NCT05899036Completed
Early Feasibility Study of RapidPulseTM Aspiration System for Patients With Acute Ischemic Stroke
PULSE-C: Early Feasibility Study of RapidPulseTM Aspiration System as Frontline Approach for Patients With Acute Ischemic Stroke Due to Large Vessel Occlusions
Source: ClinicalTrials.gov · Last updated 22 Jan 2025
Brief summary (registry, in English)
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 (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 19 (actual)
- First submitted
- 16 May 2023
- Start date
- 23 Mar 2024
- Primary completion date
- 22 Oct 2024
- Lead sponsor
- RapidPulse, Inc
- Diseases
- Stroke
- NCT number
- NCT05899036
What you commit to
- Study type: Interventional
- Participants enrolled: 19
- From 23 Mar 2024 to the primary completion date, 22 Oct 2024
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Known or suspected ICAD
- Tandem occlusions
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital de Clinicas Facultad de Medicina-Universidad Nacional de Asunción Coordinator of this site? Confirm its status | Asunción | Paraguay | Unknown status |
| İstanbul Aydın Üniversitesi V.M Medical Park Florya Hastanesi Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.