Ignite Creation Date:
2024-05-06 @ 3:53 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04796038
Status:
COMPLETED
Last Update Posted:
2023-01-25
First Post:
2021-02-10
Brief Title:
Rise Semi Compliant Balloon Study in Patient With CAD
Sponsor:
Biosensors Europe SA
Organization:
Biosensors Europe SA
Study Overview
Official Title:
Evaluation of the Acute Safety and Device Success of the RISE SC Coronary Balloon Dilatation Catheter When Used as a Dilatation Device in the Stenotic Portion of a Coronary Artery or Bypass Graft in Patients With Coronary Artery Disease
Status:
COMPLETED
Status Verified Date:
2022-06
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:
None
Brief Summary:
Single arm prospective multi-center trial designed to enrol approximately 66 patients All patients will undergo PCI using at least one RISE SC balloon as per routine clinical practice and will be followed until discharge for data collection Patients will be enrolled in up to 5 investigational sites in Switzerland
The patients will be followed up until discharge or until 7 days whichever comes first
The patients will be followed up until discharge or until 7 days whichever comes first
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None