Feasibility Study of the Treatment of Acute Ischemic Stroke Using the NOVIS Transcarotid Neuroprotection System

NCT04881162 | Terminated Results DMC FDA Device

• 1 other identifier: SRM-2019-01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Study Objective is to establish the feasibility and safety of the NOVIS Transcarotid Neuroprotection System when used for the transcarotid intervention of patients that have a failed transfemoral endovascular therapy in the case of anterior circulation strokes due to large vessel embolic occlusions.

Conditions

Acute Ischemic Stroke

Keywords

mechanical thrombectomy; stroke treatment; embolic protection; transcarotid

Outcome Measures

Primary Outcomes (3)

• Number of Device-related Serious Adverse Events

  The primary outcome measure assesses the number of vascular complications which include which include dissection, pseudoaneurysm, hematoma, arteriovenous fistula, thrombus formation, embolization and any vascular complication that may be attributed to the device AND requires surgical repair, surgical wound revision, transfusion, etc. The endpoint is measured at 90 days post-procedure.

  90 Days

• Number of Other Serious Adverse Events

  The primary outcome measure assesses the number of permanent cranial nerve injury, new symptomatic ipsilateral hemorrhage and dissections related to ancillary devices. The endpoint is measured at 90 days post-procedure.

  90 Days

• Number of Subjects With Functional Independence

  Functional independence will be evaluated by assessing the modified Rankin scale (mRS). The mRS comprises six levels from 0 to 5 of increasing severe disability with an additional level 6 indicating death. A lower score indicates a better outcome and a higher score indicates a worse outcome. A mRS score reported between 0 to 2 will be considered functionally independent and 3 to 6 to not be functionally independent or dead at point of measurement. The endpoint is measured at 90 days post-procedure.

  90 Days

Secondary Outcomes (6)

• Carotid Access Time

  Hospital arrival to neck incision, neck incision to carotid exposure, neck incision to carotid exposure, neck incision to carotid artery catheterization, neck incision to femoral venous sheath access which, and neck incision to initiation of reverse flow.

• Time to Final Revascularization

  Hospital arrival to OR, LKW to final revascularization, admission to final revascularization, OR to final revascularization, cutdown to final revascularization, arterial introduction of interventional tools to final revascularization, total reverse flow.

• Number of Device-Related Complications

  90 Days

• Neurologic Assessment

  90 Days

• Technical Sucess Rate

  Start to end of index procedure

Study Arms (1)

NOVIS Transcarotid Neuroprotection System (NPS)

EXPERIMENTAL

Patients that have failed transfemoral endovascular therapy in the case of anterior circulation strokes due to large vessel embolic occlusions will enrolled in the study and treated using the NOVIS Transcarotid NPS.

Device: NOVIS Transcarotid Neuroprotection System (NPS)

Interventions

NOVIS Transcarotid Neuroprotection System (NPS) DEVICE

The NOVIS Transcarotid Neuroprotection System (NPS) is intended to provide transcarotid vascular access and embolic protection

NOVIS Transcarotid Neuroprotection System (NPS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients presenting with acute ischemic stroke of the anterior circulation with large vessel occlusions who are eligible for revascularization using endovascular therapies (stentrievers and/or aspiration devices)
• \. Occlusion of the intracranial ICA, MCA M1, proximal MCA M2, single-vessel MCA M2, dominant MCA M2, or co-dominant MCA M2 segments
• \. Patient has failed transfemoral therapy (see Appendix 4 for definition), and at least 15 minutes have elapsed from groin puncture

You may not qualify if:

• \. Significant disease of the ipsilateral common carotid artery on routine CTA
• \. Presence of a cervical ICA loop or other high-risk anatomical features of the ICA on routine CTA, that may preclude the use of the NOVIS NPS
• \. Any active or recent hemorrhage within the past 30 days
• \. Embolectomy contraindications
• a. Pre-stroke mRS ≥2 b. NIHSS ≤ 5 c. ASPECTS ≤ 5
• \. IV tPA has been or is being administered
• \. Last known well \> 24 hours ago

Sponsors & Collaborators

• Silk Road Medical: lead

Study Sites (1)

Yale University

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

Sponsor decided to terminate study early solely due to slow enrollment leading to small number of subjects analyzed.

Results Point of Contact

• Title: Heather Smith
• Organization: Silk Road Medical

hsmith@silkroadmed.com

763-335-5160

Study Officials

• Charles Matouk, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients with acute ischemic anterior circulation stroke due to large vessel embolic occlusion who are candidates for endovascular therapy and in whom transfemoral therapy failed.

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: May 11, 2021
• Study Start: November 2, 2021
• Primary Completion: December 11, 2023
• Study Completion: December 11, 2023
• Last Updated: January 17, 2025
• Results First Posted: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)