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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05899036
Other study ID # CIP-0003
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 23, 2024
Est. completion date July 2024

Study information

Verified date June 2024
Source RapidPulse, Inc
Contact Cynthia Yang
Phone 9498367402
Email cyang@rapidpulsemed.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to assess the initial safety and performance of the RapidPulseTM Aspiration System in patients experiencing acute ischemic stroke within 24 hours since the onset of stroke symptoms, or last known normal. Subject will undergo mechanical thrombectomy (a procedure to remove a clot in the brain which is preventing blood flow), with the RapidPulseTM Aspiration System. Participating in the trial is for 5-7 days or hospital discharge (whichever is earlier).


Description:

The purpose of this prospective, multi-center, open label study of the RapidPulseTM Aspiration System is to assess the initial technical (performance), effectiveness and safety of the RapidPulseTM Aspiration System as frontline approach for patients with acute ischemic stroke due to large vessel occlusions identified within 24 hours of symptom onset (or last seen normal). The target sample size is 10 evaluable subjects with a maximum of 50 subjects. Subjects will undergo mechanical thrombectomy procedure and will have postoperative assessments completed at 24 hours and on Day 5-7 or upon hospital discharge. The primary endpoint is first pass reperfusion effect (FPE) as defined by mTICI ≥ 2c after one reperfusion attempt.


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date July 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Clinical diagnosis of acute ischemic stroke with symptom onset (or last seen normal) within 24 hours. - CTA, MRA or DSA demonstrating anterior large vessel occlusion involving the intracranial ICA, MCA M1 or M2 segments, basilar or vertebral artery - Target occlusion can be accessed by the RapidPulseTM 071 aspiration catheter assessed at the time of the index procedure. Enrollment will be defined by the successful navigation of the RapidPulseTM 071 aspiration catheter into the occlusion site. Exclusion Criteria: - Known or suspected ICAD - Tandem occlusions

Study Design


Intervention

Device:
RapidPulseTM Aspiration System
The RapidPulseTM Aspiration System is designed to remove occlusive thrombus from the cerebral vasculature using pulsatile aspiration. The system is comprised of a sterile one-time use 071 catheter, a sterile one-time use tubing set and a multiuse aspiration pump console.

Locations

Country Name City State
Brazil Hospital Geral de Fortaleza Fortaleza
Paraguay Hospital de Clinicas Facultad de Medicina-Universidad Nacional de Asunción Asunción
Turkey Istanbul Aydin Üniversitesi V.M Medical Park Florya Hastanesi Istanbul

Sponsors (1)

Lead Sponsor Collaborator
RapidPulse, Inc

Countries where clinical trial is conducted

Brazil,  Paraguay,  Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Other Frontline technical success The number of subjects with mTICI = 2b after the last pass with Study Device (no rescue therapy) Intra-procedural
Other Final mTICI score The final mTICI score (0-3) for all subjects after all passes (including any rescue therapy) Intra-procedural
Other Modified First Pass Reperfusion Effect (mFPE) The number of subjects with mTICI = 2b after one device pass Intra-procedural
Other Device-related and procedure-related adverse events Including vessel injury, distal emboli, emboli in new territory (ENT) and vessel spasm Intra and post procedural (up to Day 5-7 or discharge whichever occurs earlier)
Primary First Pass Reperfusion Effect (FPE) The number of subjects with mTICI = 2c after one reperfusion attempt Intra-procedural
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