Intracranial AneurysmMEDINANCT02982200
Medina Embolization Device In Neurovascular Aneurysm Study
An observational study of Intracranial Aneurysm, run by Medtronic Neurovascular Clinical Affairs at 3 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Intracranial Aneurysm
- How many people
- 15 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 15 Dec 2016to 22 Oct 2018
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Saccular intracranial aneurysm not previously treated.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Austria1 site
Universitätsklinikum Christian Doppler Klinik Salzburg
Salzburg, 5020
About this study
Official title: The MEDINA Study: Medina Embolization Device In Neurovascular Aneurysms Study - A Post Market Clinical Follow-up Study
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.
- Conditions
- Intracranial Aneurysm
- Keywords
- Embolization Device, Medina, Rupture Intracranial Aneurysm, Unrupture Intracranial Aneurysm
- Medical subject headings
- Intracranial Aneurysm
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete aneurysm occlusion as defined by the Modified Raymond-Roy Classification (MRRC)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study start15 Dec 2016
- Primary completion22 Oct 2018
- Study completion22 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Intracranial AneurysmStudies 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Neurovascular Clinical Affairs
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medtronic Cardiac Rhythm and Heart Failure
- Responsible party
- Sponsor
- Investigators
- Patrick Brouwer, Dr, Study chair, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02982200
- Sponsor's protocol ID
- NV-MED-01
- Acronym
- MEDINA
- Status last verified
- May 2019
- First submitted
- 1 Dec 2016
- Last updated
- 17 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Inagawa T, Hirano A. Autopsy study of unruptured incidental intracranial aneurysms. Surg Neurol. 1990 Dec;34(6):361-5. doi: 10.1016/0090-3019(90)90237-j.
PubMed 2244298Agarwal N, Gala NB, Choudhry OJ, Assina R, Prestigiacomo CJ, Duffis EJ, Gandhi CD. Prevalence of asymptomatic incidental aneurysms: a review of 2,685 computed tomographic angiograms. World Neurosurg. 2014 Dec;82(6):1086-90. doi: 10.1016/j.wneu.2013.01.082. Epub 2013 Jan 19.
PubMed 23336985Winn HR, Jane JA Sr, Taylor J, Kaiser D, Britz GW. Prevalence of asymptomatic incidental aneurysms: review of 4568 arteriograms. J Neurosurg. 2002 Jan;96(1):43-9. doi: 10.3171/jns.2002.96.1.0043.
PubMed 11794602Schievink WI. Intracranial aneurysms. N Engl J Med. 1997 Jan 2;336(1):28-40. doi: 10.1056/NEJM199701023360106. No abstract available.
PubMed 8970938Bonneville F, Sourour N, Biondi A. Intracranial aneurysms: an overview. Neuroimaging Clin N Am. 2006 Aug;16(3):371-82, vii. doi: 10.1016/j.nic.2006.05.001.
PubMed 16935705Gemmete JJ, Elias AE, Chaudhary N, Pandey AS. Endovascular methods for the treatment of intracranial cerebral aneurysms. Neuroimaging Clin N Am. 2013 Nov;23(4):563-91. doi: 10.1016/j.nic.2013.03.007. Epub 2013 May 25.
PubMed 24156851Wiebers DO, Whisnant JP, Huston J 3rd, Meissner I, Brown RD Jr, Piepgras DG, Forbes GS, Thielen K, Nichols D, O'Fallon WM, Peacock J, Jaeger L, Kassell NF, Kongable-Beckman GL, Torner JC; International Study of Unruptured Intracranial Aneurysms Investigators. Unruptured intracranial aneurysms: natural history, clinical outcome, and risks of surgical and endovascular treatment. Lancet. 2003 Jul 12;362(9378):103-10. doi: 10.1016/s0140-6736(03)13860-3.
PubMed 12867109UCAS Japan Investigators; Morita A, Kirino T, Hashi K, Aoki N, Fukuhara S, Hashimoto N, Nakayama T, Sakai M, Teramoto A, Tominari S, Yoshimoto T. The natural course of unruptured cerebral aneurysms in a Japanese cohort. N Engl J Med. 2012 Jun 28;366(26):2474-82. doi: 10.1056/NEJMoa1113260.
PubMed 22738097Roy D, Milot G, Raymond J. Endovascular treatment of unruptured aneurysms. Stroke. 2001 Sep;32(9):1998-2004. doi: 10.1161/hs0901.095600.
PubMed 11546888Zuccarello M. Treatment strategy for patients with unruptured intracranial aneurysms. Neurol Med Chir (Tokyo). 2001 Dec;41(12):571-5. doi: 10.2176/nmc.41.571.
PubMed 11803581Broderick JP, Brott TG, Duldner JE, Tomsick T, Leach A. Initial and recurrent bleeding are the major causes of death following subarachnoid hemorrhage. Stroke. 1994 Jul;25(7):1342-7. doi: 10.1161/01.str.25.7.1342.
PubMed 8023347Johnston SC, Higashida RT, Barrow DL, Caplan LR, Dion JE, Hademenos G, Hopkins LN, Molyneux A, Rosenwasser RH, Vinuela F, Wilson CB; Committee on Cerebrovascular Imaging of the American Heart Association Council on Cardiovascular Radiology. Recommendations for the endovascular treatment of intracranial aneurysms: a statement for healthcare professionals from the Committee on Cerebrovascular Imaging of the American Heart Association Council on Cardiovascular Radiology. Stroke. 2002 Oct;33(10):2536-44. doi: 10.1161/01.str.0000034708.66191.7d. No abstract available.
PubMed 12364750Raaymakers TW, Rinkel GJ, Limburg M, Algra A. Mortality and morbidity of surgery for unruptured intracranial aneurysms: a meta-analysis. Stroke. 1998 Aug;29(8):1531-8. doi: 10.1161/01.str.29.8.1531.
PubMed 9707188Lanzino G, Murad MH, d'Urso PI, Rabinstein AA. Coil embolization versus clipping for ruptured intracranial aneurysms: a meta-analysis of prospective controlled published studies. AJNR Am J Neuroradiol. 2013 Sep;34(9):1764-8. doi: 10.3174/ajnr.A3515. Epub 2013 Apr 11.
PubMed 23578672Vanninen R, Koivisto T, Saari T, Hernesniemi J, Vapalahti M. Ruptured intracranial aneurysms: acute endovascular treatment with electrolytically detachable coils--a prospective randomized study. Radiology. 1999 May;211(2):325-36. doi: 10.1148/radiology.211.2.r99ap06325.
PubMed 10228510
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The MEDINA Study: Medina Embolization Device In Neurovascular Aneurysms Study - A Post Market Clinical Follow-up Study
- ClinicalTrials.gov ID
- NCT02982200
- Acronym / sponsor ID
- MEDINA / NV-MED-01
- Conditions
- Intracranial Aneurysm
- Keywords
- Embolization Device, Medina, Rupture Intracranial Aneurysm, Unrupture Intracranial Aneurysm
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Medtronic Neurovascular Clinical AffairsIndustry (pharma, biotech, devices)
- Collaborators
- Medtronic Cardiac Rhythm and Heart Failure
- Study start
- 15 Dec 2016 (actual)
- Primary completion
- 22 Oct 2018 (actual)
- Study completion
- 22 Oct 2018 (actual)
- First posted
- 5 Dec 2016 (estimated)
- 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Saccular intracranial aneurysm not previously treated.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Complete aneurysm occlusion as defined by the Modified Raymond-Roy Classification (MRRC)
Time frame: 12 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2019.
- Background: PubMed 2244298Inagawa T, Hirano A. Autopsy study of unruptured incidental intracranial aneurysms. Surg Neurol. 1990 Dec;34(6):361-5. doi: 10.1016/0090-3019(90)90237-j.
- Background: PubMed 23336985Agarwal N, Gala NB, Choudhry OJ, Assina R, Prestigiacomo CJ, Duffis EJ, Gandhi CD. Prevalence of asymptomatic incidental aneurysms: a review of 2,685 computed tomographic angiograms. World Neurosurg. 2014 Dec;82(6):1086-90. doi: 10.1016/j.wneu.2013.01.082. Epub 2013 Jan 19.
- Background: PubMed 11794602Winn HR, Jane JA Sr, Taylor J, Kaiser D, Britz GW. Prevalence of asymptomatic incidental aneurysms: review of 4568 arteriograms. J Neurosurg. 2002 Jan;96(1):43-9. doi: 10.3171/jns.2002.96.1.0043.
- Background: PubMed 8970938Schievink WI. Intracranial aneurysms. N Engl J Med. 1997 Jan 2;336(1):28-40. doi: 10.1056/NEJM199701023360106. No abstract available.
- Background: PubMed 16935705Bonneville F, Sourour N, Biondi A. Intracranial aneurysms: an overview. Neuroimaging Clin N Am. 2006 Aug;16(3):371-82, vii. doi: 10.1016/j.nic.2006.05.001.
- Background: PubMed 24156851Gemmete JJ, Elias AE, Chaudhary N, Pandey AS. Endovascular methods for the treatment of intracranial cerebral aneurysms. Neuroimaging Clin N Am. 2013 Nov;23(4):563-91. doi: 10.1016/j.nic.2013.03.007. Epub 2013 May 25.
- Background: PubMed 12867109Wiebers DO, Whisnant JP, Huston J 3rd, Meissner I, Brown RD Jr, Piepgras DG, Forbes GS, Thielen K, Nichols D, O'Fallon WM, Peacock J, Jaeger L, Kassell NF, Kongable-Beckman GL, Torner JC; International Study of Unruptured Intracranial Aneurysms Investigators. Unruptured intracranial aneurysms: natural history, clinical outcome, and risks of surgical and endovascular treatment. Lancet. 2003 Jul 12;362(9378):103-10. doi: 10.1016/s0140-6736(03)13860-3.
- Background: PubMed 22738097UCAS Japan Investigators; Morita A, Kirino T, Hashi K, Aoki N, Fukuhara S, Hashimoto N, Nakayama T, Sakai M, Teramoto A, Tominari S, Yoshimoto T. The natural course of unruptured cerebral aneurysms in a Japanese cohort. N Engl J Med. 2012 Jun 28;366(26):2474-82. doi: 10.1056/NEJMoa1113260.
- Background: PubMed 11546888Roy D, Milot G, Raymond J. Endovascular treatment of unruptured aneurysms. Stroke. 2001 Sep;32(9):1998-2004. doi: 10.1161/hs0901.095600.
- Background: PubMed 11803581Zuccarello M. Treatment strategy for patients with unruptured intracranial aneurysms. Neurol Med Chir (Tokyo). 2001 Dec;41(12):571-5. doi: 10.2176/nmc.41.571.
- Background: PubMed 8023347Broderick JP, Brott TG, Duldner JE, Tomsick T, Leach A. Initial and recurrent bleeding are the major causes of death following subarachnoid hemorrhage. Stroke. 1994 Jul;25(7):1342-7. doi: 10.1161/01.str.25.7.1342.
- Background: PubMed 12364750Johnston SC, Higashida RT, Barrow DL, Caplan LR, Dion JE, Hademenos G, Hopkins LN, Molyneux A, Rosenwasser RH, Vinuela F, Wilson CB; Committee on Cerebrovascular Imaging of the American Heart Association Council on Cardiovascular Radiology. Recommendations for the endovascular treatment of intracranial aneurysms: a statement for healthcare professionals from the Committee on Cerebrovascular Imaging of the American Heart Association Council on Cardiovascular Radiology. Stroke. 2002 Oct;33(10):2536-44. doi: 10.1161/01.str.0000034708.66191.7d. No abstract available.
Related trials for Intracranial Aneurysm
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
RecruitingObservational study
Determining the Clinical Impact and Prevalence of Hemorrhagic Subtypes in Perimesencephalic Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Spontaneous, Subarachnoid Hemorrhage, Aneurysmal
Not yet recruitingPhase 1/2
Induced Suppression of Platelet Activity in Aneurysmal Subarachnoid Hemorrhage Management-2 (iSPASM-2)
Aneurysmal Subarachnoid Hemorrhage
RecruitingObservational study
A Study of Choydar Flow-Directed Mesh Stent in the Treatment of Unruptured Intracranial Aneurysms
Intracranial Aneurysm
Not yet recruiting
Effect of Bilateral Greater Occipital Nerve Block on Headache After Intracranial Aneurysm Coiling
Intracranial Aneurysm, Postoperative Pain
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.
Patrick Brouwer, Dr study chair
Karolinska University Hospital
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Aneurysm, run by Medtronic Neurovascular Clinical Affairs at 3 sites in 3 countries.
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 6 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: stopped early, as of the sponsor's last update on 17 May 2019. 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 Austria, Italy, Spain. 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 was stopped early. Results are not available in the source record.
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?
Complete aneurysm occlusion as defined by the Modified Raymond-Roy Classification (MRRC) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02982200, which also lists 30 linked publications.
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 17 May 2019.