Acute Ischemic StrokePRAANNCT05005962
Prospective Registry for Assessment of Acute Ischemic Stroke Patients Treated With Neurothrombectomy Devices in India
An observational study of Acute Ischemic Stroke, run by Medtronic Neurovascular Clinical Affairs at 14 sites in India.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Neurothrombectomy
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 14 sitesIndia
- Study dates
- 30 Aug 2021to 21 May 2024
- How long will I take part?
- 90 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Up to 200 subjects from 15 sites in India
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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
- Patients meeting the contraindication as mentioned in the IFU of devices.
- Significant mass effect with midline shift
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
India14 sites
Sterling Hospital
Ahmedabad, Gujarat
Narayana Hrudayalaya
Bengaluru, Karnataka, 560099
NIMHANS
Bengaluru, Karnataka
SRMC
Chennai, Tamil Nadu
Kovai Medical Center & Hospital
Coimbatore, Tamil Nadu, 641014
Artemis Hospital
Gurgaon, Haryana, 122001
Medanta
Gurgaon, Haryana
Rabindranath Tagore International Institute of Cardiac Sciences
Kolkata, West Bengal, 700099
CMC Ludhiana
Ludhiana, Punjab, 141008
Breach Candy Hospital
Mumbai, Maharashtra
HN Reliance
Mumbai, Maharashtra
Sir Gangaram Hospital
New Delhi
Yashoda Hospital
Secunderabad, Hyderabad
Sree Chitra Tirunal Institute for Medical Sciences & Technology
Thiruvananthapuram, Kerala, 695011
About this study
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.
Read the 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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Neurothrombectomy
- Keywords
- Acute Ischemic Stroke, Neurothrombectomy, Revascularization
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurothrombectomyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Neurothrombectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance Evaluation
Time to revascularization and revascularization assessment at the end of the procedure using mTICI score
Measured: During the Procedure
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
Measured: 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
Measured: from index procedure till 3 month after the procedure performed
Secondary outcomes (1)
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).
Measured: At subject discharge after the procedure and 3 month after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start30 Aug 2021
- Primary completion31 Jan 2024
- Study completion21 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Medtronic Neurovascular Clinical Affairs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05005962
- Sponsor's protocol ID
- MDT20026
- Acronym
- PRAAN
- Status last verified
- May 2024
- First submitted
- 29 Jun 2021
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Registry for Assessment of Acute Ischemic Stroke Patients Treated With Neurothrombectomy Devices in India
- ClinicalTrials.gov ID
- NCT05005962
- Acronym / sponsor ID
- PRAAN / MDT20026
- Conditions
- Acute Ischemic Stroke
- Keywords
- Acute Ischemic Stroke, Neurothrombectomy, Revascularization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Medtronic Neurovascular Clinical AffairsIndustry (pharma, biotech, devices)
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 21 May 2024 (actual)
- First posted
- 16 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute ischemic patients suffering with stroke | – | Device: NeurothrombectomyAcute 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Up to 200 subjects from 15 sites in India
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (3 listed)
- 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
- Patients meeting the contraindication as mentioned in the IFU of devices.
- Significant mass effect with midline shift
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeurothrombectomyNeurothrombectomy 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. | Device | Acute ischemic patients suffering with stroke |
Primary outcome
Performance Evaluation
Time frame: During the Procedure
Time to revascularization and revascularization assessment at the end of the procedure using mTICI score
Efficacy Evaluation
Time frame: Day 7/Discharge after the procedure & 3 month after the procedure
1. NIHSS at day 7 or discharge, whichever comes first 2. mRS at discharge or day 7 3. mRS and NIHSS score at 90 days post index stroke procedure
Safety Evaluation
Time frame: from index procedure till 3 month after the procedure performed
Incidence of Neurological Events of Interest, All-cause mortality, Procedure-related AEs, Device-related AEs, and all SAEs
1 secondary outcome
Health Economic analysis of neurothrombectomy procedure in the treatment of patients suffering with ACUTE ISCHEMIC STROKE
Time frame: At subject discharge after the procedure and 3 month after the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke, run by Medtronic Neurovascular Clinical Affairs at 14 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance Evaluation (time frame: During the Procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2024.