Clinical Trials Logo
  1. Home
  2. Aneurysm
  3. NCT05686733

Pre-SEAL™IT: Saccular Endovascular Aneurysm Lattice System First In Human Interventional Trial — Pre-SEAL™IT  

Aneurysm Clinical Trial

Official title:
Pre-SEAL™IT: Saccular Endovascular Aneurysm Lattice System First In Human Interventional Trial

Clinical Trial Summary

To establish the preliminary safety and effectiveness of the SEAL™ Endovascular Aneurysm Lattice System for the treatment of saccular intracranial aneurysms. The data from this study will be used to support: 1. EU CE Mark labelling 2. US FDA Investigational Device Exemption (IDE) approval support of PMA approval.

Clinical Trial Description

First In Human (FIH), prospective, single-arm, multicenter, interventional study. Patients presenting with evidence of a single unruptured or ruptured aneurysm requiring treatment will be enrolled into the study and treated using the SEAL™ System. Immediate post-procedure angiographic findings, clinical presentation, safety, and imaging follow-up for each subject will be collected at 24 hours, 3 (MRA), 6, 12 and 24-months post-procedure. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05686733
Study type Interventional
Source Galaxy Therapeutics INC
Contact
Status Completed
Phase N/A
Start date January 26, 2022
Completion date February 17, 2024
View Details
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06235619 - Arch Size Study for Anatomical Variations
Not yet recruiting NCT00905931 - Lycopene Following Aneurysmal Subarachnoid Haemorrhage Phase 2
Completed NCT01178710 - Effect of Simvastatin on Cardiac Function N/A
Completed NCT00349908 - A Feasibility Study of the Cordis Neurovascular Self Expanding Stent System in Intracranial Arteries Phase 1
Recruiting NCT03285100 - The Effects of Discontinuation of Vitamin K Antagonists on the Rate of Elastin Degradation N/A
Recruiting NCT06189950 - Registration Trial of the Intracranial Visualized Stent for the Wide-necked Intracranial Aneurysms:REBRIDGE N/A
Active, not recruiting NCT04592185 - The Study of the Fenestrated Anaconda Device in the Treatment of Abdominal Aortic Aneurysms
Completed NCT01970605 - Silver Graft All Comers Registry
Completed NCT00282893 - Balloon Prophylaxis of Aneurysmal Vasospasm Phase 2
Active, not recruiting NCT00549380 - Clinical Study of Aneurysm Exclusion Phase 1
Completed NCT04598802 - COvera in BRAnch Registry
Completed NCT04246125 - Patient Skin Dose in Interventional Radiology
Recruiting NCT05829746 - PROSPECTIVE, MULTI-CENTER, OPEN-LABEL, SINGLE-ARM REGISTRATION TRIAL OF THE TUBRIDGE FOR THE TREATMENT OF WIDE-NECKED SMALL AND MEDIUM-SIZED INTRACRANIAL ANEURYSMS N/A
Completed NCT03242343 - VasQ External Support for Arteriovenous Fistula N/A
Recruiting NCT02878967 - Standardized Long Term Follow-up of Patients After Endovascular Embolization of a Brain Aneurysm
Active, not recruiting NCT02345005 - Iliac Branch Excluder ReGistry (IceBERG)
Recruiting NCT02167997 - EffectiveNess and SAfety of Small ANeurysm COiling Trial N/A
Recruiting NCT00549016 - Clinical Study of Aneurysm Exclusion N/A
Completed NCT02848612 - Evaluation of the Amiens University Hospital Neuroradiology Anticoagulation Protocol
Enrolling by invitation NCT04269447 - Prospective Aortic Biobank of POP-STAR