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

NCT06168422 | Recruiting DMC

• 1 other identifier: HenanICE202312
• Study Type: observational
• Target: 2,100
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Heart Disease

Outcome Measures

Primary Outcomes (1)

• MACEs

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

  12 months

Secondary Outcomes (5)

• Cardiac Death

  12 months

• Myocardial Infarction

  12 months

• Target Vessel Revascularization

  12 months

• Stroke

  12 months

• BRCA 2,3-5

  12 months

Study Arms (3)

DES Group

All lesions in these patients were treated with DES

Device: DES

DES+DCB Group

These patients were treated using a combination of DES and DCB

Device: DES; Device: DCB

DCB Group

All lesions in these patients were treated with DCB

Device: DCB

Interventions

DES DEVICE

drug eluting stent

DES Group; DES+DCB Group

DCB DEVICE

drug-coated balloon

DCB Group; DES+DCB Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Elderly patients with calcified coronary artery disease

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henan Institute of Cardiovascular Epidemiology: lead

Study Sites (1)

Fuwai Central China Cardiovascular Hospital

Zhengzhou, Henan, China

RECRUITING

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Muwei Li

  Fuwai central China cardiovascular hospotial

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Quan Guo

CONTACT

+8615670510031; xinyiguoquan@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: December 13, 2023
• Study Start: December 25, 2023
• Primary Completion: January 1, 2025
• Study Completion: May 6, 2025
• Last Updated: June 27, 2024

Record last verified: 2024-06

Locations

CN (1)