Feasibility Study of RapidPulseTM Aspiration System as Frontline Approach for Stroke Patients

Acute Ischemic Stroke Clinical Trial

— RapidPulseFS  

Official title:

Feasibility Study of RapidPulseTM Aspiration System as Frontline Approach for Patients With Acute Ischemic Stroke Due to Large Vessel Occlusions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05122637
• Other study ID #: DEV-0213
• Status: Completed
• Phase: N/A
• Start date: January 31, 2022
• Est. completion date: December 20, 2022

Study information

• Verified date: February 2023
• Source: RapidPulse, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 20, 2022
• Est. primary completion date: September 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemic Stroke
• Stroke

Intervention

Device:
• RapidPulseTM Aspiration System
The RapidPulseTM Aspiration System with Medtronic React 71 aspiration catheter and a commercially available pump.
• Standard of Care Aspiration Thrombectomy System
Commercially available aspiration catheter with commercially available aspiration pump

Locations

Country	Name	City	State
Brazil	General Hospital of Fortaleza	Fortaleza
Denmark	Odense University Hospital	Odense
Latvia	Pauls Stradinš Clinical University Hospital	Riga
Spain	Hospital General Universitari d'Alicante	Alicante
Turkey	Istanbul Aydin University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
RapidPulse, Inc

Countries where clinical trial is conducted

Brazil,  Denmark,  Latvia,  Spain,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First Pass Reperfusion Effect (FPE)	Defined by modified Thrombolysis In Cerebral Infarction scale (mTICI 2c-3) flow in the target vessel	Intra-procedural
Secondary	Frontline technical success	Defined by mTICI = 2b after the last pass with Study Device with no rescue therapy	Intra-procedural
Secondary	Good functional outcome measured by Modified Rankin Scale score of 0 - 2 at 90 days post index procedure	The Modified Rankin Scale (mRS) measures neurological disability or dependence for stroke patients on a scale of 0 (no symptoms) to 6 (deceased)	90 days
Secondary	Rate of Symptomatic intracranial hemorrhage (sICH) at 24 hours post-procedure		24 hours
Secondary	All cause mortality rate		90 days