Stroke Clinical Trial
— PULSE-COfficial title:
PULSE-C: Early Feasibility Study of RapidPulseTM Aspiration System as Frontline Approach for Patients With Acute Ischemic Stroke Due to Large Vessel Occlusions
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 |
Verified date | June 2024 |
Source | RapidPulse, Inc |
Contact | Cynthia Yang |
Phone | 9498367402 |
cyang[@]rapidpulsemed.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
RapidPulse, Inc |
Brazil, Paraguay, Turkey,
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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