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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60+
SponsorHenan Institute of Cardiovascular Epidemiology

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 60 years;

Meet the indications for coronary intervention;

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);

The diameter of the target lesion vessel is greater than 2.75mm;

Disqualifiers

inability to provide written informed consent;

inability to administer antiplatelet agents and anticoagulant therapy;

the subject is participating in other unfinished clinical trials;

life expectancy <1 year;

Trial population

Elderly patients with calcified coronary artery disease

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • DES

    Device

    drug eluting stent

  • DCB

    Device

    drug-coated balloon

Treatment groups

2,100 Participants
are divided into 3 treatment groups
Group A: DES Group1 intervention
Group B: DES+DCB Group2 interventions
Group C: DCB Group1 intervention

Trial outcomes

Primary outcomes

1

MACEs

A Composite Event Including Cardiac Death, Myocardial Infarction, Stroke, and Target Vessel Revascularization

Time frame
12 months

Secondary outcomes

1

Cardiac Death

Cardiac Death

Time frame
12 months
2

Myocardial Infarction

Myocardial Infarction

Time frame
12 months
3

Target Vessel Revascularization

Target Vessel Revascularization

Time frame
12 months
4

Stroke

Stroke

Time frame
12 months

Other outcomes

Sponsors and contacts

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