Clinical trials: Vascular Aneurysm
Intracranial Aneurysms
Post-Market Product Surveillance of Intracranial ANeurysms Treated With Commercial ReGistered ACANDIS Devices in FrancE
The aims of this clinical data collection are to investigate mortality, morbidity and neurological outcome 12 months after treatment of subject's intracranial aneurysm(s) and additionally to evaluate potential residual risks…
- Trial name
- ANCRAGE PMS (NCT06940934)
- Where
- France
- Volunteers
- 100 people
- Sponsor
- Acandis GmbH
Intracranial Aneurysms
Safety and Efficacy Analysis of FRED® Embolic Device in Aneurysm Treatment
A prospective, multicenter, observational evaluation of the safety and efficacy of the FRED® device in the treatment of intracranial aneurysms.
- Trial name
- SAFE (NCT02921698)
- Testing
- FRED®
- Volunteers
- 100 people
- Sponsor
- Microvention-Terumo, Inc.
Unruptured Intracranial Aneurysm
Assessment of the Clinical and Economic Impact of Sim&Size, a Simulation Software for Implantable Devices Used in the Treatment of Intracranial Aneurysms: A Prospective Multicenter Study.
In recent years, endovascular treatment of intracranial aneurysms has seen remarkable growth, now surpassing traditional surgical approaches in terms of frequency of use.
- Trial name
- ESSNAI (NCT07433075)
- Testing
- 3D simulation of placement of neurovascular implantable medical device, Manual planning of endovascular procedure
- Where
- 6 sites in France
- Volunteers
- 576 people
- Sponsor
- Sim&Cure
Aneurysmal Subarachnoid Hemorrhage
A Safety and Efficacy Study of NicaPlant® in Aneurysmal Subarachnoid Haemorrhage Patients Undergoing Aneurysm Clipping
This study of NicaPlant® is conducted in patients who have a subarachnoid haemorrhage. Patients will be randomized in two treatment groups.
- Trial name
- NCT04269408
- Testing
- Nicardipine, Standard of care
- Where
- 6 sites in Austria, Germany
- Volunteers
- 41 people
- Sponsor
- BIT Pharma GmbH
Intracranial Aneurysm
PARAT PLUS (The Tubridge Plus For The Treatment Of Wide-Necked Intracranial Aneurysms)
A trial to evaluate the safety and efficacy of the Tubridge Plus flow-diverter stent for the treatment of intracranial wide-necked aneurysms.
- Trial name
- NCT05898893
- Testing
- Microport NeuroTech Tubridge Plus flow-diverter Stent
- Where
- 8 sites in China
- Volunteers
- 99 people
- Sponsor
- MicroPort NeuroTech Co., Ltd.
Subarachnoid Hemorrhage, Ruptured Intracranial Aneurysm
Safety and Efficacy Study of a Single Dose of NA-1 in Patients Undergoing Endovascular Repair of Ruptured Aneurysms
This is a randomized, double-blind, placebo-controlled, single-dose study investigating the safety and efficacy of NA-1 in patients with subarachnoid hemorrhage (SAH) undergoing endovascular repair of ruptured intracranial…
- Trial name
- ENACT-2 (NCT02056574)
- Testing
- NA-1
- Where
- 12 sites in United States, Canada
- Sponsor
- NoNO Inc.
Abdominal Aortic Aneurysms
A Multicenter, Open Label, Prospective, Non-Randomized Study Of INCRAFT™ In Subjects With AAA (INNOVATION)
This study is a multi-center prospective, open label, non-randomized investigation of INCRAFT™ in subjects with abdominal aortic aneurysms. The study will enroll up to 60 subjects in up to 7 sites in Germany and Italy.
- Trial name
- INNOVATION (NCT01106391)
- Testing
- Cordis AAA stent graft system "INCRAFT TM"
- Where
- Germany
- Volunteers
- 60 people
- Sponsor
- Cordis US Corp.
Aneurysms
A Study to Look at Performance of MICRUSFRAME and GALAXY Coils for the Treatment of Intracranial Aneurysms
A post-market registry evaluating ruptured/unruptured aneurysms treated with MICRUSFRAME and GALAXY coils
- Trial name
- STERLING (NCT03642639)
- Testing
- MICRUSFRAME and GALAXY coils
- Where
- 51 sites in United States, Belgium and 8 more
- Volunteers
- 723 people
- Sponsor
- Cerenovus, Part of DePuy Synthes Products, Inc.
Aneurysm, Arteriovenous Malformations
Post Market Clinical Follow-Up for ED Coil / Electro-detach Generator v4
This is a multicenter post-marketing clinical follow-up study to collect safety and performance data in a prospective cohort of patients who will have undergone coil embolization using the ED Coil and ED Detach Generator v4.
- Conditions
- Aneurysm, Arteriovenous Malformations, Arterio-venous Fistula
- Trial name
- NCT03853070
- Testing
- ED Coil / Electro-detach Generator v4
- Where
- 3 sites in Belgium, Germany
- Volunteers
- 100 people
- Sponsor
- Kaneka Corporation
Intracranial Aneurysm
Safety and Performance of the Neuroform Atlas™ Stent System
The objective of this retrospective study is to describe in real-life settings the clinical practice, utilization and the treated population outcomes at 1-year (12-16 months) follow-up at selected, representative centers in…
- Trial name
- ATLAS-FR (NCT04162483)
- Testing
- Neuroform Atlas Stent System
- Where
- France
- Volunteers
- 310 people
- Sponsor
- Stryker Neurovascular
Juxtarenal Aortic Aneurysm, Pararenal Aortic Aneurysm
Pilot Study of the Endologix Fenestrated Stent Graft System
The purpose of this study is to determine whether the Endologix fenestrated stent graft system is safe and feasible in the endovascular repair of juxtarenal or pararenal aortic aneurysm.
- Trial name
- NCT01437215
- Testing
- Ventana Fenestrated Stent Graft System
- Where
- 2 sites in Chile, New Zealand
- Volunteers
- 15 people
- Sponsor
- Endologix
Cancer, Metabolic Disease
An Observational Study On TheAccuracy Of Whole-Body Magnetic Resonance Imaging (Wb-Mri) ScreeningTo Predict Clinically Significant Diagnoses In General Population Subjects Interested In Proactive And Advanced General Preventive Healthcare.
This is a prospective, single-arm, observational study capturing data from whole-body magnetic resonance imagining (WB-MRI) from up to 100,000 male and female subjects 18 years of age or older recruited at multiple clinical sites…
- Conditions
- Cancer, Metabolic Disease, Aneurysm, Neurologic Disorder
- Trial name
- Hercules (NCT06212479)
- Testing
- MRI Scan
- Where
- United States
- Volunteers
- 100,000 people, healthy volunteers welcome
- Sponsor
- Hercules
Aortic Aneurysm, Aortic Aneurysm Abdominal
AI-CARE: Artificial Intelligence for Cardiovascular Analysis and Risk Evaluation
This study will test how well an artificial intelligence (AI) software called Aorta AIM measures the size of the aorta (the body's main blood vessel) from CT scans.
- Conditions
- Aortic Aneurysm, Aortic Aneurysm Abdominal, Aortic Aneurysm and Dissection, Aortic Aneurysm, Thoracoabdominal
- Trial name
- AI-CARE (NCT07438327)
- Testing
- Aorta AIM Automated Measurement, Expert Radiologist Manual Measurement
- Where
- 3 sites in United States, Brazil
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Aiatella Oy
Aortic Aneurysm, Thoracic
Evaluation of the GORE TAG Thoracic Endoprosthesis in the Treatment of Aneurysms
The purpose of this post-approval study is to evaluate the long-term performance of the GORE TAG® Thoracic Endoprosthesis (TAG device) in the primary treatment of descending thoracic aortic (DTA) aneurysms
- Trial name
- NCT00590759
- Testing
- GORE TAG® Thoracic Endoprosthesis
- Where
- 25 sites in United States
- Volunteers
- 150 people
- Sponsor
- W.L.Gore & Associates
Cardiovascular Diseases, Abdominal Aortic Aneurysm
A Clinical Study to Evaluate the Safety and Performance of the Modular AAA Stent-Graft System
This is a prospective multicenter observational study with 20 patients to evaluate the performance of SCITECH stent for treatment of AAA.
- Trial name
- Stent-Graft (NCT01368679)
- Testing
- Endoprothesis Implantation
- Where
- 2 sites in Brazil
- Sponsor
- Scitech Produtos Medicos SA
Aneurysm Cerebral, Bifurcation
LUMENS-1 Canada Early Feasibility Study Clinical Investigation Plan
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
- NCT07259018
- Testing
- LuSeed Aneurysm Embolization System
- Where
- Canada
- Volunteers
- 10 people
- Sponsor
- LuSeed Vascular LTD.
Vasospasm
Comparing the Nautilus NeuroWaveTM to TCD or DSA for the Detection of Vasospasm
To determine the efficacy of using the Jan Medical NNW system as a diagnostic aid in detection of moderate and severe vasospasm for detection of vasospasm in patients with subarachnoid hemorrhage.
- Trial name
- NCT02071875
- Testing
- Nautilus NeuroWaveTM recording
- Where
- Germany
- Volunteers
- 43 people
- Sponsor
- Jan Medical, Inc.
Aortic Aneurysm
Radiation Free Study
This is a prospective, randomized, unblinded, multi-center study. Sites were selected from different geographies (EU and US) with different clinical practice to ensure the results are more generalizable.
- Trial name
- RadFree (NCT06549348)
- Testing
- Measure average procedure fluoroscopy time using LumiGuide and conventional fluoroscopy guidance
- Where
- 11 sites in United States, Belgium and 4 more
- Volunteers
- 182 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Aneurysm, Endoleak
Cera™ Vascular Plug System Post-Market Clinical Follow-Up
The objective of the study is to collect and evaluate clinical data on patients of the Lifetech Cera™ Vascular Plug System to: confirm the performance confirm the safety identify previously unknown side-effects monitor the…
- Conditions
- Aneurysm, Endoleak, Pulmonary Arteriovenous Malformation, Portal Hypertension
- Trial name
- NCT06099015
- Testing
- Cera™ Vascular Plug System
- Where
- 9 sites in Germany, Italy and 1 more
- Volunteers
- 132 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
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