Actively Recruiting
A Cohort Study of PCI Strategies for Severely Calcified Lesions of Complex Coronary Arteries in the Elderly
Led by Henan Institute of Cardiovascular Epidemiology · Updated on 2024-06-27
2100
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare the outcomes of different percutaneous coronary intervention (PCI) strategies in elderly patients with complex, severely calcified coronary artery lesions. The study focuses on patients aged 60 years and older who have significant coronary heart disease involving complex calcified lesions. Researchers want to understand how various PCI methods affect the prognosis, especially the occurrence of major adverse cardiovascular events within one year. Participants are grouped based on the PCI strategy used to treat their coronary lesions. One group receives drug-eluting stents (DES) only, another group receives a combination of DES and drug-coated balloons (DCB), and a third group is treated with DCB alone. All lesions treated involve complex, severe calcification as assessed by imaging techniques. The study observes these treatment approaches as they are applied without altering clinical care. During the study, participants will be monitored for major adverse cardiovascular events over a 12-month period. Researchers will track outcomes such as cardiac death, myocardial infarction, target vessel revascularization, stroke, and specific cardiac events labeled BRCA 2,3-5. Data collection includes clinical assessments and follow-ups to evaluate the one-year prognosis after the PCI procedures. The total duration of participation corresponds with this year-long follow-up.
CONDITIONS
Brief Title
A Cohort Study of PCI Strategies for Severely Calcified Lesions of Complex Coronary Arteries in the Elderly
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 60 years or older
- Meet indications for coronary intervention
- Severe calcified lesions confirmed by IVUS or OCT imaging
- Diameter of target lesion vessel greater than 2.75 mm
- Total lesion length over 60 mm and/or three or more lesions and/or two or more vessels to be treated
You will not qualify if you...
- Unable to provide written informed consent
- Unable to receive antiplatelet or anticoagulant therapy
- Currently participating in other unfinished clinical trials
- Life expectancy less than 1 year
- Non-in situ vascular lesions
- Hemodynamic instability
- Stroke within the last 6 months
- Left main stem lesions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of procedure
Participants undergo treatment of severely calcified coronary artery lesions using drug-eluting stents, drug-coated balloons, or a combination of both devices.
1 visit (in-person)
Duration - 12 months
Participants are followed for up to 12 months to monitor major adverse cardiac events and other health outcomes.
Follow-up visits as per routine clinical care
Trial Site Locations
Total: 1 location
1
Fuwai Central China Cardiovascular Hospital
Zhengzhou, Henan, China
Actively Recruiting
Research Team
Q
Quan Guo
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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