Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06558474
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
Optimization of Percutaenous Coronary Intervention With Liberal Use of Post-dilatation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Optimization of Percutaneous Coronary Intervention After Stent Implantation With Liberal Use of High-pressure Non-compliant Balloon Post-dilatation Versus Contemporary Practice
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPTIMIZE-PCI
Brief Summary:
To achieve optimal long-term clinical results after percutaneous coronary intervention PCI adequate deployment of stents is essential Thorough expansion of the stent and full apposition of stent struts against the vessel wall are determining factors for preventing stent thrombosis and restenosis for bare-metal as well as drug-eluting stents DES Standard coronary angiography is limited in assessing accurate vessel size and characterizing tissues and calcium load Therefore stent underexpansion frequently occurs after stent deployment
Post-dilation is often performed to achieve optimal stent expansion and reduce stent malapposition of stent struts aiming to reduce stent thrombosis and restenosis both short term as long term However there are limited studies that have explored the effect of post-dilatation for stent optimization on clinical outcomes As a result of the restricted evidence there is no consensus whether post-dilatation should be used routinely in clinical practice and the extent to which post-dilatation is being utilized remains unclear
We therefore designed the OPTIMIZE PCI a national registry-based quality improvement project to implement a liberal post-dilatation strategy in multiple PCI centers in the Netherlands As part of the OPTIMIZE-PCI a retrospective observational analysis will eventually be conducted to evaluate whether adopting this strategy has led to improved clinical outcomes after PCI in terms of MACE
Post-dilation is often performed to achieve optimal stent expansion and reduce stent malapposition of stent struts aiming to reduce stent thrombosis and restenosis both short term as long term However there are limited studies that have explored the effect of post-dilatation for stent optimization on clinical outcomes As a result of the restricted evidence there is no consensus whether post-dilatation should be used routinely in clinical practice and the extent to which post-dilatation is being utilized remains unclear
We therefore designed the OPTIMIZE PCI a national registry-based quality improvement project to implement a liberal post-dilatation strategy in multiple PCI centers in the Netherlands As part of the OPTIMIZE-PCI a retrospective observational analysis will eventually be conducted to evaluate whether adopting this strategy has led to improved clinical outcomes after PCI in terms of MACE
Detailed Description:
The NHR is an independent organization in which Dutch hospitals prospectively register standard sets of baseline procedural and outcome data for all invasive cardiac procedures including PCI Data provided to the NHR are extensively checked on completeness and quality reviewed with audit reports by independent trained research nurses and discussed by cardiologists in registration committees Multiple audits are conducted annually by the NHR for data validation and verification A waiver for informed consent for analysis with the data of the NHR data registry is obtained
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