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

NCT05577351 | Completed

• 1 other identifier: CIP-0004
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

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) in the intracranial ICA, M1, M2, basilar or vertebral arteries.

Conditions

Acute Ischemic Stroke

Keywords

Stroke; Large Vessel Occlusion; Mechanical Thrombectomy; Neurovascular Intervention

Outcome Measures

Primary Outcomes (1)

• First Pass Reperfusion Effect (FPE)

  Defined by mTICI greater than or equal to 2c after one reperfusion attempt

  Intra-procedural

Other Outcomes (4)

• Frontline Technical Success

  Intra-procedural

• Final mTICI

  Intra-procedural

• Modified First Pass Reperfusion Effect (mFPE)

  Intra-procedural

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Each subject will undergo baseline evaluation for acute ischemic stroke due to large vessel occlusion, per standard of care and undergo mechanical thrombectomy procedure, aspiration to remove thrombus in the neuro-vasculature using the RapidPulseTM (feasibility) device.

Device: RapidPulseTM Aspiration System

Interventions

RapidPulseTM Aspiration System DEVICE

The RapidPulseTM Aspiration System paired with a single-use, disposable tubing set specific for use with the RapidPulseTM Aspiration System

Also known as: Aspiration Thrombectomy

Treatment Arm

Eligibility Criteria

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

You may qualify if:

• Age 18 years or older
• Clinical diagnosis of acute ischemic stroke with symptom onset (or last seen normal) within 24 hours
• Large vessel occlusion (LVO) involving the intracranial internal carotid artery (ICA), middle cerebral artery (MCA) M1 or M2 segments, basilar or vertebral artery
• Target occlusion can be accessed by the Medtronic React 71 aspiration catheter

You may not qualify if:

• Known or suspected intracranial atherosclerotic disease (ICAD)
• Tandem occlusions

Sponsors & Collaborators

• RapidPulse, Inc: lead

Study Sites (2)

National Institute of Surgery

Tbilisi, Georgia

Location

Pineo Medical Ecosystems

Tbilisi, Georgia

Location

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Interventions

Thrombectomy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Raul G Nogueira, MD

  University of Pittsburgh Medical Center Stroke Institute

  STUDY CHAIR

Study Design

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

Model Details: Prospective, multi-center, open-label, single-arm study to assess the initial technical effectiveness and safety of the RapidPulseTM (feasibility version). As such, no formal statistical hypothesis will be tested in this study.

Study Record Dates

• First Submitted: October 6, 2022
• First Posted: October 13, 2022
• Study Start: April 23, 2023
• Primary Completion: June 3, 2023
• Study Completion: June 13, 2023
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

GE (2)