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/36085285/Actively Recruiting
Led by Luzerner Kantonsspital · Updated on 2024-10-29
5000
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are collecting detailed information about patients with complex andor calcified chronic coronary artery disease CAD who have undergone percutaneous coronary intervention PCI or coronary artery bypass grafting CABG, as well as those managed medically. The study aims to compare clinical outcomes among these treatment groups and to understand how different PCI devices and CABG techniques affect cardiovascular health. It also examines patient subgroups such as those with diabetes or different ages and genders, evaluating their treatment differences and outcomes. The study observes patients receiving PCI, CABG, or medical management, gathering data on procedural results like blood flow and device performance in PCI, surgical details in CABG, and medical therapy regimens in conservatively managed patients. It analyzes short and long-term outcomes, including heart attacks, strokes, heart failure, bleeding, and death. The study also investigates predictors of treatment success or failure, economic aspects, and non-invasive testing methods. Participants provide baseline and clinical data and are followed over time to assess major adverse cardiac and cerebrovascular events MACCE up to 10 years after treatment. Researchers collect information on repeat procedures, hospitalizations, and complications through clinical evaluations. The study monitors safety and treatment effects continuously, aiming to improve understanding of how different management strategies impact patients with complex CAD.
CONDITIONS
COMPLEX Registry - a Prospective COhort Study to Describe the Management and Outcomes of Patients Presenting with CompLEX and Calcified Coronary Artery Disease
F
Florim Cuculi, MD
M
Matthias Bossard, MD
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Luzerner Kantonsspital
Lead Sponsor
You may qualify if you...
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure day and immediate peri-procedural period
Participants who undergo PCI or CABG procedures are observed during the implementation of current PCI techniques, devices, and surgical strategies for complex coronary artery lesions.
1 visit on procedure day
Duration - Up to 10 years
Participants are followed to assess clinical outcomes including cardiac events, revascularization, complications, and mortality over time.
Follow-up visits at 1 year, 2 years, 5 years, and 10 years
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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https://pubmed.ncbi.nlm.nih.gov/35498044/Luzerner Kantonsspital
Lead Sponsor