Prospective Registry for Assessment of Acute Ischemic Stroke Patients Treated With Neurothrombectomy Devices in India

Acute Ischemic Stroke Clinical Trial

— PRAAN  

Official title:

Prospective Registry for Assessment of Acute Ischemic Stroke Patients Treated With Neurothrombectomy Devices in India

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05005962
• Other study ID #: MDT20026
• Status: Completed
• Start date: August 30, 2021
• Est. completion date: May 21, 2024

Study information

• Verified date: May 2024
• Source: Medtronic Neurovascular Clinical Affairs
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 21, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Device:
• Neurothrombectomy
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.

Locations

Country	Name	City	State
India	Sterling Hospital	Ahmadabad	Gujarat
India	Narayana Hrudayalaya	Bengaluru	Karnataka
India	NIMHANS	Bengaluru	Karnataka
India	SRMC	Chennai	Tamil Nadu
India	Kovai Medical Center & Hospital	Coimbatore	Tamil Nadu
India	Artemis Hospital	Gurgaon	Haryana
India	Medanta	Gurgaon	Haryana
India	Rabindranath Tagore International Institute of Cardiac Sciences	Kolkata	WEST Bengal
India	CMC Ludhiana	Ludhiana	Punjab
India	Breach Candy Hospital	Mumbai	Maharashtra
India	HN Reliance	Mumbai	Maharashtra
India	Sir Gangaram Hospital	New Delhi
India	Yashoda Hospital	Secunderabad	Hyderabad
India	Sree Chitra Tirunal Institute for Medical Sciences & Technology	Thiruvananthapuram	Kerala

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Neurovascular Clinical Affairs

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance Evaluation	Time to revascularization and revascularization assessment at the end of the procedure using mTICI score	During the Procedure
Primary	Efficacy Evaluation	NIHSS at day 7 or discharge, whichever comes first; mRS at discharge or day 7; mRS and NIHSS score at 90 days post index stroke procedure	Day 7/Discharge after the procedure & 3 month after the procedure
Primary	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
Secondary	Health Economic analysis of neurothrombectomy procedure in the treatment of patients suffering with ACUTE ISCHEMIC STROKE	Post-acute discharge disposition: discharge to home or any other facility; Subject disposition at study exit; Cost effectiveness: Evaluation of cost effectiveness of Solitaire and/or React Aspiration catheters family of devices will be performed without a statistical test. Therefore, there is no hypothesis test for this ancillary objective. Cost effectiveness will be calculated using a credible model with inputs from the PRAAN study wherever possible (e.g., age, mortality, quality of life). When direct input from the study is not possible, inputs will be derived from prior clinical evidence, from localized outcomes research (within region of from comparable region), or from expert advisory board input. A separate document will outline the plan for evaluating the cost-effectiveness component. Cost effectiveness will be expressed as incremental cost in local currency per quality adjusted life year gained (QALY).	At subject discharge after the procedure and 3 month after the procedure