Treatment of In-Stent Restenosis Using a Dedicated Super High-Pressure Balloon.
Thomas Seiler, Adrian Attinger-Toller, Giacomo Maria Cioffi...
https://pubmed.ncbi.nlm.nih.gov/36085285Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID05346068
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
Led by Luzerner Kantonsspital · Updated on 2024-06-18
280
Participants Needed
1
Research Sites
125 weeks
Total Duration
On this page
Sponsors
L
Luzerner Kantonsspital
Lead Sponsor
H
Hôpital Fribourgeois
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating treatment strategies for patients with acute and chronic coronary artery disease who have severely calcified coronary lesions. These lesions, found in about 10-20% of patients needing revascularization, pose challenges such as higher risks of target lesion failure and stent thrombosis. The study compares two devices used for preparing these calcified lesions before stent placement: the super high-pressure OPN17 NC PCI balloon and the Shockwave intravascular lithotripsy (IVL) balloon catheter. Participants with heavily calcified coronary lesions will be randomly assigned to have their lesions prepared using either the Shockwave IVL catheter or the OPN17 NC balloon. Initial lesion preparation with smaller balloons or rotablation is allowed if needed. After lesion preparation, all patients will receive a latest-generation drug-eluting stent to treat the lesion. The treatment will be guided by intravascular imaging using optical coherence tomography (OCT). Throughout the study, participants will be monitored at the time of the procedure and will have follow-up visits at 30 days, 1 year, and 2 years after treatment. Researchers will assess the final stent expansion using OCT during the procedure and evaluate procedural and strategy success. Safety and effectiveness of each lesion preparation method will be closely observed during these visits.
CONDITIONS
Brief Title
The Value of IVL Compared To OPN Non-Compliant Balloons for Treatment of RefractorY Coronary Lesions (VICTORY) Trial
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older and able to give informed consent
- Acute or chronic coronary artery disease with ischemia-related symptoms or evidence of myocardial ischemia
- Coronary artery disease confirmed by angiography
- Single de novo target lesion with stenosis of 70% or more, or 50-69% with evidence of ischemia
- Target vessel diameter between 2.5 mm and 4.5 mm
- Lesion shows evidence of calcification by angiography or OCT or prior failed balloon expansion attempt
- Patients with lesions in non-target vessels may be treated before or during the study procedure if safe
- Signed informed consent form
You will not qualify if you...
- Acute STEMI or cardiogenic shock within 2 days before the procedure
- Conditions reducing compliance with the protocol, such as advanced dementia
- Medical, geographic, or social factors preventing study participation or follow-up
- Pregnancy or nursing (negative pregnancy test required for women of childbearing potential)
- Unable to take P2Y12 inhibitors for at least 6 months
- Allergy to imaging contrast media not manageable with pre-medication
- Severe kidney failure with eGFR less than 30 ml/min/1.73m2
- Recent stroke, transient ischemic attack, or prior brain bleeding
- Active peptic ulcer or recent upper gastrointestinal bleeding
- Low hemoglobin under 10 g/dL or refusal of blood transfusions
- Allergy or intolerance to cobalt-chromium or everolimus
- Life expectancy under 1 year
- Lesion location or anatomy unsuitable for device delivery
- Lesions in coronary artery bypass grafts or in-stent restenosis
- Presence of thrombus or aneurysm near the target lesion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Day of procedure
Participants undergo lesion preparation using either the Shockwave™ IVL balloon catheter or the super high-pressure PCI balloon OPN™ NCB, followed by implantation of a drug-eluting stent to treat heavily calcified coronary lesions.
1 procedure visit (in-person)
Follow-up
Duration - Up to 2 years
Participants are followed up to assess stent expansion and safety after the procedure.
Visits at 30 days, 1 year, and 2 years (in-person)
Trial Site Locations
Total: 1 location
1
Luzerner Heart Centre
Lucerne, Switzerland, 6000
Actively Recruiting
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Research Team
F
Florim Cuculi, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Treatment of Calcified Lesions Using a Dedicated Super-High Pressure Balloon: Multicenter Optical Coherence Tomography Registry.
Natalia Pinilla-Echeverri, Matthias Bossard, Ali Hillani...
https://pubmed.ncbi.nlm.nih.gov/36907698Performing 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.
Florim Cuculi, Matthias Bossard, Wojciech Zasada...
https://pubmed.ncbi.nlm.nih.gov/32076567