Pushing the Boundaries: Drug-Coated Balloons to Treat a Calcified and Thrombotic Lesion in Acute Coronary Syndrome.
Giacomo Maria Cioffi, Mehdi Madanchi, Adrian Attinger-Toller...
https://pubmed.ncbi.nlm.nih.gov/36196027Actively Recruiting
Age: 18Years +
All Genders
ID04988685
SIROOP Registry - A Prospective Registry Study to Evaluate the Outcomes of Coronary Artery Disease Patients Treated With SIROlimus Or Paclitaxel Eluting Balloon Catheters
Led by Luzerner Kantonsspital · Updated on 2024-10-29
2000
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
Sponsors
L
Luzerner Kantonsspital
Lead Sponsor
U
University Hospital, Geneva
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating clinical outcomes in patients with coronary artery disease who have undergone percutaneous coronary intervention (PCI) using drug-coated balloons (DCBs) with either sirolimus or paclitaxel coatings. This prospective registry study aims to collect both retrospective and prospective data on baseline characteristics, procedural details, and clinical outcomes across various patient groups, including those with different coronary artery lesions and clinical presentations. The study focuses on assessing the impact of these DCBs on cardiovascular outcomes and identifying optimal treatment strategies. Participants receive treatment using currently available sirolimus or paclitaxel eluting balloon catheters during PCI, with device choice left to the operator. Data collected includes procedural success, complications, and performance of various DCBs alone or combined with other stents or scaffolds. The study also investigates lesion preparation methods, predictors of target lesion revascularization, angiographic and imaging findings, antithrombotic regimens, and economic implications of interventional treatments in coronary artery disease. Participants' data will be monitored over time for clinical outcomes such as myocardial infarction, unstable angina, target lesion failure and revascularization, stroke, bleeding, heart failure, and mortality at intervals including 180 days, 1, 2, and 5 years. Procedural details, complications, and long-term outcomes will be recorded and analyzed. The primary outcome measure is the rate of target lesion failure and revascularization at one year. This long-term observational study involves ongoing data collection to evaluate the safety and performance of DCBs in real-world clinical settings.
CONDITIONS
Brief Title
SIROOP Registry - A Prospective Registry Study to Evaluate the Outcomes of Coronary Artery Disease Patients Treated With SIROlimus Or Paclitaxel Eluting Balloon Catheters
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Subject is older than 18 years
- Patients with significant acute or chronic coronary de-novo lesions or in-stent restenosis lesions requiring PCI treatment
- Treatment with at least one drug-coated balloon during PCI
- Willingness to sign informed consent or have signed general consent
You will not qualify if you...
- Patient is younger than 18 years
- Unable or unwilling to provide informed consent
- Pregnancy or currently breastfeeding
- Indication for surgical revascularization
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 PCI treatment using drug-coated balloon catheters, including Sirolimus or Paclitaxel eluting balloons.
1 procedure visit (in-person)
Long-term Monitoring
Duration - Up to 5 years
Participants are monitored for clinical outcomes such as target lesion failure, major adverse cardiac and cerebrovascular events, and other cardiovascular events.
Follow-up visits at 180 days, 1 year, 2 years, and 5 years (in-person or remote)
Trial Site Locations
Total: 1 location
1
Luzerner Heart Centre
Lucerne, Canton of Lucerne, Switzerland, 6000
Actively Recruiting
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Research Team
F
Florim Cuculi, MD
M
Matthias Bossard, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Metal free percutaneous coronary interventions in all-comers: First experience with a novel sirolimus-coated balloon.
Mehdi Madanchi, Giacomo M Cioffi, Adrian Attinger-Toller...
https://pubmed.ncbi.nlm.nih.gov/36385601Treatment of coronary lesions with a novel crystalline sirolimus-coated balloon.
Mehdi Madanchi, Adrian Attinger-Toller, Varis Gjergjizi...
https://pubmed.ncbi.nlm.nih.gov/38414923Outcomes following coronary chronic total occlusion revascularization with drug-coated balloons.
Mehdi Madanchi, Matthias Bossard, Irena Majcen...
https://pubmed.ncbi.nlm.nih.gov/38441987