational Model: Case-Only Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||||
Biospecimen | Not Provided | ||||||
Sampling Method | Non-Probability Sample | ||||||
Study Population | Patients participating in this evaluation will be comprised of male and female symptomatic or asymptomatic patients requiring carotid revascularization. | ||||||
Condition |
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Intervention | Procedure: Transcarotid Revascularization (TCAR)
Carotid revascularization treated with the FDA-cleared ENROUTE Transcarotid NPS in conjunction with the FDA-approved ENROUTE Transcarotid Stent
Other Name: Carotid Revascularization, Carotid Artery Stenting
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Study Groups/Cohorts | Not Provided | ||||||
Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status | Recruiting | ||||||
Estimated Enrollment |
75 | ||||||
Original Estimated Enrollment | Same as current | ||||||
Estimated Study Completion Date | August 2021 | ||||||
Estimated Primary Completion Date | July 2021 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts |
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Listed Location Countries | Spain, United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number | NCT03982420 | ||||||
Other Study ID Numbers | SRM-2018-01 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Silk Road Medical | ||||||
Study Sponsor | Silk Road Medical | ||||||
Collaborators | Not Provided | ||||||
Investigators | Not Provided | ||||||
PRS Account | Silk Road Medical | ||||||
Verification Date | October 2020 |