REal-world Clinical evAulation of Medtronic NeurOVascular Products for Acute Ischemic Stroke (RECANOVA Registry)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedtronic Neurovascular Clinical Affairs

About this trial

Post-Market Registry

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 population

Patients requiring treatment with Medtronic Neurovascular commercially available devices used during the treatment of acute ischemic stroke (AIS)

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Mechanical Thrombectomy

    Device

    Index stroke procedure and follow-up visits up to 90 days post index procedure

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Evaluate device safety

Incidence of Safety Events of Interest through 90-day follow-up

Time frame
From Day 0 to 90 days post-procedure
2

Evaluate device performance

Reperfusion defined as eTICI ≥2b50; ≥2b67; ≥2c; =3 at end of procedure.

Time frame
Day 0 - end of index stroke procedure
3

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 \[death\]).

Time frame
From Day 0 to 90 days post-procedure

Secondary outcomes

Other outcomes

Sponsors and contacts

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