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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.
The objective of this registry is to access clinical outcomes associated with the use of these device in patients experiencing the AIS due to large intracranial vessel occlusion within 8 hours of last known well.
Real-world evidence per Standard-of-care (SOC) will be generated using Medtronic neurothrombectomy devices approved in India, using on-label indications for use in this post-market clinical follow-up registry.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acute ischemic patients suffering with stroke | Acute ischemic patients treated with commercially available neurothrombectomy devices in India. The device can be either a stent retriever or aspiration catheter to treat the stroke as per the labeling indications of the products. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neurothrombectomy | Device | Neurothrombectomy device will be used to treat patients experiencing the AIS due to large intracranial vessel occlusion within 8 hours of last known well to collect real-world data and to access clinical outcomes associated with the use of these devices. |
| Measure | Description | Time Frame |
|---|---|---|
| Performance Evaluation | Time to revascularization and revascularization assessment at the end of the procedure using mTICI score | During the Procedure |
| Efficacy Evaluation |
| Day 7/Discharge after the procedure & 3 month after the procedure |
| Safety Evaluation | Incidence of Neurological Events of Interest, All-cause mortality, Procedure-related AEs, Device-related AEs, and all SAEs | from index procedure till 3 month after the procedure performed |
| Measure | Description | Time Frame |
|---|---|---|
| Health Economic analysis of neurothrombectomy procedure in the treatment of patients suffering with ACUTE ISCHEMIC STROKE |
|
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Inclusion Criteria:
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:
Pre-Stroke Modified Rankin Scale (mRS) score ≤1 (immediately) prior to stroke onset
Pre-treatment National Institutes of Health Stroke Scale (NIHSS)
Exclusion Criteria:
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Up to 200 subjects from 15 sites in India
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sterling Hospital | Ahmedabad | Gujarat | India | |||
| Artemis Hospital |
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|
| At subject discharge after the procedure and 3 month after the procedure |
| Gurgaon |
| Haryana |
| 122001 |
| India |
| Medanta | Gurgaon | Haryana | India |
| Yashoda Hospital | Secunderabad | Hyderabad | India |
| Narayana Hrudayalaya | Bengaluru | Karnataka | 560099 | India |
| NIMHANS | Bengaluru | Karnataka | India |
| Sree Chitra Tirunal Institute for Medical Sciences & Technology | Thiruvananthapuram | Kerala | 695011 | India |
| Breach Candy Hospital | Mumbai | Maharashtra | India |
| HN Reliance | Mumbai | Maharashtra | India |
| CMC Ludhiana | Ludhiana | Punjab | 141008 | India |
| SRMC | Chennai | Tamil Nadu | India |
| Kovai Medical Center & Hospital | Coimbatore | Tamil Nadu | 641014 | India |
| Rabindranath Tagore International Institute of Cardiac Sciences | Kolkata | West Bengal | 700099 | India |
| Sir Gangaram Hospital | New Delhi | India |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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