RECRUITINGOBSERVATIONAL
A Cohort Study of PCI Strategies for Severely Calcified Lesions of Complex Coronary Arteries in the Elderly
About This Trial
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 two groups and assigned different PCI strategies, either stenting or stenting combined with pharmacologic balloon implantation. The investigators will assess the one-year prognosis for major adverse cardiovascular events in these patients.
Who May Be Eligible (Plain English)
Who May Qualify:
1. Age ≥ 60 years;
2. Meet the indications for coronary intervention;
3. 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);
4. The diameter of the target lesion vessel is greater than 2.75mm;
5. 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.
Who Should NOT Join This Trial:
1. inability to provide written willing to sign a consent form;
2. inability to administer antiplatelet agents and anticoagulant therapy;
3. the subject is participating in other unfinished clinical trials;
4. life expectancy \<1 year;
5. non-in situ vascular lesions;
6. patients with haemodynamic instability;
7. Previous stroke within 6 months.
8. left main stem lesions.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
1. Age ≥ 60 years;
2. Meet the indications for coronary intervention;
3. 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);
4. The diameter of the target lesion vessel is greater than 2.75mm;
5. 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 Criteria:
1. inability to provide written informed consent;
2. inability to administer antiplatelet agents and anticoagulant therapy;
3. the subject is participating in other unfinished clinical trials;
4. life expectancy \<1 year;
5. non-in situ vascular lesions;
6. patients with haemodynamic instability;
7. Previous stroke within 6 months.
8. left main stem lesions.
Treatments Being Tested
DEVICE
DES
drug eluting stent
DEVICE
DCB
drug-coated balloon
Locations (1)
Fuwai Central China Cardiovascular Hospital
Zhengzhou, Henan, China