Clinical trial NCT04881162: Feasibility Study of the Treatment of Acute Ischemic Stroke Using the NOVIS Transcarotid Neuroprotection System
Official title: Feasibility Study of the Treatment of Acute Ischemic Stroke Using the NOVIS Transcarotid Neuroprotection System In Transcarotid Embolectomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Ischemic Stroke
Keywords: mechanical thrombectomy
stroke treatment
embolic protection
transcarotid
Lead sponsor: Silk Road Medical
Sponsor class: INDUSTRY
First posted: 2021-05-11
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: This is a prospective, multi-center, single arm feasibility study for the endovascular treatment of patients with acute ischemic anterior circulation strokes due to large vessel embolic occlusions using the transcarotid approach with flow reversal. Patients enrolled into the NITE 1 Study will have failed transfemoral therapy and will be followed immediately from post-op to 90 days.

Eligibility criteria: Inclusion Criteria Summary:

* 1. 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)

  2. Occlusion of the intracranial ICA, MCA M1, proximal MCA M2, single-vessel MCA M2, dominant MCA M2, or co-dominant MCA M2 segments

  3. Patient has failed transfemoral therapy (see Appendix 4 for definition), and at least 15 minutes have elapsed from groin puncture

Exclusion Criteria Summary:

* 1. Significant disease of the ipsilateral common carotid artery on routine CTA

  2. 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

  3. Any active or recent hemorrhage within the past 30 days

  4. Embolectomy contraindications

  a. Pre-stroke mRS ≥2 b. NIHSS ≤ 5 c. ASPECTS ≤ 5

  5. IV tPA has been or is being administered

  6. Last known well \> 24 hours ago

Primary outcomes:
measure: Number of Device-related Serious Adverse Events
timeFrame: 90 Days
measure: Number of Other Serious Adverse Events
timeFrame: 90 Days
measure: Number of Subjects With Functional Independence
timeFrame: 90 Days
Secondary outcomes:
measure: Carotid Access Time
timeFrame: 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.
measure: Time to Final Revascularization
timeFrame: 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.
measure: Number of Device-Related Complications
timeFrame: 90 Days
measure: Neurologic Assessment
timeFrame: 90 Days
measure: Technical Sucess Rate
timeFrame: Start to end of index procedure
measure: Revascularization Sucess Rate
timeFrame: Start to end of index procedure
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Charles Matouk, MD
role: PRINCIPAL_INVESTIGATOR
References: