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

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.

Conditions

• Coronary Disease
• Coronary Artery Disease
• Calcific Coronary Arteriosclerosis
• Stent Restenosis
• Coronary Artery Calcification

Interventions

DEVICE

OPN™ NCB Super High Pressure PCI Balloon

In order to permit advancement of the studied medical devices - OPN™ NCB or Shockwave™ IVL balloon catheter - initial lesion preparation using small SCBs or NCBs (≤2mm) or rotablation (Boston Scientific, Marlborough, MA, United States) is allowed, but will be documented. This may be required in selected cases with very calcified and tight lesions. As per protocol, lesion preparation will be performed using either the super-high pressure PCI balloon OPN™ NCB or the Shockwave™ IVL balloon catheter according to random treatment assignment after matching the angiographic and/or OCT inclusion criteria. Following successful lesion preparation all patients will be treated with a latest generation durable polymer everolimus-eluting stent (Xience™ Sierra or Skypoint, Abbott Vascular Inc., Santa Clara, CA, United States) to allow comparison of stent expansion.

DEVICE

Shockwave™ C2 IVL Catheter

In order to permit advancement of the studied medical devices - OPN™ NCB or Shockwave™ IVL balloon catheter - initial lesion preparation using small SCBs or NCBs (≤2mm) or rotablation (Boston Scientific, Marlborough, MA, United States) is allowed, but will be documented. This may be required in selected cases with very calcified and tight lesions. As per protocol, lesion preparation will be performed using either the super-high pressure PCI balloon OPN™ NCB or the Shockwave™ IVL balloon catheter according to random treatment assignment after matching the angiographic and/or OCT inclusion criteria. Following successful lesion preparation all patients will be treated with a latest generation durable polymer everolimus-eluting stent (Xience™ Sierra or Skypoint, Abbott Vascular Inc., Santa Clara, CA, United States) to allow comparison of stent expansion.

Sponsors & Collaborators

• Hôpital Fribourgeois

  collaborator OTHER

• Hamilton General Hospital

  collaborator UNKNOWN

• Luzerner Kantonsspital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-11-22

Primary Completion

2025-12-31

Completion

2028-05-30

Countries

• Switzerland

Study Locations