Status:
RECRUITING
A Cohort Study of PCI Strategies for Severely Calcified Lesions of Complex Coronary Arteries in the Elderly
Lead Sponsor:
Henan Institute of Cardiovascular Epidemiology
Conditions:
Coronary Heart Disease
Eligibility:
All Genders
60+ years
Brief Summary
The aim of this observational study is to compare the prognostic outcomes of various PCI strategies in elderly patients with complex coronary calcified lesions. The patients will be classified into tw...
Eligibility Criteria
Inclusion
- Age ≥ 60 years;
- Meet the indications for coronary intervention;
- IVUS examination suggests severe calcified lesions (calcification angle \>270°) or OCT examination suggests severe calcified lesions (calcification angle \>180° and/or length \>5mm and/or thickness \>0.5mm);
- The diameter of the target lesion vessel is greater than 2.75mm;
- The total length of the lesion is more than 60mm and/or the number of lesions to be treated is ≥3 and/or the number of vessels to be treated is ≥2.
Exclusion
- inability to provide written informed consent;
- inability to administer antiplatelet agents and anticoagulant therapy;
- the subject is participating in other unfinished clinical trials;
- life expectancy \<1 year;
- non-in situ vascular lesions;
- patients with haemodynamic instability;
- Previous stroke within 6 months.
- left main stem lesions.
Key Trial Info
Start Date :
December 25 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 6 2025
Estimated Enrollment :
2100 Patients enrolled
Trial Details
Trial ID
NCT06168422
Start Date
December 25 2023
End Date
May 6 2025
Last Update
June 27 2024
Active Locations (1)
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1
Fuwai Central China Cardiovascular Hospital
Zhengzhou, Henan, China