Coronary DiseaseVICTORYNCT05346068

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

A study testing OPN™ NCB Super High Pressure PCI Balloon and Shockwave™ C2 IVL Catheter in people with Coronary Disease and Coronary Artery Disease, run by Luzerner Kantonsspital at 1 site in Switzerland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronary Disease, Coronary Artery Disease, Calcific Coronary Arteriosclerosis
What is being tested?: OPN™ NCB Super High Pressure PCI Balloon and Shockwave™ C2 IVL Catheter
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 280 participants
Where: 1 siteSwitzerland
Study dates: 22 Nov 2022to 30 May 2028
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

None listed.

Who cannot join

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;

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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.
Angiographic exclusion criteria:
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);
Flow limiting target vessel thrombus (evident on angiography or OCT);
Definite or possible thrombus (by angiography or intravascular imaging) in the target vessel;
Evidence of aneurysm in target vessel within 10 mm of the target lesion.
Of note, only qualified physicians who are investigators or a sub-investigators for the trial will assess each individual´s eligibility criteria and take the final decision to include the subject in the trial (ICH GCP 4.3.1). This decision will be documented prior to the subject receiving the first intervention.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Florim Cuculi, MD contact

+41412052134

florim.cuculi@luks.ch

Switzerland1 site, 1 recruiting

Luzerner Heart Centre
Lucerne, 6000
Florim Cuculi, MD, +41412052134, florim.cuculi@luks.ch
Recruiting

Other trials in Switzerland

About this study

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

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.

Read the 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

Conditions: Coronary Disease, Coronary Artery Disease, Calcific Coronary Arteriosclerosis, Stent Restenosis, Coronary Artery Calcification
Being tested: OPN™ NCB Super High Pressure PCI Balloon, Shockwave™ C2 IVL Catheter
Medical subject headings: Coronary Disease, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OPN™ NCB Super High Pressure PCI BalloonDevice
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.
Shockwave™ C2 IVL CatheterDevice
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 groups in NCT05346068
Study group	Role	What they receive
Study Device	Experimental	Not described Receives: Device: OPN™ NCB Super High Pressure PCI Balloon
Control Device	Active comparator	Not described Receives: Device: Shockwave™ C2 IVL Catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

Final stent expansion (in percentage, %) assessed by OCT
Measured: At index Procedure

Secondary outcomes (4)

Acceptable stent expansion (>80%) assessed by OCT
Measured: At index Procedure
Optimal stent expansion (>90%) assessed by OCT
Measured: At index Procedure
Procedural success
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
Measured: At index Procedure
Strategy success
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).
Measured: At index Procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Nov 202230 May 2028

First posted26 Apr 2022
Study start22 Nov 2022
Primary completion31 Dec 2025 (estimated)
Study completion30 May 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Coronary DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 280 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05346068
Sponsor's protocol ID: VICTORY Trial
Acronym: VICTORY
Status last verified: Jun 2024
First submitted: 31 Mar 2022
Last updated: 18 Jun 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 36085285
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.
PubMed 36907698
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.
PubMed 32076567

Interested in taking part?

Florim Cuculi, MD

+41412052134

florim.cuculi@luks.ch

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05346068
Acronym / sponsor ID: VICTORY / VICTORY Trial
Conditions: Coronary Disease, Coronary Artery Disease, Calcific Coronary Arteriosclerosis, Stent Restenosis, Coronary Artery Calcification
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 280 participants (estimated)
Lead sponsor: Luzerner KantonsspitalUniversity, hospital or other
Collaborators: Hôpital Fribourgeois, Hamilton General Hospital
Study start: 22 Nov 2022 (actual)
Primary completion: 31 Dec 2025 (estimated)
Study completion: 30 May 2028 (estimated)
First posted: 26 Apr 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Study Device	Experimental	Device: OPN™ NCB Super High Pressure PCI Balloon
Control Device	Active comparator	Device: Shockwave™ C2 IVL Catheter

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (0 listed)

Key exclusion criteria (20 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OPN™ NCB Super High Pressure PCI BalloonIn 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	Study Device
Shockwave™ C2 IVL CatheterIn 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	Control Device

Primary outcome

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

4 secondary outcomes

Acceptable stent expansion (>80%) assessed by OCT
Time frame: At index Procedure
Optimal stent expansion (>90%) assessed by OCT
Time frame: At index Procedure
Procedural success
Time frame: At index Procedure
Strategy success
Time frame: At index Procedure

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
Background: PubMed 36085285Seiler 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.
Background: PubMed 36907698Pinilla-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.
Background: PubMed 32076567Cuculi 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Florim Cuculi, MD contact

+41412052134

florim.cuculi@luks.ch

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Florim Cuculi, MD (+41412052134, florim.cuculi@luks.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Final stent expansion (in percentage, %) assessed by OCT (time frame: At index Procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05346068, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2024.