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

Last updated: June 25, 2024
Sponsor: Henan Institute of Cardiovascular Epidemiology
Overall Status: Active - Recruiting

Phase

N/A

Condition

Coronary Artery Disease

Thrombosis

Chest Pain

Treatment

DES

DCB

Clinical Study ID

NCT06168422
HenanICE202312
  • Ages > 60
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥ 60 years;

  2. Meet the indications for coronary intervention;

  3. IVUS examination suggests severe calcified lesions (calcification angle >270°) orOCT examination suggests severe calcified lesions (calcification angle >180° and/orlength >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 betreated is ≥3 and/or the number of vessels to be treated is ≥2.

Exclusion

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.

Study Design

Total Participants: 2100
Treatment Group(s): 2
Primary Treatment: DES
Phase:
Study Start date:
December 25, 2023
Estimated Completion Date:
May 06, 2025

Connect with a study center

  • Fuwai Central China Cardiovascular Hospital

    Zhengzhou, Henan
    China

    Active - Recruiting

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