Ignite Creation Date:
2024-05-06 @ 1:16 AM
Last Modification Date:
2024-10-26 @ 11:01 AM
Study NCT ID:
NCT01761591
Status:
TERMINATED
Last Update Posted:
2014-08-26
First Post:
2012-12-12
Brief Title:
Acrobat Coronary Stent System Effectiveness European Study
Sponsor:
Svelte Medical Systems Europe
Organization:
Svelte Medical Systems Europe
Study Overview
Official Title:
Acrobat Coronary Stent System Effectiveness European Study European Multicenter Effectiveness Randomized Study of Svelte Medical Systems Acrobat Stent on a Wire Compared to Other BMS PCI in de Novo Coronary Lesions ACES Trial
Status:
TERMINATED
Status Verified Date:
2014-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficulty to identify eligible patients 8 centers contributed 54 patients in 6 months
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACES
Brief Summary:
The purpose of this randomized controlled trial RCT is to demonstrate the clinical benefit and impact on resource utilization of percutaneous coronary interventions PCI with the Svelte Acrobat Stent System compared to any other CE marked bare metal stent BMS implantable via direct stenting or after lesion pre-dilation in patients with coronary lesions that are eligible for direct stenting and who are recruited and treated so as to reflect real-life routine practice
Detailed Description:
The main objectives of this study are to test the following hypotheses
1 The evaluated stent is clinically non-inferior to control BMS in terms of freedom of MACE
2 The evaluated stent is clinically beneficial compared to control BMS by reducing exposure to radiations amount of contrast medium administered procedure time as well as amount of administered heparin
3 The evaluated stent does not result in more frequent adverse events than control BMS
4 The evaluated stent improves direct stenting success while not decreasing procedural success compared to control BMS
5 Resource utilization RU
1 Hospital-perspective resource utilization during the index admission and index procedure is not greater with evaluated the stent and potentially lower than with control BMS
2 Resource utilization over a 6-month time-horizon in relation to routine follow-up and MACE is not greater with the evaluated stent than with control BMS
1 The evaluated stent is clinically non-inferior to control BMS in terms of freedom of MACE
2 The evaluated stent is clinically beneficial compared to control BMS by reducing exposure to radiations amount of contrast medium administered procedure time as well as amount of administered heparin
3 The evaluated stent does not result in more frequent adverse events than control BMS
4 The evaluated stent improves direct stenting success while not decreasing procedural success compared to control BMS
5 Resource utilization RU
1 Hospital-perspective resource utilization during the index admission and index procedure is not greater with evaluated the stent and potentially lower than with control BMS
2 Resource utilization over a 6-month time-horizon in relation to routine follow-up and MACE is not greater with the evaluated stent than with control BMS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ID RCB 2012-A00670-43 | OTHER | ANSM | None |