NCT05005962Completed
Prospective Registry for Assessment of Acute Ischemic Stroke Patients Treated With Neurothrombectomy Devices in India
Source: ClinicalTrials.gov · Last updated 30 May 2024
Brief summary (registry, in English)
PRAAN is a post-market registry designed to collect real-world data associated with the use of Medtronic market release neurothrombectomy devices in acute ischemic stroke (AIS) patients from India.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 200 (actual)
- First submitted
- 29 Jun 2021
- Start date
- 30 Aug 2021
- Primary completion date
- 31 Jan 2024
- Lead sponsor
- Medtronic Neurovascular Clinical Affairs
- Diseases
- Stroke
- NCT number
- NCT05005962
What you commit to
- Study type: Observational
- Participants enrolled: 200
- From 30 Aug 2021 to the primary completion date, 31 Jan 2024
- 14 sites 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.
Prior treatment
- Concurrent participation in another mechanical neurothrombectomy device trial or any other clinical trial with an active treatment arm or where the study procedure or treatment might confound the study analysis
Other
- Patients meeting the contraindication as mentioned in the IFU of devices.
- Significant mass effect with midline shift
Who the study is looking for
- Subject/subject's legally authorized representative has given Informed Consent according to country regulations, and/or EC requirements
- Subject is 18 years of age or older
- Subject has experienced an Acute Ischemic Stroke due to large intracranial vessel occlusion in at least one of the following intracranial vessels: internal carotid artery (ICA), M1 and M2 segments of the middle cerebral artery (MCA), basilar, and vertebral arteries
- Subject has been or will be treated with a Medtronic market-released neuro thrombectomy device as the initial device used to remove the thrombus
- Subject is willing to participate in a 90-day follow-up visit
- Treatment within 24 hours of last known well. For subjects with stroke onset \>6 hours:
- ASPECTS score \>5 (per DW-MRI) or \>6 (per NCCT)
- NCCT Core Infarct \< 70 ml or MRI DWI with \< 70 ml core volume or CTP Ratio of volume of ischemic tissue (penumbra) to infarction of ≥1.8 and an absolute volume of potentially reversible ischemia of ≥15ml
- Pre-Stroke Modified Rankin Scale (mRS) score ≤1 (immediately) prior to stroke onset
- Pre-treatment National Institutes of Health Stroke Scale (NIHSS)
- ≥6 and ≤30 for patients with ≤6 hours of stroke onset.
- ≥10 and ≤30 for patients with \>6 hours of stroke onset.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (14)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sterling Hospital Coordinator of this site? Confirm its status | Ahmedabad | India | Unknown status |
| NIMHANS Coordinator of this site? Confirm its status | Bengaluru | India | Unknown status |
| Narayana Hrudayalaya Coordinator of this site? Confirm its status | Bengaluru | India | Unknown status |
| SRMC Coordinator of this site? Confirm its status | Chennai | India | Unknown status |
| Kovai Medical Center & Hospital Coordinator of this site? Confirm its status | Coimbatore | India | Unknown status |
| Artemis hospital Coordinator of this site? Confirm its status | Gurgaon | India | Unknown status |
| Medanta Coordinator of this site? Confirm its status | Gurgaon | India | Unknown status |
| Rabindranath Tagore International Institute of Cardiac Sciences Coordinator of this site? Confirm its status | Kolkata | India | Unknown status |
| CMC Ludhiana Coordinator of this site? Confirm its status | Ludhiana | India | Unknown status |
| HN Reliance Coordinator of this site? Confirm its status | Mumbai | India | Unknown status |
| Breach Candy Hospital Coordinator of this site? Confirm its status | Mumbai | India | Unknown status |
| Sir Gangaram Hospital Coordinator of this site? Confirm its status | New Delhi | India | Unknown status |
| Yashoda Hospital Coordinator of this site? Confirm its status | Secunderabad | India | Unknown status |
| Sree Chitra Tirunal Institute for Medical Sciences & Technology Coordinator of this site? Confirm its status | Thiruvananthapuram | India | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.