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

NCT05346068 | Recruiting DMC

• 1 other identifier: VICTORY Trial
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Final stent expansion (in percentage, %) assessed by OCT

  At index Procedure

Secondary Outcomes (4)

• Acceptable stent expansion (>80%) assessed by OCT

  At index Procedure

• Optimal stent expansion (>90%) assessed by OCT

  At index Procedure

• Procedural success

  At index Procedure

• Strategy success

  At index Procedure

Other Outcomes (19)

• Coronary perforations (Ellis grade III and/or cavity spilling)

  At index Procedure

• Persistent periprocedural vessel occlusion/MI

  At index Procedure

• Periprocedural ventricular tachycardia/fibrillation (VT/ VF)

  At index Procedure

Study Arms (2)

Study Device

EXPERIMENTAL

Device: OPN™ NCB Super High Pressure PCI Balloon

Control Device

ACTIVE COMPARATOR

Device: Shockwave™ C2 IVL Catheter

Interventions

OPN™ NCB Super High Pressure PCI Balloon DEVICE

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.

Study Device

Shockwave™ C2 IVL Catheter DEVICE

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.

Control Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years and consentable;
• Acute or chronic coronary artery disease with ischemia related symptoms (e.g. angina) and/or evidence of myocardial ischemia (e.g. FFR/ iFR, CMR, SPECT or PET-CT);
• Angiographically-proven coronary artery disease;
• Lesions in non-target vessels requiring PCI may be treated either
• prior to the study procedure if the procedure was unsuccessful or complicated; or
• in the same session if feasible and safe for the patient, otherwise a staged PCI procedure for non-target vessels may be considered;
• Informed Consent signed by the subject.
• Single de novo target lesion stenosis of protected LMCA, or LAD, RCA or LCX (or of their branches) with\*:
• Stenosis of ≥70%;
• Stenosis ≥50% and \<70% (visually assessed) with evidence of ischemia via positive stress test, or fractional flow reserve value ≤0.80, or iFR \<0.90 or IVUS minimum lumen area ≤4.0 mm²;
• The target vessel reference diameter must be ≥2.5 mm \& ≤4.5mm;
• AND AT LEAST ONE OF THE FOLLOWING CRITERIA:
• Evidence of calcification at the lesion site by angiography (Grade 3), with fluoroscopic radio-opacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location and total length of calcium of at least 15 mm and extending partially into the target lesion,
• AND/ OR by OCT, with presence of ≥270° calcium;
• AND/ OR Prior attempt at PCI with inability to expand a balloon in target lesion.

You may not qualify if:

• Patient experienced an acute STEMI or cardiogenic shock related to an acute MI within 2 days prior to index procedure;
• Any comorbidity or condition which may reduce compliance with this protocol, including follow-up calls/ visits (e.g. advanced dementia);
• Any medical, geographic, and/or social factor making study participation impractical or precluding required follow-up.
• Patient is pregnant or nursing (a negative pregnancy test is required for women of child-bearing potential within 7 days prior to enrollment);
• Unable to take a P2Y12 inhibitor (i.e. clopidogrel, prasugrel, or ticagrelor) for at least 6 months;
• Patient has an allergy to imaging contrast media which cannot be adequately pre-medicated;
• Renal failure with an eGFR \<30ml/min1.73m2;
• History of a stroke or transient ischemic attack (TIA) within 7 days, or any prior intracranial hemorrhage;
• Active peptic ulcer or upper gastrointestinal (GI) bleeding within 6 months;
• Untreated pre-procedural hemoglobin \<10g/dL or intention to refuse blood transfusions if one should become necessary;
• Patient has an allergy or intolerance to cobalt-chromium and/ or everolimus.
• Life expectancy of less than 1 year.
• Anatomy where the device or OCT catheter are unlikely to be delivered due to tortuosity or other characteristics;
• Target lesion is in a coronary artery bypass graft;
• Target lesion is an in-stent restenosis (ISR);

Sponsors & Collaborators

• Luzerner Kantonsspital: lead
• Hôpital Fribourgeois: collaborator
• Hamilton General Hospital: collaborator

Study Sites (1)

Luzerner Heart Centre

Lucerne, 6000, Switzerland

RECRUITING

Related Publications (3)

• Seiler T, Attinger-Toller A, Cioffi GM, Madanchi M, Teufer M, Wolfrum M, Moccetti F, Toggweiler S, Kobza R, Bossard M, Cuculi F. Treatment of In-Stent Restenosis Using a Dedicated Super High-Pressure Balloon. Cardiovasc Revasc Med. 2023 Jan;46:29-35. doi: 10.1016/j.carrev.2022.08.018. Epub 2022 Aug 20.

  PMID: 36085285 BACKGROUND

• Pinilla-Echeverri N, Bossard M, Hillani A, Chavarria JA, Cioffi GM, Dutra G, Guerrero F, Madanchi M, Attinger A, Kossmann E, Sibbald M, Cuculi F, Sheth T. Treatment of Calcified Lesions Using a Dedicated Super-High Pressure Balloon: Multicenter Optical Coherence Tomography Registry. Cardiovasc Revasc Med. 2023 Jul;52:49-58. doi: 10.1016/j.carrev.2023.02.020. Epub 2023 Mar 2.

  PMID: 36907698 BACKGROUND

• Cuculi F, Bossard M, Zasada W, Moccetti F, Voskuil M, Wolfrum M, Malinowski KP, Toggweiler S, Kobza R. Performing percutaneous coronary interventions with predilatation using non-compliant balloons at high-pressure versus conventional semi-compliant balloons: insights from two randomised studies using optical coherence tomography. Open Heart. 2020 Jan 23;7(1):e001204. doi: 10.1136/openhrt-2019-001204. eCollection 2020.

  PMID: 32076567 BACKGROUND

MeSH Terms

Conditions

Coronary Disease; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Central Study Contacts

Florim Cuculi, MD

CONTACT

+41412052134; florim.cuculi@luks.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Prospective, randomized, multicenter, non-inferiority trial with blinded assessment of outcomes (PROBE design)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Principal Investigator

Study Record Dates

• First Submitted: March 31, 2022
• First Posted: April 26, 2022
• Study Start: November 22, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): May 30, 2028
• Last Updated: June 18, 2024

Record last verified: 2024-06

Locations

CH (1)