Comparison of DCB and DES for Severe Calcification of de Novo Lesion in Elderly CHD
Comparison of Drug-coated Balloon and Drug-eluting Stent for Severe Calcification of de Novo Lesion in Elderly Coronary Heart Disease
1 other identifier
interventional
200
1 country
1
Brief Summary
The goal of this clinical trial was to compare the effectiveness of drug balloons versus drug-coated stents in calcified lesions in elderly coronary artery disease. The main question it aims to answer is whether the application of DCB is non-inferior to DES for in situ large vessel calcified lesions in the elderly coronary arteries. And to develop a method to precisely identify the nature and extent of calcified lesions and to rationalize the choice of pretreatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable coronary-artery-disease
Started Feb 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2023
CompletedStudy Start
First participant enrolled
February 20, 2023
CompletedFirst Posted
Study publicly available on registry
March 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 20, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2025
CompletedJune 26, 2024
June 1, 2024
2.2 years
February 20, 2023
June 25, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
LLL
Late lumen loss (LLL) of the target lesion segment
12 months
Secondary Outcomes (1)
MACE
Perioperative period, 30 days, 3 months, 6 months, 12 months after discharge
Study Arms (2)
DCB Group
EXPERIMENTALImplantation of drug-coated balloons in patients with satisfactory pretreatment
DES Group
EXPERIMENTALImplantation of drug-eluting stents in patients with satisfactory pretreatment
Interventions
Eligibility Criteria
You may qualify if:
- \. older than 60 years of age.
- \. meeting the indications for coronary intervention.
- \. IVUS examination suggests severe calcified lesions (calcification angle \> 270° at the target lesion) or OCT examination suggests severe calcified lesions (calcification angle \> 180° and/or length \> 5 mm and/or thickness \> 0.5 mm);
- \. Target lesion vessel diameter \> 2.5 mm
You may not qualify if:
- \. inability to provide written informed consent.
- \. unable to administer antiplatelet agents and anticoagulant therapy; have allergies to heparin, contrast agents, etc.
- \. the subject is participating in another uncompleted clinical trial
- \. life expectancy \<1 year.
- \. non-in situ vascular lesions.
- \. cardiogenic shock.
- \. Patients with hemodynamic instability
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fuwai central China cardiovascular Hospital
Zhengzhou, Henan, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Muwei Li, MD
Fuwai central China cardiovascular hospotial
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2023
First Posted
March 2, 2023
Study Start
February 20, 2023
Primary Completion
May 20, 2025
Study Completion
December 20, 2025
Last Updated
June 26, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share