Clinical trials: Intracranial Aneurysm
Intracranial Aneurysm, Brain Arterial Disease
Safety, Performance and Usability of BALT Medical Devices: The EVIDENCE Post Marketing Clinical Follow-up Platform
BALT has designed an electronic platform to continue collecting clinical data as part of the post-marketing clinical follow-up of its devices.
- Conditions
- Intracranial Aneurysm, Brain Arterial Disease, Acute Ischemic Stroke, Peripheral Vascular Diseases
- Trial name
- EVIDENCE (NCT04927156)
- Testing
- BALT medical devices
- Where
- 12 sites in France, Germany and 1 more
- Volunteers
- 10,000 people
- Sponsor
- Balt Extrusion
Stroke
Evaluating Neuroprotection in Aneurysm Coiling Therapy
This is a randomized, double-blind, placebo-controlled, single-dose, design investigating the safety, tolerability and efficacy of NA-1, a peptide designed to reduce ischemic brain damage.
- Trial name
- ENACT (NCT00728182)
- Testing
- NA-1
- Where
- 14 sites in United States, Canada
- Volunteers
- 185 people
- Sponsor
- NoNO Inc.
Brain Aneurysm
CLinical EValuation of WEB 0.017 Device in Intracranial AneuRysms
The study is an observational, European, multi-center, prospective assessment of the clinical utility of the 0.017 WEB Aneurysm Embolization System in subjects with intracranial aneurysms deemed appropriate for endovascular…
- Trial name
- CLEVER (NCT03844334)
- Testing
- WEB Aneurysm Embolization System
- Where
- 4 sites in France, Germany and 1 more
- Volunteers
- 163 people
- Sponsor
- Microvention-Terumo, Inc.
Intracranial Aneurysm
MicroVention, Inc. Flow Re-Direction Endoluminal Device X (FRED™ X™) Post-Approval Study
The objective of this study is to generate contemporaneous clinical data to facilitate a reasonable comparison of the performance of the FRED™ X™ device with the performance of the FRED™ device.
- Trial name
- NCT05409989
- Testing
- FRED™ X™
- Where
- 23 sites in United States
- Volunteers
- 154 people
- Sponsor
- Microvention-Terumo, Inc.
Intracranial Aneurysm
Assessment of the Embolization of Neurovascular Lesions Using the Penumbra Smart Coil
The primary objective of this study is to gather post market data on the Penumbra SMART COIL® System (Smart System) in the treatment of intracranial aneurysms and other malformations.
- Trial name
- SMART (NCT02729740)
- Testing
- Penumbra Smart Coil, Penumbra Coil 400TM (PC400), Penumbra Occlusion DeviceTM(POD)
- Where
- 72 sites in United States, Canada
- Volunteers
- 995 people
- Sponsor
- Penumbra Inc.
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
Intracranial Aneurysms
Pivotal Study of the FRED Stent System in the Treatment of Intracranial Aneurysms
The purpose of this study is to evaluate the safety and effectiveness of the MicroVention Flow Redirection Intraluminal Device (FRED) system when used in the treatment of wide-necked intracranial aneurysms.
- Trial name
- FRED (NCT01801007)
- Testing
- Flow Re-Direction Endoluminal Device (FRED)
- Where
- 24 sites in United States, Japan
- Volunteers
- 145 people
- Sponsor
- Microvention-Terumo, Inc.
Intracranial Aneurysm
Success in Comaneci-assist Coils Embolization Surveillance Study (SUCCESS)
The Comaneci Embolization Assist Device is indicated for use in the neurovasculature as a temporary endovascular device used to assist in the coil embolization of wide-necked intracranial aneurysms with a neck width ≤ 10 mm.
- Trial name
- NCT04518670
- Testing
- Comaneci Embolization Assist Device
- Where
- 8 sites in United States
- Volunteers
- 90 people
- Sponsor
- Rapid Medical
Intracranial, Wide-Neck, Saccular Aneurysms
Study of the Enterprise Self-Expanding Stent System With Endovascular Coil Embolization of Wide- Neck Saccular Intracranial Artery Aneurysms
Cordis Self Expanding Stent for use with embolic coils for the treatment of wide-neck, intracranial, saccular aneurysms arising from a parent vessel
- Trial name
- NCT00233753
- Testing
- Cordis Neurovascular Self-Expanding Stent
- Volunteers
- 30 people
- Sponsor
- Codman & Shurtleff
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
Ruptured Cerebral Aneurysm, Ruptured Berry Aneurysm
Safety and Tolerability Study of EG-1962 in Aneurysmal Subarachnoid Hemorrhage
Phase 1/2a Multicenter, Controlled, Randomized, Open Label, Dose Escalation, Safety, Tolerability, and Pharmacokinetic Study Comparing EG-1962 and Nimodipine in Patients with Aneurysmal Subarachnoid Hemorrhage
- Trial name
- NEWTON (NCT01893190)
- Testing
- Nimodipine, Nimodipine Microparticles
- Where
- 23 sites in United States, Canada and 2 more
- Volunteers
- 73 people
- Sponsor
- Edge Therapeutics Inc
Intracranial Aneurysms
Adjunctive Neurovascular Support for Wide-neck Aneurysm Embolization and Reconstruction
This study is designed to evaluate the safety of the PulseRider in patients undergoing treatment for bifurcation basilar or carotid terminus aneurysms.
- Trial name
- ANSWER (NCT02312856)
- Testing
- PulseRider
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Pulsar Vascular
Intracranial Aneurysms
Canadian eCLIPs™ Safety and Feasibility Study Protocol
The purpose of this study is to evaluate the safety and feasibility of the eCLIPs™ Family of Products for the treatment of unruptured intracranial bifurcation aneurysms in conjunction with embolization coils.
- Trial name
- CESIS (NCT01957683)
- Testing
- eCLIPs™ Family of Products
- Where
- 5 sites in Canada
- Sponsor
- Evasc Medical Systems Corp.
Intracranial Aneurysm
Diversion-p64 Post Market Clinical Follow-Up Study to Assess Safety and Effectiveness of the p64 Flow Modulation Device
The purpose of this study is to assess safety and effectiveness of the p64 Flow Modulation Device.
- Trial name
- NCT02600364
- Where
- 26 sites in Argentina, Belgium and 8 more
- Volunteers
- 450 people
- Sponsor
- Phenox GmbH
Intracranial Aneurysm
pCONus Treatment of Wide Neck Intracranial Aneurysms
To assess safety and efficacy of pCONus for the treatment of wide neck bifurcation aneurysms.
- Trial name
- pToWin (NCT02554708)
- Testing
- implantation of the pCONus Bifurcation Aneurysm Implant
- Where
- 10 sites in Argentina, Austria and 3 more
- Volunteers
- 116 people
- Sponsor
- Phenox GmbH
Intracranial Aneurysms
Pivotal Study of the LVIS (Low Profile Visualized Intraluminal Support)
The purpose of this study is to evaluate the safety and efficacy of the Low Profile Visualized Intraluminal Support(LVIS™ and LVIS™ Jr.)devices from MicroVention, Inc.
- Trial name
- LVIS (NCT01793792)
- Testing
- LVIS™ and LVIS™ Jr
- Where
- 21 sites in United States
- Volunteers
- 153 people
- Sponsor
- Microvention-Terumo, Inc.
Intracranial Saccular Aneurysm, Either Rupture or Unruptured, Wide Neck Aneurysm
Solitaire Aneurysm Remodeling Registry
The objective of the registry is to evaluate the effectiveness and performance of the Solitaire Neurovascular Remodeling Device when used with embolic coils in the treatment of intracranial aneurysms.
- Trial name
- NCT04905303
- Where
- France
- 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.
Aneurysm, Intracranial
An EFS Assessing the Electrolytic eCLIPs System for Treatment of Intracranial Aneurysms
The purpose of this study is to investigate the feasibility and initial clinical safety of eCLIPs device use for the treatment of wide-necked bifurcation aneurysms.
- Trial name
- NCT04886505
- Testing
- Electrolytic eCLIPs Bifurcation System
- Sponsor
- Evasc Medical Systems Corp.
Intracranial Aneurysm
FRED Retrospective Study of Intracranial Aneurysms Treatment
To evaluate the long-term safety and efficacy of Flow Re-Direction Endoluminal Device System (FRED) in the treatment of intracranial aneurysms in the post-market environment
- Trial name
- FRED (NCT06982781)
- Testing
- Flow Re-Direction Endoluminal Device System(FRED)
- Volunteers
- 2,000 people
- Sponsor
- Microvention-Terumo, Inc.