Medina Embolization Device In Neurovascular Aneurysm Study

NCT02982200 | Terminated

• 1 other identifier: NV-MED-01
• Study Type: observational
• Target: 15
• Locations: 3 countries
• Sites: 3

Brief 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.

Conditions

Intracranial Aneurysm

Keywords

Embolization Device; Medina; Rupture Intracranial Aneurysm; Unrupture Intracranial Aneurysm

Outcome Measures

Primary Outcomes (1)

• Complete aneurysm occlusion as defined by the Modified Raymond-Roy Classification (MRRC)

  12 months

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Saccular intracranial aneurysm not previously treated.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Neurovascular Clinical Affairs: lead
• Medtronic Cardiac Rhythm and Heart Failure: collaborator

Study Sites (3)

Universitätsklinikum Christian Doppler Klinik Salzburg

Salzburg, 5020, Austria

Location

Azienda Ospedaliera Ospedale Niguarda Cà Granda

Milan, 20162, Italy

Location

Hospital Fundación Jiménez Díaz

Madrid, 28040, Spain

Location

Related Publications (30)

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• Wiebers 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.

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• Johnston 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.

  PMID: 12364750 BACKGROUND

• Raaymakers 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.

  PMID: 9707188 BACKGROUND

• Lanzino 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.

  PMID: 23578672 BACKGROUND

• Vanninen 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.

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• McDougall CG, Spetzler RF, Zabramski JM, Partovi S, Hills NK, Nakaji P, Albuquerque FC. The Barrow Ruptured Aneurysm Trial. J Neurosurg. 2012 Jan;116(1):135-44. doi: 10.3171/2011.8.JNS101767. Epub 2011 Nov 4.

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• Molyneux A, Kerr R; International Subarachnoid Aneurysm Trial (ISAT) Collaborative Group; Stratton I, Sandercock P, Clarke M, Shrimpton J, Holman R. International Subarachnoid Aneurysm Trial (ISAT) of neurosurgical clipping versus endovascular coiling in 2143 patients with ruptured intracranial aneurysms: a randomized trial. J Stroke Cerebrovasc Dis. 2002 Nov-Dec;11(6):304-14. doi: 10.1053/jscd.2002.130390.

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• Seibert B, Tummala RP, Chow R, Faridar A, Mousavi SA, Divani AA. Intracranial aneurysms: review of current treatment options and outcomes. Front Neurol. 2011 Jul 8;2:45. doi: 10.3389/fneur.2011.00045. eCollection 2011.

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• Im SH, Han MH, Kwon OK, Kwon BJ, Kim SH, Kim JE, Oh CW. Endovascular coil embolization of 435 small asymptomatic unruptured intracranial aneurysms: procedural morbidity and patient outcome. AJNR Am J Neuroradiol. 2009 Jan;30(1):79-84. doi: 10.3174/ajnr.A1290. Epub 2008 Sep 3.

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• Miller TR, Jindal G, Krejza J, Gandhi D. Impact of Endovascular Technique on Fluoroscopy Usage: Stent-Assisted Coiling versus Flow Diversion for Paraclinoid Internal Carotid Artery Aneurysms. Neuroradiol J. 2014 Dec;27(6):725-31. doi: 10.15274/NRJ-2014-10094. Epub 2014 Dec 1.

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• Crobeddu E, Lanzino G, Kallmes DF, Cloft HJ. Review of 2 decades of aneurysm-recurrence literature, part 2: Managing recurrence after endovascular coiling. AJNR Am J Neuroradiol. 2013 Mar;34(3):481-5. doi: 10.3174/ajnr.A2958. Epub 2012 Mar 15.

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• Abdihalim M, Watanabe M, Chaudhry SA, Jagadeesan B, Suri MF, Qureshi AI. Are coil compaction and aneurysmal growth two distinct etiologies leading to recurrence following endovascular treatment of intracranial aneurysm? J Neuroimaging. 2014 Mar-Apr;24(2):171-5. doi: 10.1111/j.1552-6569.2012.00786.x. Epub 2013 Jan 14.

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• Mori K, Nakao Y, Horinaka N, Wada R, Hirano A, Maeda M. Cerebral aneurysm regrowth and coil unraveling after incomplete Guglielmi detachable coil embolization: serial angiographical and histological findings. Neurol Med Chir (Tokyo). 2003 Jun;43(6):293-7. doi: 10.2176/nmc.43.293.

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• Mascitelli JR, Moyle H, Oermann EK, Polykarpou MF, Patel AA, Doshi AH, Gologorsky Y, Bederson JB, Patel AB. An update to the Raymond-Roy Occlusion Classification of intracranial aneurysms treated with coil embolization. J Neurointerv Surg. 2015 Jul;7(7):496-502. doi: 10.1136/neurintsurg-2014-011258. Epub 2014 Jun 4.

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• Rouchaud A, Brinjikji W, Gunderson T, Caroff J, Gentric JC, Lanzino G, Cloft HJ, Kallmes DF. Validity of the Meyer Scale for Assessment of Coiled Aneurysms and Aneurysm Recurrence. AJNR Am J Neuroradiol. 2016 May;37(5):844-8. doi: 10.3174/ajnr.A4616. Epub 2015 Nov 12.

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• McDougall CG, Johnston SC, Gholkar A, Barnwell SL, Vazquez Suarez JC, Masso Romero J, Chaloupka JC, Bonafe A, Wakhloo AK, Tampieri D, Dowd CF, Fox AJ, Imm SJ, Carroll K, Turk AS; MAPS Investigators. Bioactive versus bare platinum coils in the treatment of intracranial aneurysms: the MAPS (Matrix and Platinum Science) trial. AJNR Am J Neuroradiol. 2014 May;35(5):935-42. doi: 10.3174/ajnr.A3857. Epub 2014 Jan 30.

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• Pierot L, Cognard C, Anxionnat R, Ricolfi F; CLARITY Investigators. Endovascular treatment of ruptured intracranial aneurysms: factors affecting midterm quality anatomic results: analysis in a prospective, multicenter series of patients (CLARITY). AJNR Am J Neuroradiol. 2012 Sep;33(8):1475-80. doi: 10.3174/ajnr.A3003. Epub 2012 Apr 19.

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MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Patrick Brouwer, Dr

  Karolinska University Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2016
• First Posted: December 5, 2016
• Study Start: December 15, 2016
• Primary Completion: October 22, 2018
• Study Completion: October 22, 2018
• Last Updated: May 17, 2019

Record last verified: 2019-05

Locations

ES (1); AU (1); IT (1)