Skip to content

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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06168422
Acronym
PSSCCE
Enrollment
2100
Registered
2023-12-13
Start date
2023-12-25
Completion date
2025-05-06
Last updated
2024-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Heart Disease

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 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.

Interventions

DEVICEDES

drug eluting stent

DEVICEDCB

drug-coated balloon

Sponsors

Henan Institute of Cardiovascular Epidemiology
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
MACEs12 monthsA Composite Event Including Cardiac Death, Myocardial Infarction, Stroke, and Target Vessel Revascularization

Secondary

MeasureTime frameDescription
Cardiac Death12 monthsCardiac Death
Myocardial Infarction12 monthsMyocardial Infarction
Target Vessel Revascularization12 monthsTarget Vessel Revascularization
Stroke12 monthsStroke
BRCA 2,3-512 monthsBRCA 2,3-5

Countries

China

Contacts

Primary ContactQuan Guo
xinyiguoquan@163.com+8615670510031

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026