Clinical trial NCT05122637: Feasibility Study of RapidPulseTM Aspiration System as Frontline Approach for Stroke Patients
Official title: Feasibility Study of RapidPulseTM Aspiration System as Frontline Approach for Patients With Acute Ischemic Stroke Due to Large Vessel Occlusions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Ischemic Stroke
Keywords: Large vessel occlusion
Mechanical thrombectomy
Neurovascular intervention
Lead sponsor: RapidPulse, Inc
Sponsor class: INDUSTRY
First posted: 2021-11-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Feasibility Study to evaluate the initial safety and performance of the RapidPulseTM Aspiration System in the treatment of patients with Acute Ischemic Stroke (AIS) due to Large Vessel Occlusion (LVO).

Detailed description: The purpose of this study is to evaluate the initial safety and performance of the RapidPulse Inc. RapidPulseTM Aspiration System as frontline approach for use in the treatment of patients with Acute Ischemic Stroke (AIS) due to Large Vessel Occlusion (LVO). This is a prospective, multi-center, open label study comparing the safety and performance of the RapidPulseTM Aspiration System with non-randomized retrospective controls who otherwise meet the same study inclusion/exclusion criteria. The study will enroll a maximum of 100 participants in the Treatment Arm and a maximum of 200 participants in the Control Arm at in up to 10 centers in Europe and/or Latin America. Subjects data will be collected through hospitalization with a 3 months post-procedure study visit.

Eligibility criteria: Key Inclusion Criteria:

* Age 18 years or older
* Clinical diagnosis of acute ischemic stroke with NIH Stroke Scale (NIHSS) score ≥ 6 with symptom onset (or last seen normal) up to 24 hours
* Large vessel occlusion in the intracranial internal carotid artery (ICA), middle cerebral artery (MCA) M1 or M2 segments, basilar or vertebral artery

Key Exclusion Criteria:

* Evidence of hemorrhage
* Significant mass effect and/or midline shift
* Vessel tortuosity too difficult to allow endovascular access per investigator judgment
* Severe or fatal co-morbidities

Primary outcomes:
measure: First Pass Reperfusion Effect (FPE)
timeFrame: Intra-procedural
Secondary outcomes:
measure: Frontline technical success
timeFrame: Intra-procedural
measure: Good functional outcome measured by Modified Rankin Scale score of 0 - 2 at 90 days post index procedure
timeFrame: 90 days
measure: Rate of Symptomatic intracranial hemorrhage (sICH) at 24 hours post-procedure
timeFrame: 24 hours
measure: All cause mortality rate
timeFrame: 90 days
Other outcomes:
Locations:
city: Fortaleza
country: Brazil
facility: General Hospital of Fortaleza
city: Odense
country: Denmark
facility: Odense University Hospital
city: Riga
country: Latvia
facility: Pauls Stradiņš Clinical University Hospital
city: Alicante
country: Spain
facility: Hospital General Universitari d'Alicante
city: Istanbul
country: Turkey
facility: Istanbul Aydin University
Study officials:
affiliation: University of Pittsburgh Medical Center Stroke Institute
name: Raul G Nogueira, MD
role: STUDY_CHAIR
References: