Clinical trials: Device Embolisation
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
Pulmonary Arteriovenous Malformations
Efficacy & Safety of LOBO™ Vascular Occlusion Device for Embolization of Pulmonary Arteriovenous Malformations
The goal of this clinical trial is to evaluate both the technical success and efficacy of using the LOBO™ device in patients undergoing embolization of Pulmonary Arteriovenous Malformations (PAVM).
- Trial name
- PAVM (NCT06735976)
- Testing
- PAVM Embolization, PAVM Embolization with a LOBO™ device
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- University of North Carolina, Chapel Hill
Self Efficacy, Medical Device Complication
Chinese Registry of Assisted Embolization for Unruptured Wide Necked Intracranial Aneurysm Using LVIS Stent
This study aims to investigating the efficacy and safety of low profile visualized intraluminal support (LVIS) stents for the treatment of unruptured intracranial saccular aneurysms.
- Trial name
- CRANIAL-1 (NCT02830373)
- Testing
- LVIS stents
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Changhai Hospital
Self Efficacy, Medical Device Complication
Chinese Registry of Assisted Embolization for Ruptured Wide Necked Intracranial Aneurysm Using LVIS Stent
This study aims to investigating the efficacy and safety of low profile visualized intraluminal support (LVIS) stents for the treatment of ruptured intracranial saccular aneurysms. The follow-up duration is 1 year.
- Trial name
- CRANIAL-2 (NCT02830386)
- Testing
- LVIS stent
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Changhai Hospital
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.
Aneurysm
Enterprise 2 Vascular Reconstruction Device
The primary objective of this study is to collect data regarding the effectiveness of using the Enterprise 2 Reconstruction Device in successfully embolizing intracranial aneurysms with wide neck configuration.
- Trial name
- NCT05254067
- Testing
- Codman Enterprise 2 Vascular Reconstruction Device
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Methodist Health System
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
Adenomyosis
Intrauterine Device Versus Uterine Artery Embolization for Adenomyosis
The primary purpose of this study is to compare the therapeutic efficacy of intrauterine device and uterine artery embolization for uterine adenomyosis.
- Trial name
- NCT06043583
- Testing
- Intrauterine device, Uterine artery embolization
- Where
- South Korea
- Volunteers
- 56 people
- Sponsor
- Yonsei University
Intracranial Aneurysm, Flow Diverter
DERIVO® 2heal® Study: Clinical Safety and Efficacy of the DERIVO® 2heal® Embolisation Device
To analyse the clinical safety and efficacy of the DERIVO® 2heal® Embolisation Device in the standard clinical routine of flow diversion treatment with respect to the mid- and long-term clinical and angiographic outcomes.
- Trial name
- REheal (NCT05543447)
- Testing
- Flow Diverter Treatment with DERIVO 2 Heal Embolisation Device
- Where
- 17 sites in Germany
- Volunteers
- 158 people
- Sponsor
- Acandis GmbH
Intracranial Aneurysm
Nomogram for Predicting In-stent Stenosis After Pipeline Embolization Device Treatment in Patients With Intracranial Aneurysm
Intracranial aneurysms (IAs) are the primary cause of non-traumatic subarachnoid hemorrhage with high morbidity and mortality. Flow diverters, such as pipeline embolization devices (PEDs), are among the most effective methods for…
- Trial name
- PED-ISS (NCT06715930)
- Testing
- Interventional treatment
- Where
- China
- Volunteers
- 1,500 people
- Sponsor
- Beijing Tiantan Hospital
Aneurysm Cerebral, Bifurcation
LUMENS-1 EU EFS CIP
The primary objective of this clinical investigation is to evaluate the early safety and feasibility of the LuSeed Aneurysm Embolization System for treating unruptured intracranial aneurysms (IA).
- Conditions
- Aneurysm Cerebral, Bifurcation, Unruptured Intracranial Aneurysm, Saccular Aneurysm
- Trial name
- NCT06761365
- Testing
- LuSeed Aneurysm Embolization System
- Where
- 6 sites in Bulgaria, Germany and 2 more
- Volunteers
- 30 people
- Sponsor
- LuSeed Vascular LTD.
Pelvic Congestion Syndrome, Pelvic Varicose Veins
Pelvic Varicose Veins Treated With Vascular Plugs Type Amplatzer: REPiVAC
Spanish multicentric record to study the efficacy and safety of the treatment with plugs in Pelvic Congestion Syndrome.
- Conditions
- Pelvic Congestion Syndrome, Pelvic Varicose Veins, Follow-up Study, Embolization, Therapeutic
- Trial name
- REPiVAC (NCT04115137)
- Testing
- pelvic varicose veins plug embolization
- Where
- 2 sites in Spain
- Volunteers
- 300 people
- Sponsor
- Group of Research in Minimally Invasive Techniques
Intracranial Aneurysm, Ruptured Aneurysm
EvaLuate EndoVascular Treatment of Acutely Ruptured Shallow Intradural Aneurysms With the Pipeline™ Flex Embolization Device With Shield TEchnology™ (ELEVATE)
The purpose of the study is to assess the safety and effectiveness of the Pipeline™ Flex Embolization Device with Shield Technology™ in the treatment with acutely ruptured intracranial aneurysms.
- Trial name
- ELEVATE (NCT04391803)
- Testing
- Pipeline™ Flex Embolization Device with Shield Technology™
- Where
- 7 sites in United States
- Volunteers
- 25 people
- Sponsor
- Medtronic Neurovascular Clinical Affairs
Intracranial Aneurysm
MAXimizing Flow Diversion Effect On the Treatment of Large Intracranial Aneurysms With Embolization Devices
Investigate the ability of the intra-operative, intra-aneurysmal flow evaluation to assist with the treatment of intracranial large aneurysms using Embolization Device(s)
- Trial name
- MAX-PIPE (NCT03161769)
- Testing
- Neurovascular treatment of intracranial aneurysms, AneurysmFlow image processing software
- Where
- Canada
- Volunteers
- 30 people
- Sponsor
- University Health Network, Toronto