Clinical Trials in South Korea / NCT02988128
Recruiting
Observational
Neurovascular Product Surveillance Registry
NCT02988128 · tracked via the Priya Life Science South Korea tracker
Condition(s) studied
Intracranial AneurysmStroke, Ischemic
Investigational drug(s) / intervention(s)
Treatment for intracranial aneurysmsTreatment for Acute Ischemic Stroke
Treatment for intracranial aneurysms: Embolization of aneurysms
Treatment for Acute Ischemic Stroke: Revascularization of an intracranial blood vessel
Study summary
Post market surveillance registry
Eligibility
For MDT16056 and MDT17077
Inclusion Criteria:
* Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements
* Patient has, or is intended to receive or be treated with, an eligible Medtronic product
* Patient is consented within the enrollment window of the therapy received, as applicable
* Patient is at least 18 years of age at time of enrollment.
Exclusion Criteria:
* Patient who is, or is expected to be inaccessible for follow-up
* Patient with exclusion criteria required by local law
* Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
* Female patient who is known to be pregnant or is breastfeeding or wishes to become pregnant during participation in the study.
For MDT24028 and MDT22032:
General Inclusion Criteria:
* Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements.
* Patient is treated or intended to be treated with an eligible Medtronic Neurovascular product.
* Patient is an adult per local law at time of consent. Medtronic Business Restricted This document is electronically controlled CONFIDENTIAL 056-F275 Rev F Clinical Investigation Plan Template
General Exclusion Criteria:
* Patient who may be unable to complete the study follow-up
* Patient with any contraindications per the applicable Instructions for Use document
* Female patient who is known to be pregnant or is breastfeeding or wishes to become pregnant during participation in the study
* Patient is currently enrolled in, or plans to enroll in, any concurrent drug/device study that may confound the study results.
Additional criteria may be required, refer to cohort-specific Addendum, as applicable, for further guidance.
Primary outcome measure(s)
- The clinical success rate defined as complete occlusion of target aneurysm without retreatment or significant artery stenosis (≤ 50%). — 1 year
For Intracranial Aneurysm the primary outcome is the clinical success rate defined as complete occlusion of target aneurysm without retreatment or significant artery stenosis (≤ 50%). - Functional Independence: mRS score ≤ 2 — 90 days
For Acute ischemic stroke the primary outcome is functional Independence: modified Rankin Scale (mRS) score ≤ 2
Trial sites (99)
| Facility | City | Region | Status |
|---|---|---|---|
| ENERI | Buenos Aires | Argentina | Recruiting |
| Gold Coast University Hospital | Southport | Australia | Active Not Recruiting |
| Universitätsklinikum Christian Doppler Klinik Salzburg | Salzburg | Austria | Recruiting |
| Ziekenhuis Oost Limburg - Campus Sint-Jan | Genk | Belgium | Completed |
| Universitair Ziekenhuis Gent | Ghent | Belgium | Completed |
| Xuanwu Hospital Capital Medical University | Beijing | China | Completed |
| Chongqing University Three Gorges Hospital | Chongqing | China | Completed |
| First Affiliated Hospital of Jiamusi University | Jiamusi | China | Terminated |
| The Affiliated Hospital of Jinggangshan University | Ji’an | China | Completed |
| Kaifeng Central Hospital | Kaifeng | China | Terminated |
| Liaocheng People's Hospital | Liaocheng | China | Terminated |
| Lishui Municipal Central Hospital | Lishui | China | Terminated |
| The Second Affiliated Hospital of Nanchang University | Nanchang | China | Terminated |
| The Second Nanning Peoples Hospital | Nanning | China | Completed |
| Panzhihua Central Hospital | Panzhihua | China | Terminated |
| Qujing First Peoples Hospital | Qujing | China | Terminated |
| Yangpu District Central Hospital Shanghai Yangpu Hospital Tongji University | Shanghai | China | Completed |
| Shanxi Cardiovascular Hospital | Taiyuan | China | Completed |
| The First Affiliated Hospital Of Xi'an Jiaotong University | Xi'an | China | Completed |
| The First Peoples Hospital of Xianyang | Xianyang | China | Completed |
| Zhangzhou Municipal Hospital of Fujian Province | Zhangzhou | China | Completed |
| Zhuhai Peoples Hospital | Zhuhai | China | Terminated |
| Zhumadian Central Hospital | Zhumadian | China | Completed |
| Rigshospitalet | Copenhagen | Denmark | Recruiting |
| Turun Yliopistollinen keskussairaala | Turku | Finland | Recruiting |
| CHU Besancon - Hôpital Jean Minjoz | Besançon | France | Recruiting |
| CHU de Bordeaux - Centre Universitaire Pellegrin | Bordeaux | France | Completed |
| CHU Brest, Hôpital de la Cavale Blanche | Brest | France | Recruiting |
| Hôpital Pierre Wertheimer | Bron | France | Recruiting |
| CHU de Caen | Caen | France | Completed |
| Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied | Clermont-Ferrand | France | Completed |
| CHU Dijon Bourgogne | Dijon | France | Completed |
| AP-HP Hôpital Bicêtre | Le Kremlin-Bicêtre | France | Recruiting |
| CHU Limoges - Hôpital Dupuytren | Limoges | France | Recruiting |
| Hôpital de la Timone-CHU de Marseille | Marseille | France | Recruiting |
| CHU de Montpellier - Hôpital Gui de Chauliac | Montpellier | France | Recruiting |
| CHU de Nancy - Hôpital Central | Nancy | France | Terminated |
| CHU de Nantes Hôpital Laennec | Nantes | France | Active Not Recruiting |
| GHU Paris Psychiatrie & Neurosciences | Paris | France | Completed |
| Fondation Ophtalmologique Adolphe de Rothschild | Paris | France | Recruiting |
+ 59 more sites — see the full list on the official registry below.
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT02988128 on ClinicalTrials.gov ↗ ← All trials in South Korea