A Cohort Study of PCI Strategies for Severely Calcified Lesions of Complex Coronary Arteries in the Elderly (PSSCCE)

Henan Institute of Cardiovascular Epidemiology

Status: Enrolling

Conditions: Coronary Heart Disease

Treatments: Device: DES; Device: DCB

Study type: Observational

Funder types: Other

Identifiers

NCT06168422

HenanICE202312

Details and patient eligibility

About

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.

Enrollment: 2,100 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

2,100 participants in 3 patient groups

DES Group

Description:

All lesions in these patients were treated with DES

Treatment:

Device: DES

DES+DCB Group

Description:

These patients were treated using a combination of DES and DCB

Treatment:

Device: DCB

Device: DES

DCB Group

Description:

All lesions in these patients were treated with DCB

Treatment:

Device: DCB