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 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
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
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
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
Coronary Atherosclerosis, Myocardial Infarction
CANARY: Coronary Assessment by Near-infrared of Atherosclerotic Rupture-prone Yellow
The CANARY (Coronary Assessment by Near-infrared of Atherosclerotic Rupture-prone Yellow) Study is a pivotal trial to evaluate criteria for defining a Lipid Core Plaque (LCP) that is at high risk of rupturing during standard of…
- Conditions
- Coronary Atherosclerosis, Myocardial Infarction, Coronary Plaque Embolization
- Trial name
- CANARY (NCT01268319)
- Testing
- Embolic Protection Device (EPD), Intracoronary Spectroscopy and Ultrasonic Evaluation, Angioplasty and Stent Implant
- Where
- 9 sites in United States
- Volunteers
- 85 people
- Sponsor
- Infraredx
Carotid Artery Stenosis
GORE Embolic Protection With Reverse Flow
To compare the 30-day safety and efficacy of the GORE Flow Reversal System when used with approved carotid stents to an Objective Performance Criterion derived from distal embolic protection studies.
- Trial name
- EMPiRE (NCT00594100)
- Testing
- GORE Flow Reversal System (GFRS)
- Where
- 2 sites in United States
- Volunteers
- 245 people
- Sponsor
- W.L.Gore & Associates
Peripheral Embolization
EMBA Peripheral Embolization Device ("EPED") Study
This is an open label, acute, non-randomized, prospective, "first in man" (FIM) single-center study of the EMBA Medical Peripheral Embolization Device (PED).
- Trial name
- EPED (NCT02335788)
- Testing
- The EMBA Peripheral Embolization Device
- Where
- New Zealand
- Volunteers
- 15 people
- Sponsor
- EMBA Medical, Inc.
Brain Aneurysms
International Retrospective Study of Pipeline Embolization Device
The primary objective of this retrospective study is to determine the incidence of important safety outcomes in patients who have undergone Pipeline Embolization Device placement for intracranial aneurysms (IAs).
- Trial name
- IntrePED (NCT01558102)
- Where
- 17 sites in United States, Argentina and 4 more
- Volunteers
- 793 people
- Sponsor
- Medtronic Neurovascular Clinical Affairs
Intracranial Aneurysms
Feasibility Study of the LVIS™ (Low-profile Visualized Intraluminal Support)Device
The purpose of this study is to evaluate the safety and probable benefit of the Low-profile Visualized Intraluminal Support (LVIS™ and LVIS™ Jr.)devices from MicroVention, Inc.
- Trial name
- LVIS (NCT01541254)
- Testing
- Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)
- Where
- 6 sites in United States
- Volunteers
- 30 people
- Sponsor
- Microvention-Terumo, Inc.
Intracranial Aneurysm
Study to Evaluate the Safety and Effectiveness of the CODMAN ENTERPRISE® Vascular Reconstruction Device
The purpose of this study is to demonstrate effectiveness and safety of the CODMAN ENTERPRISE® Vascular Reconstruction Device and Delivery System.
- Trial name
- NCT02532517
- Testing
- CODMAN ENTERPRISE® Vascular Reconstruction Device and Delivery System
- Where
- 11 sites in United States
- Volunteers
- 45 people
- Sponsor
- Cerenovus, Part of DePuy Synthes Products, Inc.
Heart Failure
The AFteR Registry - Follow-up Study to Monitor the Efficacy and Safety of the Occlutech AFR in Heart Failure Patients
This study aims to monitor the safety and efficacy of Occlutech AFR device in patients with Heart Failure.
- Trial name
- AFR Registry (NCT04405583)
- Testing
- Occlutech Atrial Flow Regulator
- Where
- 36 sites in France, Germany and 6 more
- Volunteers
- 150 people
- Sponsor
- Occlutech International AB
Intracranial Aneurysm, Stroke, Ischemic
Neurovascular Product Surveillance Registry
Post market surveillance registry
- Trial name
- INSPIRE (NCT02988128)
- Testing
- Treatment for intracranial aneurysms, Treatment for Acute Ischemic Stroke
- Where
- 99 sites in Argentina, Australia and 22 more
- Volunteers
- 4,000 people
- Sponsor
- Medtronic Neurovascular Clinical Affairs
Intracranial Aneurysm
Prospective Study on Embolization of Intracranial Aneurysms With Pipeline™ Embolization Device
The purpose of this study is to assess the safety and effectiveness of the Pipeline™ device in the treatment of unruptured, wide-neck intracranial aneurysms.
- Trial name
- PREMIER (NCT02186561)
- Testing
- Pipeline™ Embolization Device/ Pipeline™Flex Embolization Device
- Where
- 23 sites in United States, Canada
- Volunteers
- 197 people
- Sponsor
- Medtronic Neurovascular Clinical Affairs