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Medina Embolization Device In Neurovascular Aneurysm Study (MEDINA)

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Medtronic

Status

Terminated

Conditions

Intracranial Aneurysm

Study type

Observational

Funder types

Industry

Identifiers

NCT02982200
NV-MED-01

Details and patient eligibility

About

A global prospective, multi-center, single-arm, post-market clinical follow-up (PMCF) study conducted to assess the performance of the Medina Embolization Device when used in unruptured and ruptured intracranial aneurysms.

Enrollment

15 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Subject has provided written informed consent using the Ethics Committee-approved consent form and agrees to comply with protocol requirements
  • Subject is 18- 85 years old
  • Subject has a ruptured or unruptured saccular intra-cranial aneurysm amenable to be treated with the Medina Embolization Device

Exclusion criteria

  • Aneurysm is partially thrombosed
  • Aneurysm has been previously treated with surgery or endovascular therapy
  • Subject has had major brain surgery including endovascular procedures within the past 30 days
  • Vessel characteristics (tortuosity, stenosis, morphology) preclude safe endovascular access to the aneurysm
  • Subject is pregnant or breast-feeding or wishes to become pregnant during the length of the study participation
  • The Investigator determines that the validity of the study outcomes may be compromised by the subject's enrollment

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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