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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-25

Study Completion Date

2025-05-06

Brief Summary

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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.

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Detailed Description

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Conditions

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Coronary Heart Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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DES Group

All lesions in these patients were treated with DES

DES

Intervention Type DEVICE

drug eluting stent

DES+DCB Group

These patients were treated using a combination of DES and DCB

DES

Intervention Type DEVICE

drug eluting stent

DCB

Intervention Type DEVICE

drug-coated balloon

DCB Group

All lesions in these patients were treated with DCB

DCB

Intervention Type DEVICE

drug-coated balloon

Interventions

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DES

drug eluting stent

Intervention Type DEVICE

DCB

drug-coated balloon

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No