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

June 25, 2024 updated by: Henan Institute of Cardiovascular Epidemiology
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

2100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China
        • Recruiting
        • Fuwai Central China Cardiovascular Hospital
        • Contact:
        • Principal Investigator:
          • Muwei Li, phd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Elderly patients with calcified coronary artery disease

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
DES Group
All lesions in these patients were treated with DES
Device: DES
drug eluting stent
DES+DCB Group
These patients were treated using a combination of DES and DCB
Device: DES
drug eluting stent
Device: DCB
drug-coated balloon
DCB Group
All lesions in these patients were treated with DCB
Device: DCB
drug-coated balloon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACEs
Time Frame: 12 months
A Composite Event Including Cardiac Death, Myocardial Infarction, Stroke, and Target Vessel Revascularization
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Myocardial Infarction
Time Frame: 12 months
Myocardial Infarction
12 months
Stroke
Time Frame: 12 months
Stroke
12 months
Target Vessel Revascularization
Time Frame: 12 months
Target Vessel Revascularization
12 months
Cardiac Death
Time Frame: 12 months
Cardiac Death
12 months
BRCA 2,3-5
Time Frame: 12 months
BRCA 2,3-5
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henan Institute of Cardiovascular Epidemiology

Investigators

  • Principal Investigator: Muwei Li, Fuwai central China cardiovascular hospotial

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 25, 2023

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

May 6, 2025

Study Registration Dates

First Submitted

December 5, 2023

First Submitted That Met QC Criteria

December 5, 2023

First Posted (Actual)

December 13, 2023

Study Record Updates

Last Update Posted (Actual)

June 27, 2024

Last Update Submitted That Met QC Criteria

June 25, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HenanICE202312

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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