Ignite Creation Date:
2024-05-06 @ 7:09 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05916898
Status:
RECRUITING
Last Update Posted:
2023-06-23
First Post:
2023-05-25
Brief Title:
The Lower Silesia Shockwave Registry
Sponsor:
Regional Cardiology Center The Copper Health Centre MCZ
Organization:
Regional Cardiology Center The Copper Health Centre MCZ
Study Overview
Official Title:
Evaluation of the Safety and Efficiency of ShockWave Intravascular Lithotripsy S-IVL in Coronary Artery Diseases The Lower Silesia Shockwave Registry LSSR
Status:
RECRUITING
Status Verified Date:
2023-06
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:
LSSR
Brief Summary:
Lower Silesia Shockwave Registry LSSR is a observational registry collecting all consecutive cases of percutaneous coronary intervention PCI performed with the support of shockwave intravascular lithotripsy in two cooperating cardiac centers Department of Cardiology The Copper Health Centre Lubin Poland and Department of Cardiology Provincial Specialized Hospital in Legnica Poland
Detailed Description:
This study contains data from the Lower Silesia Shockwave Registry LSSR collecting all consecutive cases of percutaneous coronary interventions PCI performed with the support of shockwave intravascular lithotripsy from two cooperating cardiac centers Department of Cardiology The Copper Health Centre Lubin Poland and Department of Cardiology Provincial Specialized Hospital in Legnica Poland
All patients involved in the study had a clinical indication for PCI based on current European Society of Cardiology ESC revascularisation guidelines if necessary with the support of the local heart team
Patients enrolled in the study had to meet one of two main inclusion criteria The presence of a highly calcified resistant lesion or a significantly under-expanded previously implanted stent regardless of the time of implantation The lesion was defined as resistant after an unsuccessful high-pressure non-compliant NC balloon inflation at least 20 under expansion whit at least 16 atm The decision regarding initial lesion preparation was left to the operators dissertation and did not imply a recruitment process Patients meeting the inclusion criteria who initially underwent advanced debulking procedures orbital or rotational atherectomy were also recruited
There were no angiographic exclusion criteria regarding lesion anatomy regarding the length tortuosity severity or prior stent placement Operators supported by angiography assessment with optional intravascular imagining IVUSOCT determined the size of the S-IVL catheter and an appropriate number of pulses for optimal vessel preparation or management of an under-expanded coronary stent Drug-eluting stent DES implantation or use of drug-eluting balloon catheters was left at the discretion of the operator
The study had two primary endpoints- clinical success and safety outcome The Clinical success was defined as an effective stent deployment or the optimization of previously not fully expanded stent with less than 20 in-stent residual stenosis and the presence of Thrombolysis in Myocardial Infarction TIMI 3 flow at the end of the procedure
Safety outcomes were defined as procedural final serious angiographic complications procedural perforation abrupt closure slow flow or no-reflow unstable ventricular arrhythmias and device failure inability to cross the lesion malfunction or rapture Also adverse cardiac and cerebrovascular events MACCE were recorded The MACCE consisted of death myocardial infarction acute cerebrovascular events and repeated revascularization of the target lesion Clinical follow-up was obtained by professional medical staff - personally or by telephone contacts periodically every 6 months after the index procedure The study has the approval of a local ethics committee Bioethical Committee at the Lower Silesian Medical Chamber - number of approval 04BOBD2022
All patients involved in the study had a clinical indication for PCI based on current European Society of Cardiology ESC revascularisation guidelines if necessary with the support of the local heart team
Patients enrolled in the study had to meet one of two main inclusion criteria The presence of a highly calcified resistant lesion or a significantly under-expanded previously implanted stent regardless of the time of implantation The lesion was defined as resistant after an unsuccessful high-pressure non-compliant NC balloon inflation at least 20 under expansion whit at least 16 atm The decision regarding initial lesion preparation was left to the operators dissertation and did not imply a recruitment process Patients meeting the inclusion criteria who initially underwent advanced debulking procedures orbital or rotational atherectomy were also recruited
There were no angiographic exclusion criteria regarding lesion anatomy regarding the length tortuosity severity or prior stent placement Operators supported by angiography assessment with optional intravascular imagining IVUSOCT determined the size of the S-IVL catheter and an appropriate number of pulses for optimal vessel preparation or management of an under-expanded coronary stent Drug-eluting stent DES implantation or use of drug-eluting balloon catheters was left at the discretion of the operator
The study had two primary endpoints- clinical success and safety outcome The Clinical success was defined as an effective stent deployment or the optimization of previously not fully expanded stent with less than 20 in-stent residual stenosis and the presence of Thrombolysis in Myocardial Infarction TIMI 3 flow at the end of the procedure
Safety outcomes were defined as procedural final serious angiographic complications procedural perforation abrupt closure slow flow or no-reflow unstable ventricular arrhythmias and device failure inability to cross the lesion malfunction or rapture Also adverse cardiac and cerebrovascular events MACCE were recorded The MACCE consisted of death myocardial infarction acute cerebrovascular events and repeated revascularization of the target lesion Clinical follow-up was obtained by professional medical staff - personally or by telephone contacts periodically every 6 months after the index procedure The study has the approval of a local ethics committee Bioethical Committee at the Lower Silesian Medical Chamber - number of approval 04BOBD2022
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None