Clinical trials: Device Embolisation
Intracranial Aneurysm
Safety & Performance of the World Medica World Diverter Embolization Device
The objective of this study is to investgiate the safety and clinical performance of the World Diverter Emoblization Device for the endovascular treatment of wide-neck (neck width ≥ 4 mm or dome-to-neck ratio <2) or fusiform…
- Trial name
- NCT07339358
- Testing
- Flow diverter implantation
- Where
- Spain
- Volunteers
- 72 people
- Sponsor
- World Medica USA, LLC
Intracranial Aneurysm, Pipeline Embolization Device
Post Market Multi-Center Retrospective Research on Embolization of Intracranial Aneurysms With Pipeline Embolization Device in China
Pipeline TM embolization device launched to China in 2014, and has been widely used to treat large width IA. Therefore, it is necessary to collect and analysis the clinical data to evaluate effectiveness and safety of its usage…
- Trial name
- PLUS (NCT03831672)
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Beijing Neurosurgical Institute
Intracranial Aneurysms
Evaluation of a Novel Intrasaccular Embolization Device for the Treatment of Intracranial Aneurysms
The study is a prospective, multicenter single-arm cohort. The purpose of this study is to evaluate efficacy and safety of a novel intrasaccular embolization device for the treatment of intracranial aneurysms.
- Trial name
- NCT07022249
- Testing
- Intrasaccular Embolization Device
- Volunteers
- 150 people
- Sponsor
- Ton-Bridge Medical Tech. Co., Ltd
Intracranial Aneurysm
Pipeline™ Vantage Embolization Device With Shield Technology™ for Wide-Necked Intracranial Aneurysms (ADVANCE)
The purpose of this study is to assess the safety and effectiveness of the Pipeline™ Vantage Embolization Device with Shield Technology™ in the treatment of intracranial aneurysms within the intended indication for use.
- Trial name
- ADVANCE (NCT03873714)
- Testing
- Pipeline™ Vantage Embolization Device with Shield Technology™
- Where
- 3 sites in United States
- Volunteers
- 14 people
- Sponsor
- Medtronic Neurovascular Clinical Affairs
Left Atrial Appendage Occluder, Device Embolisation
Therapy Strategies After LAA Occluder Device Embolization
The investigators thought to evaluate risk factors, therapeutic approaches and outcomes after left atrial appendage occluder device embolization (LAAO, either surgical or interventional).
- Conditions
- Left Atrial Appendage Occluder, Device Embolisation, Therapy Strategies, Risk Factors
- Trial name
- LAAODE (NCT05014477)
- Testing
- Removal or leaving of LAA occluders
- Where
- Germany
- Volunteers
- 400 people
- Sponsor
- Cardiovascular Center Frankfurt
Cerebral Embolization During TAVI Using Balloon-expandable vs. Self-expandable Valves
PROTECT TAVI - Prospective Randomized Outcome Study in TAVI Patients Undergoing Periprocedural Embolic Cerebral Protection With the Sentinel™ Device
This prospective, randomized study was designed to analyse the difference of cerebral embolization in patients undergoing transcatheter aortic valve implantation with balloon-expandable vs.
- Trial name
- PROTECT (NCT02895737)
- Testing
- TAVI: Edwards SAPIEN 3, Edwards Lifesciences, Edwards Sapien Ultra, TAVI: Edwards SAPIEN 3, Edwards Lifesciences, Edwards Sapien Ultra; Sentinel™ Cerebral Protection Systems, TAVI: CoreValve® Evolut R™, CoreValve Medtronic
- Where
- Germany
- Volunteers
- 328 people
- Sponsor
- Deutsches Herzzentrum Muenchen
Intracranial Aneurysm, Cerebral Aneurysm
Safety and Clinical Effectiveness of Pipeline™ Shield Devices for Intracranial Aneurysms
This observational, retrospective, single-arm, multi-centre cohort study will use real-world data (RWD) to develop real-world evidence (RWE) of the safety and clinical effectiveness of the Pipeline™ Flex Embolization Device with…
- Conditions
- Intracranial Aneurysm, Cerebral Aneurysm, Subarachnoid Hemorrhage, Stroke, Acute
- Trial name
- SCOPE-AUS (NCT03815149)
- Testing
- Pipeline™ Flex Embolization Device with Shield Technology™
- Where
- 4 sites in Australia
- Volunteers
- 500 people
- Sponsor
- Gold Coast Hospital and Health Service
Aneurysm, Intracranial Aneurysm
Trenza Embolization Device for Intrasaccular Aneurysm Treatment
The purpose of this Post-Market Clinical Follow-up study is to assess the safety and performance of the Trenza in the treatment of intracranial aneurysms.
- Trial name
- NCT04380350
- Where
- 18 sites in Austria, Finland and 5 more
- Volunteers
- 150 people
- Sponsor
- Stryker Neurovascular
Intracranial Aneurysm
Intelligent Microcatheter Shaping for Intracranial Aneurysm Coil Embolization
This prospective, multicenter, observational registry study will evaluate the real-world safety, effectiveness, and clinical value of artificial intelligence (AI)-assisted microcatheter shaping during coil embolization of…
- Trial name
- NCT07749404
- Testing
- Physician-Experience Microcatheter Shaping, AI-Assisted Microcatheter Shaping Simulation Technology
- Where
- China
- Volunteers
- 1,438 people
- Sponsor
- Xuanwu Hospital, Beijing
Intracranial Aneurysm, Brain Aneurysm
The RISE Trial: A Randomized Trial on Intra-Saccular Endobridge Devices
Intracranial bifurcation aneurysms are commonly repaired with surgical and with endovascular techniques. Wide-necked bifurcation aneurysms (WNBA) are a difficult subset of aneurysms to successfully repair endovascularly, and a…
- Conditions
- Intracranial Aneurysm, Brain Aneurysm, Unruptured Cerebral Aneurysm, Ruptured Cerebral Aneurysm
- Trial name
- RISE (NCT03936647)
- Testing
- surgical clipping, simple coiling, high-porosity stenting with/ without coiling, intra-arterial flow diversion with/ without coiling, WEB embolization device
- Where
- 4 sites in Canada
- Volunteers
- 250 people
- Sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
Intracranial Aneurysm
Real-World Study of Woven EndoBridge for Intracranial Aneurysm Treatment
We designed the Real-World Study of Woven EndoBridge for Intracranial Aneurysm Treatment (WEB-RWS), an ambidirectional, multicenter, post-market real-world study with a prospective active surveillance component.
- Trial name
- WEB-RWS (NCT07620626)
- Testing
- Intrasaccular Flow Disruption Device
- Where
- China
- Volunteers
- 1,000 people
- Sponsor
- Xuanwu Hospital, Beijing
Unruptured Wide-neck Aneurysms
Citadel Embolization Device Study
The purpose of this study is to gather safety and effectiveness data on Stryker Neurovascular's Next Generation Target Detachable Coil (hereafter referred to as the Citadel Embolization Device), when used with Target Detachable…
- Trial name
- NCT04057352
- Testing
- Citadel Embolization Device
- Where
- 25 sites in United States
- Volunteers
- 150 people
- Sponsor
- Stryker Neurovascular
Carotid Stenosis, Constriction, Pathologic
GORE Flow Reversal System and GORE Embolic Filter Extension Study
The objective of this study is to provide an ongoing evaluation of clinical outcomes associated with the GORE Flow Reversal System and the GORE Embolic Filter when used for embolic protection during carotid artery stenting.
- Conditions
- Carotid Stenosis, Constriction, Pathologic, Carotid Artery Diseases, Cerebrovascular Disorders
- Trial name
- FREEDOM (NCT01343667)
- Testing
- Gore Flow Reversal System, Gore Embolic Filter
- Where
- 39 sites in United States
- Volunteers
- 1,397 people
- Sponsor
- W.L.Gore & Associates
Intracranial Aneurysm
Safety and Effectiveness of ENTERPRISE 2 Device in the Endovascular Treatment of Intracranial Aneurysms
The study is designed to evaluate the safety and effectiveness of ENTERPRISE 2 vascular reconstruction device and delivery system (hereinafter referred to as ENTERPRISE 2) to facilitate endovascular coil embolization of…
- Trial name
- EMPOWER (NCT04289480)
- Testing
- ENTERPRISE 2 device
- Where
- 10 sites in China
- Volunteers
- 164 people
- Sponsor
- Medos International SARL
Embolization, Therapeutic
Caterpillar™ Arterial Embolization Device Post-Market Study
The primary objective of this study is to evaluate the performance and safety of the Caterpillar™ Arterial Embolization Device when used for arterial embolization in the peripheral vasculature in a real world, on-label…
- Trial name
- MONARCH (NCT04244370)
- Testing
- Caterpillar™ Arterial Embolization Device
- Where
- 11 sites in United States
- Volunteers
- 50 people
- Sponsor
- C. R. Bard
Unruptured Wide-neck Intracranial Aneurysms
A Study Evaluating the Safety and Effectiveness of the PulseRider® Aneurysm Neck Reconstruction Device Used in Conjunction With Endovascular Coil Embolization in the Treatment of Wide-Neck Bifurcation Intracranial Aneurysm
This is a prospective, multi-center, non-randomized clinical evaluation utilizing the PulseRider® Aneurysm Neck Reconstruction Device.
- Trial name
- NAPA (NCT03383666)
- Testing
- PulseRider® Aneurysm Neck Reconstruction Device
- Where
- 2 sites in United States
- Volunteers
- 21 people
- Sponsor
- Pulsar Vascular
Intracranial Aneurysm
Prospective, Post-registration, Interventional, Randomized, in Parallel Groups, Multicenter Eurasian Clinical Study of DERIVO®/DERIVO® Mini Aneurysm Embolization Device, Europe-Asia
Prospective, post-registration, interventional, randomized, in parallel groups, multicenter Eurasian clinical study of DERIVO®/DERIVO® mini Aneurysm Embolization Device, Europe-Asia
- Trial name
- NCT06400940
- Testing
- ticagrelor (tablets, 180 mg) or prasugrel (tablets, 10 mg)., combination of clopidogrel (tablets, 75 mg) and acetylsalicylic acid (ASA, tablets, 100 mg) or a combination of ticagrelor (tablets, 180 mg) and ASA (tablets, 100 mg).
- Where
- Russia
- Volunteers
- 640 people
- Sponsor
- Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Treatment
Pipeline Embolization Device for the Treatment of Intracranial Aneurysms on the Long Term Safety and Efficacy
Since its launch in China in 2014, Pipeline Embolization Device (PED) has been widely used in the treatment of intracranial aneurysms.
- Trial name
- NCT06456697
- Where
- China
- Volunteers
- 482 people
- Sponsor
- Xuanwu Hospital, Beijing
Aneurysm
Pipeline™ Flex Embolization Device With Shield Technology™ Clinical Study
The objective of the study is to assess the incidence of safety outcomes in patients treated with Pipeline™ Flex embolization device with Shield Technology™.
- Trial name
- PFLEX (NCT02390037)
- Where
- 7 sites in Belgium, Germany and 4 more
- Volunteers
- 50 people
- Sponsor
- Medtronic Neurovascular Clinical Affairs
Intracranial Aneurysm
INSPIRE Pipeline™ Shield Post Approval Study
The purpose of the Pipeline™ Flex Embolization Device with Shield Technology™ Post Approval Study (PAS) ("Pipeline™ Shield PAS") is to collect on-label use data in patients undergoing treatment for intracranial aneurysms (IA)…
- Trial name
- NCT05071963
- Testing
- Treatment of Intracranial Aneurysms
- Where
- 16 sites in United States
- Volunteers
- 246 people
- Sponsor
- Medtronic Neurovascular Clinical Affairs