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

Coronary Heart Disease Clinical Trial

— PSSCCE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06168422
• Other study ID #: HenanICE202312
• Status: Recruiting
• Start date: December 25, 2023
• Est. completion date: May 6, 2025

Study information

• Verified date: March 2024
• Source: Henan Institute of Cardiovascular Epidemiology
• Contact: Quan Guo
• Phone: +8615670510031
• Email: xinyiguoquan[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2100
• Est. completion date: May 6, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Device:
• DES
drug eluting stent
• DCB
drug-coated balloon

Locations

Country	Name	City	State
China	Fuwai Central China Cardiovascular Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Henan Institute of Cardiovascular Epidemiology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MACEs	A Composite Event Including Cardiac Death, Myocardial Infarction, Stroke, and Target Vessel Revascularization	12 months
Secondary	Cardiac Death	Cardiac Death	12 months
Secondary	Myocardial Infarction	Myocardial Infarction	12 months
Secondary	Target Vessel Revascularization	Target Vessel Revascularization	12 months
Secondary	Stroke	Stroke	12 months
Secondary	BRCA 2,3-5	BRCA 2,3-5	12 months