INSPIRE Pipeline™ Shield Post Approval Study

Status Recruiting

Clinical Trial Summary

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) using the Pipeline™ Flex Embolization Device with Shield Technology™ ("Pipeline™ Shield Device") in a real-world post approval setting within the United States.

Clinical Trial Description

The INSPIRE Pipeline™ Shield Post Approval Study is an observational, prospective, multi-center, single-arm registry to collect on-label use data in patients undergoing treatment for intracranial aneurysms using the Pipeline™ Flex Embolization Device with Shield Technology™ according to the intended use. The primary objective of this study is to evaluate the on-label use of the Pipeline™ Shield Device in patients undergoing treatment for intracranial aneurysms per institutional routine clinical care in a real-world post approval study setting in the U.S. This study is conducted under the Product Surveillance Registry (NCT01524276) and is a sub-study to the therapy specific Neurovascular Product Surveillance Registry (NCT02988128). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05071963
Study type	Observational [Patient Registry]
Source	Medtronic Neurovascular Clinical Affairs
Contact	Medtronic Neurovascular Clinical Affairs
Phone	949-837-3700
Email	rs.shieldpostapproval@medtronic.com
Status	Recruiting
Phase
Start date	December 20, 2021
Completion date	March 2027

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04870047` - Coating to Optimize Aneurysm Treatment In The New Flow Diverter Generation	N/A
Recruiting	`NCT05968053` - Detection of Microplastics and Nanoplastics in Neurosurgery Patients (DT-MiNi)
Not yet recruiting	`NCT05665309` - Interest of Pre-operative Use of 3D Printing for Endovascular Treatment of Unruptured Intracranial Aneurysms With Intrasaccular Flow Disruptor	N/A
Completed	`NCT02783339` - Neuroform Atlas Stent for Intracranial Aneurysm Treatment
Withdrawn	`NCT01194388` - Axium Coil in Completing Endovascular Aneurysm Surgery Study
Completed	`NCT00071565` - Familial Intracranial Aneurysm Study II	N/A
Recruiting	`NCT05409989` - MicroVention, Inc. Flow Re-Direction Endoluminal Device X (FRED™ X™) Post-Approval Study	N/A
Completed	`NCT03680742` - Contour Neurovascular System - European Pre-Market Unruptured Aneurysm	N/A
Completed	`NCT04872842` - Establishment of Online Registration Platform for Unruptured Intracranial Aneurysms Based on 100 Regional Medical Centers in China and Population Follow-up Study
Terminated	`NCT02532517` - Study to Evaluate the Safety and Effectiveness of the CODMAN ENTERPRISE® Vascular Reconstruction Device	N/A
Completed	`NCT03663257` - Study to Evaluate Cerebral AneurysmFlow Results in Occlusion
Recruiting	`NCT06189950` - Registration Trial of the Intracranial Visualized Stent for the Wide-necked Intracranial Aneurysms:REBRIDGE	N/A
Recruiting	`NCT05608122` - Establishment of Online Registration Platform for Unruptured Intracranial Aneurysms Based on Regional Medical Centers in China and Population Follow-up Study (Phase Ⅱ)
Recruiting	`NCT03661463` - Unruptured Intracranial Aneurysm Aspirin Trial (UIAAT).	Phase 2
Completed	`NCT02609867` - A Feasibility Study to Evaluate the Safety and Effectiveness of Implantation of Flowise Cerebral Flow Diverter (Flowise)	N/A
Active, not recruiting	`NCT02292017` - Prospective Packing Density With Target Coils I	N/A
Active, not recruiting	`NCT01872741` - Minipterional Versus Pterional Craniotomy	N/A
Completed	`NCT00993057` - Efficiency of Two Glucose Sampling Protocols for Maintenance of Euglycemia	Early Phase 1
Completed	`NCT00777088` - Pipeline for Uncoilable or Failed Aneurysms	N/A
Completed	`NCT00777907` - Complete Occlusion of Coilable Aneurysms	Phase 3