Ignite Creation Date:
2024-05-06 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 2:31 PM
Study NCT ID:
NCT05346068
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2022-03-31
Brief Title:
The Value of IVL Compared To OPN Non-Compliant Balloons for Treatment of RefractorY Coronary Lesions VICTORY Trial
Sponsor:
Luzerner Kantonsspital
Organization:
Luzerner Kantonsspital
Study Overview
Official Title:
The Value of IVL Compared To OPN Non-Compliant Balloons for Treatment of RefractorY Coronary Lesions VICTORY Trial - A Randomized Multicenter Non-inferiority Comparison of Shockwave Intravascular Lithotripsy IVL and the OPN Non-compliant Balloon for Treatment of Calcified and Refractory Coronary Lesions
Status:
RECRUITING
Status Verified Date:
2024-06
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:
VICTORY
Brief Summary:
Percutaneous coronary intervention PCI with drug-eluting stent DES implantation has become the dominant treatment strategy for patients with acute and chronic coronary artery disease CAD requiring revascularization Nonetheless PCI with stent implantation has some limitations and especially patients with severely calcified coronary lesions approximately 10-20 of all patients with CAD have an elevated risk for adverse outcomes including target lesion failure TLF and stent thrombosis ST
Several dedicated PCI devices have been developed for treatment of severely calcified lesions Whereas especially two of them have shown promising results in smaller prospective studies First the super high-pressure NC PCI balloon OPN NC SIS Medical AG Frauenfeld Switzerland has been shown to represent an effective and safe device for lesion preparation Second the lately introduced Shockwave intravascular lithotripsy IVL balloon catheter Shockwave Medical Santa Clara CA USA appears to be a safe and efficient alternative device for treatment of calcified coronary lesions However it remains unknown if the OPN NC balloon is non-inferior to to IVL regarding lesion preparation and completeness of stent expansion in severely calcified lesions
Several dedicated PCI devices have been developed for treatment of severely calcified lesions Whereas especially two of them have shown promising results in smaller prospective studies First the super high-pressure NC PCI balloon OPN NC SIS Medical AG Frauenfeld Switzerland has been shown to represent an effective and safe device for lesion preparation Second the lately introduced Shockwave intravascular lithotripsy IVL balloon catheter Shockwave Medical Santa Clara CA USA appears to be a safe and efficient alternative device for treatment of calcified coronary lesions However it remains unknown if the OPN NC balloon is non-inferior to to IVL regarding lesion preparation and completeness of stent expansion in severely calcified lesions
Detailed Description:
To evaluate final stent expansion following a strategy of lesion preparation with either the Shockwave C2 IVL Catheter Shockwave Medical Inc Santa Clara CA United States or a super high-Pressure NC PTCA Balloon OPN NC SIS Medical Distribution AG Frauenfeld Switzerland in patients with heavily calcified coronary lesions undergoing coronary stent implantation
To assess the safety of a strategy of using super high-pressure NC balloons compared to shockwave IVL for treatment of heavily calcified lesions which are treated with a contemporary drug eluting stent
Patients presenting with chronic or acute coronary artery disease and requiring PCI to a very calcified coronary artery lesion will either be randomized to preparation of that corresponding lesion using the control device Shockwave IVL balloon catheter or the study device the super high-pressure NC PCI Balloon OPN NC
The treatment of the calcified coronary lesion will be guided by use of intravascular imaging optical coherence tomography OCT
Enrolled patients will undergo follow-up at 30 days 1 year and 2 years
To assess the safety of a strategy of using super high-pressure NC balloons compared to shockwave IVL for treatment of heavily calcified lesions which are treated with a contemporary drug eluting stent
Patients presenting with chronic or acute coronary artery disease and requiring PCI to a very calcified coronary artery lesion will either be randomized to preparation of that corresponding lesion using the control device Shockwave IVL balloon catheter or the study device the super high-pressure NC PCI Balloon OPN NC
The treatment of the calcified coronary lesion will be guided by use of intravascular imaging optical coherence tomography OCT
Enrolled patients will undergo follow-up at 30 days 1 year and 2 years
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?:
False
Is an FDA AA801 Violation?:
None