Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-27 @ 12:57 PM
Study NCT ID:
NCT06571760
Status:
COMPLETED
Last Update Posted:
2025-05-29
First Post:
2024-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Selective Pulmonary-artery Intervention to Reduce Acute Right-heart tEnsion-I
Sponsor:
Neptune Medical
Organization:
Study Overview
Official Title:
Selective Pulmonary-artery Intervention to Reduce Acute Right-heart tEnsion-I
Status:
COMPLETED
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPIRARE I
Brief Summary:
This study study is a prospective, single-arm, multicenter study to evaluate the safety and effectiveness of the Vertex Pulmonary Embolectomy System in participants presenting with clinical signs and symptoms of pulmonary embolism.
Detailed Description:
The study is a prospective, single-arm, multicenter study to evaluate the safety and effectiveness of the Vertex Pulmonary Embolectomy System in participants presenting with clinical signs and symptoms of acute pulmonary embolism.
The Vertex Pulmonary Embolectomy System is intended for the non-surgical removal of emboli and thrombi from blood vessels as a means for treating pulmonary embolism.
The Vertex Pulmonary Embolectomy System is intended for the non-surgical removal of emboli and thrombi from blood vessels as a means for treating pulmonary embolism.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: