Clinical trial NCT05899036: Early Feasibility Study of RapidPulseTM Aspiration System for Patients With Acute Ischemic Stroke
Official title: PULSE-C: Early 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
Stroke
Large Vessel Occlusion
Mechanical Thrombectomy
Keywords: Stroke
Mechanical Thrombectomy
Lead sponsor: RapidPulse, Inc
Sponsor class: INDUSTRY
First posted: 2023-06-12
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, multi-center, open-label, single-arm study to assess the initial technical (performance), effectiveness, and safety of the RapidPulseTM Aspiration System. As such, no formal statistical hypothesis will be tested in this study.
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: First Pass Reperfusion Effect (FPE)
timeFrame: Intra-procedural
Secondary outcomes:
Other outcomes:
measure: Frontline technical success
timeFrame: Intra-procedural
measure: Final mTICI score
timeFrame: Intra-procedural
measure: Modified First Pass Reperfusion Effect (mFPE)
timeFrame: Intra-procedural
measure: Device-related and procedure-related adverse events
timeFrame: Intra and post procedural (up to Day 5-7 or discharge whichever occurs earlier)
Locations:
city: Asunción
country: Paraguay
facility: Hospital de Clinicas Facultad de Medicina-Universidad Nacional de Asunción
city: İstanbul
country: Turkey
facility: İstanbul Aydın Üniversitesi V.M Medical Park Florya Hastanesi
Study officials:
affiliation: University of Pittsburgh Medical Center Stroke Institute
name: Raul G Nogueira
role: STUDY_CHAIR
References: