The Value of IVL Compared To OPN Non-Compliant Balloons for Treatment of RefractorY Coronary Lesions (VICTORY) Trial

Not Applicable

Recruiting

Conditions: Calcific Coronary Arteriosclerosis
Coronary Disease
Stent Restenosis
Coronary Artery Calcification
Coronary Artery Disease

Interventions: Device: OPN™ NCB Super High Pressure PCI Balloon
Device: Shockwave™ C2 IVL Catheter

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.

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

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Study Device	OPN™ NCB Super High Pressure PCI Balloon	-
Control Device	Shockwave™ C2 IVL Catheter	-

Primary Outcome Measures

Name	Time	Method
Final stent expansion (in percentage, %) assessed by OCT	At index Procedure

Secondary Outcome Measures

Name	Time	Method
Strategy success	At index Procedure	defined as procedural success using the assigned study device and stent, without requirement for lesion preparation with further devices (i.e. cross-over to the non-assigned study devices or cutting/ scoring balloons).
Optimal stent expansion (>90%) assessed by OCT	At index Procedure
Acceptable stent expansion (>80%) assessed by OCT	At index Procedure
Procedural success	At index Procedure	defined as the achievement of angiographic success (residual stenosis of \<30%, no flow-limiting dissection and/or no no-reflow) without any major adverse cardiac events (MACE), which is defined as cardiac death, target vessel related myocardial infarction, TIA/ stroke and repeat revascularization (PCI or CABG) up to 30 days