Clinical trial NCT05005962: Prospective Registry for Assessment of Acute Ischemic Stroke Patients Treated With Neurothrombectomy Devices in India
Official title: Prospective Registry for Assessment of Acute Ischemic Stroke Patients Treated With Neurothrombectomy Devices in India
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Ischemic Stroke
Keywords: Acute Ischemic Stroke
Neurothrombectomy
Revascularization
Lead sponsor: Medtronic Neurovascular Clinical Affairs
Sponsor class: INDUSTRY
First posted: 2021-08-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Up to 200 subjects from 15 sites in India

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Subject/subject's legally authorized representative has given Informed Consent according to country regulations, and/or EC requirements
2. Subject is 18 years of age or older
3. 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
4. Subject has been or will be treated with a Medtronic market-released neuro thrombectomy device as the initial device used to remove the thrombus
5. Subject is willing to participate in a 90-day follow-up visit
6. 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
7. Pre-Stroke Modified Rankin Scale (mRS) score ≤1 (immediately) prior to stroke onset
8. 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.

Exclusion Criteria:

1. 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
2. Patients meeting the contraindication as mentioned in the IFU of devices.
3. Significant mass effect with midline shift

Primary outcomes:
measure: Performance Evaluation
timeFrame: During the Procedure
measure: Efficacy Evaluation
timeFrame: Day 7/Discharge after the procedure & 3 month after the procedure
measure: Safety Evaluation
timeFrame: from index procedure till 3 month after the procedure performed
Secondary outcomes:
measure: Health Economic analysis of neurothrombectomy procedure in the treatment of patients suffering with ACUTE ISCHEMIC STROKE
timeFrame: At subject discharge after the procedure and 3 month after the procedure
Other outcomes:
Locations:
city: Ahmadabad
country: India
facility: Sterling Hospital
state: Gujarat
city: Gurgaon
country: India
facility: Artemis Hospital
state: Haryana
city: Gurgaon
country: India
facility: Medanta
state: Haryana
city: Secunderabad
country: India
facility: Yashoda Hospital
state: Hyderabad
city: Bengaluru
country: India
facility: Narayana Hrudayalaya
state: Karnataka
city: Bengaluru
country: India
facility: NIMHANS
state: Karnataka
city: Thiruvananthapuram
country: India
facility: Sree Chitra Tirunal Institute for Medical Sciences & Technology
state: Kerala
city: Mumbai
country: India
facility: Breach Candy Hospital
state: Maharashtra
city: Mumbai
country: India
facility: HN Reliance
state: Maharashtra
city: Ludhiāna
country: India
facility: CMC Ludhiana
state: Punjab
city: Chennai
country: India
facility: SRMC
state: Tamil Nadu
city: Coimbatore
country: India
facility: Kovai Medical Center & Hospital
state: Tamil Nadu
city: Kolkata
country: India
facility: Rabindranath Tagore International Institute of Cardiac Sciences
state: WEST Bengal
city: New Delhi
country: India
facility: Sir Gangaram Hospital
Study officials:
References: