NCT05720975Completed
Efficacy and Safety Evaluation of the Thromboaspiration Catheter System iNstroke in Patients With Acute Ischemic Stroke
First Prospective, Single-arm, Single-centre Study to Evaluate the Efficacy and Safety of the Thromboaspiration Catheter System (iNstroke) for Stroke in Patients With Acute Ischemic Stroke
Source: ClinicalTrials.gov · Last updated 9 May 2025
Brief summary (registry, in English)
First prospective, single-arm, single-centre study to evaluate the efficacy and safety of the iNstroke thromboaspiration catheter system (iNstroke) for stroke in patients with acute ischemic stroke.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 113 (actual)
- First submitted
- 21 Jul 2022
- Start date
- 26 Dec 2022
- Primary completion date
- 7 Jan 2025
- Lead sponsor
- iVascular S.L.U.
- Diseases
- Stroke
- NCT number
- NCT05720975
What you commit to
- Study type: Observational
- Participants enrolled: 113
- From 26 Dec 2022 to the primary completion date, 7 Jan 2025
- 1 site in 1 country
- 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 illness
- Serious allergy to contrast medium.
- Patients with intracranial atherosclerotic occlusive disease or extra- or intracranial dissection
Lab values
- Personal history of thrombocytopaenia (\<40,000 platelets)
Age
- Patients under 18 years of age.
Other
- Patients with an ASPECTS score \<6.
- Baseline NIHSS obtained before procedure of ≤ 6 points.
- Severe comorbidity and/or shortened life expectancy
- mRS \> 2.
- Pregnant women.
Who the study is looking for
- Patients with acute ischaemic stroke over 18 years of age caused by large vessel occlusion (TICA, extracranial ICA, M1, vertebral artery segment V4 or basilar artery) and receiving neurointerventional treatment with the iNstroke aspiration catheter.
- Informed consent signed by the patient or their representative, or deferred informed consent to avoid delaying commencement of mechanical thrombectomy.
- Patients with an ASPECTS (Alberta Stroke Program Early CT Score) score ≥ 6
- In patients having onset of stroke more than 8 hours previously, wake-up strokes, or unknown time of onset, treatment must be customised and CT perfusion must show penumbra.
- Initial NIHSS score before procedure \> 6.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario Virgen del Rocio Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.