RecruitingNot Applicable

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

China2,100 participantsStarted 2023-12-25

Plain-language 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.

Who can participate

Age range60 Years

SexALL

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Inclusion criteria

✓. 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;
✓. 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

✕. 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;
✕. non-in situ vascular lesions;
✕. patients with haemodynamic instability;
✕. Previous stroke within 6 months.
✕. left main stem lesions.

What they're measuring

MACEs

Timeframe: 12 months

Trial details

NCT IDNCT06168422

SponsorHenan Institute of Cardiovascular Epidemiology

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-01-01

Contact for this trial

Quan Guo

+8615670510031 xinyiguoquan@163.com

View on ClinicalTrials.gov More Coronary Heart Disease trials