Acute Ischemic StrokeRECANOVANCT07599904
REal-world Clinical evAulation of Medtronic NeurOVascular Products for Acute Ischemic Stroke (RECANOVA Registry)
An observational study of Acute Ischemic Stroke, run by Medtronic Neurovascular Clinical Affairs at 3 sites in United States.
Trial summary
Post-Market Registry Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Mechanical Thrombectomy
- Type of treatment
- Medical device
- How many people
- 1,500 participants
- Where
- 3 sitesUnited States
- Study dates
- 13 Jul 2026to Jul 2031
- How long will I take part?
- 90 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Patients requiring treatment with Medtronic Neurovascular commercially available devices used during the treatment of acute ischemic stroke (AIS)
Who may be able to join
- Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements.
- Participant is treated or intended to be treated with a commercially available Medtronic Neurovascular device* during treatment for acute ischemic stroke.
- Participant is 18 years of age or older.
Who cannot join
- Participant who may be unable to complete follow-up within the registry.
- Participant of child-bearing potential who is known to be pregnant or is breastfeeding or wishes to become pregnant during participation in the study.
- Participant is currently enrolled in, or plans to enroll in, any concurrent drug/device study that may confound the study results based on Principal Investigator's discretion.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Buffalo General Medical Center
Buffalo, New York, 14203
Jason Davies, MD, 716-218-1000, jdavies@ubns.com
- Recruiting
McLaren Flint Hospital
Flint, Michigan, 48532
Mahmoud Rayes, MD, 810-342-4071, mahmoud.rayes@mclaren.org
- Recruiting
University of Texas Health Science Center at Houston
Houston, Texas, 77030
Sunil Sheth, MD, 713-500-7897, sunil.a.sheth@uth.tmc.edu
About this study
Post-Market Registry
Read the detailed description
An observational, prospective, multi-center, single-arm registry to provide continuing evaluation of safety and effectiveness of Medtronic Neurovascular commercially available products used in the treatment of acute ischemic stroke.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Mechanical Thrombectomy
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical ThrombectomyDevice
Index stroke procedure and follow-up visits up to 90 days post index procedure
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate device safety
Incidence of Safety Events of Interest through 90-day follow-up
Measured: From Day 0 to 90 days post-procedure
Evaluate device performance
Reperfusion defined as eTICI ≥2b50; ≥2b67; ≥2c; =3 at end of procedure.
Measured: Day 0 - end of index stroke procedure
Evaluate device effectiveness
Functional independence as measured by modified Rankin Scale (mRS) score ≤ 2 at 90-day follow up (mRS scores range from 0 [no symptoms] to 6 [death]).
Measured: From Day 0 to 90 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start13 Jul 2026
- Primary completionJul 2031 (estimated)
- Study completionJul 2031 (estimated)
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
- 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
- NCT07599904
- Sponsor's protocol ID
- RECANOVA Registry
- Acronym
- RECANOVA
- Status last verified
- Jul 2026
- First submitted
- 14 Apr 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REal-world Clinical evAulation of Medtronic NeurOVascular Products for Acute Ischemic Stroke (RECANOVA Registry)
- ClinicalTrials.gov ID
- NCT07599904
- Acronym / sponsor ID
- RECANOVA / RECANOVA Registry
- Conditions
- Acute Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Medtronic Neurovascular Clinical AffairsIndustry (pharma, biotech, devices)
- Study start
- 13 Jul 2026 (actual)
- Primary completion
- Jul 2031 (estimated)
- Study completion
- Jul 2031 (estimated)
- First posted
- 20 May 2026 (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.
Post-Market Registry
Detailed description
An observational, prospective, multi-center, single-arm registry to provide continuing evaluation of safety and effectiveness of Medtronic Neurovascular commercially available products used in the treatment of acute ischemic stroke.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients requiring treatment with Medtronic Neurovascular commercially available devices used during the treatment of acute ischemic stroke (AIS)
Key inclusion criteria (3 listed)
- Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements.
- Participant is treated or intended to be treated with a commercially available Medtronic Neurovascular device* during treatment for acute ischemic stroke.
- Participant is 18 years of age or older.
Key exclusion criteria (3 listed)
- Participant who may be unable to complete follow-up within the registry.
- Participant of child-bearing potential who is known to be pregnant or is breastfeeding or wishes to become pregnant during participation in the study.
- Participant is currently enrolled in, or plans to enroll in, any concurrent drug/device study that may confound the study results based on Principal Investigator's discretion.
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 |
|---|---|---|
| Mechanical ThrombectomyIndex stroke procedure and follow-up visits up to 90 days post index procedure | Device | – |
Primary outcome
Evaluate device safety
Time frame: From Day 0 to 90 days post-procedure
Incidence of Safety Events of Interest through 90-day follow-up
Evaluate device performance
Time frame: Day 0 - end of index stroke procedure
Reperfusion defined as eTICI ≥2b50; ≥2b67; ≥2c; =3 at end of procedure.
Evaluate device effectiveness
Time frame: From Day 0 to 90 days post-procedure
Functional independence as measured by modified Rankin Scale (mRS) score ≤ 2 at 90-day follow up (mRS scores range from 0 [no symptoms] to 6 [death]).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
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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.
3 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 3 sites in United States.
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 3 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: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Salisbury (612-979-7251, rs.recanovaregistry@medtronic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate device safety (time frame: From Day 0 to 90 days post-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 28 Jul 2026.