Back to resultsComparison of DCB and DES for Severe Calcification of de Novo Lesion in Elderly CHD
Primary Purpose
Coronary Artery Disease
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
DES
DCB
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria: 1. older than 60 years of age. 2. meeting the indications for coronary intervention. 3. 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); 4. Target lesion vessel diameter > 2.5 mm Exclusion Criteria: 1. inability to provide written informed consent. 2. unable to administer antiplatelet agents and anticoagulant therapy; have allergies to heparin, contrast agents, etc. 3. the subject is participating in another uncompleted clinical trial 4. life expectancy <1 year. 5. non-in situ vascular lesions. 6. cardiogenic shock. 7. Patients with hemodynamic instability
Sites / Locations
- Fuwai central China cardiovascular HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
DCB Group
DES Group
Arm Description
Implantation of drug-coated balloons in patients with satisfactory pretreatment
Implantation of drug-eluting stents in patients with satisfactory pretreatment
Outcomes
Primary Outcome Measures
LLL
Late lumen loss (LLL) of the target lesion segment
Secondary Outcome Measures
MACE
Cardiovascular death, target vessel revascularization, target vessel non-lethal myocardial infarction
Full Information
NCT ID
NCT05750771
First Posted
February 20, 2023
Last Updated
June 6, 2023
Sponsor
Henan Institute of Cardiovascular Epidemiology
1. Study Identification
Unique Protocol Identification Number
NCT05750771
Brief Title
Comparison of DCB and DES for Severe Calcification of de Novo Lesion in Elderly CHD
Official Title
Comparison of Drug-coated Balloon and Drug-eluting Stent for Severe Calcification of de Novo Lesion in Elderly Coronary Heart Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 20, 2023 (Actual)
Primary Completion Date
February 20, 2024 (Anticipated)
Study Completion Date
December 20, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Henan Institute of Cardiovascular Epidemiology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DCB Group
Arm Type
Experimental
Arm Description
Implantation of drug-coated balloons in patients with satisfactory pretreatment
Arm Title
DES Group
Arm Type
Experimental
Arm Description
Implantation of drug-eluting stents in patients with satisfactory pretreatment
Intervention Type
Device
Intervention Name(s)
DES
Intervention Description
Second-generation drug-eluting stents
Intervention Type
Device
Intervention Name(s)
DCB
Intervention Description
Drug-coated balloon with paclitaxel as drug coating
Primary Outcome Measure Information:
Title
LLL
Description
Late lumen loss (LLL) of the target lesion segment
Time Frame
12 months
Secondary Outcome Measure Information:
Title
MACE
Description
Cardiovascular death, target vessel revascularization, target vessel non-lethal myocardial infarction
Time Frame
Perioperative period, 30 days, 3 months, 6 months, 12 months after discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. older than 60 years of age.
2. meeting the indications for coronary intervention.
3. 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);
4. Target lesion vessel diameter > 2.5 mm
Exclusion Criteria:
1. inability to provide written informed consent.
2. unable to administer antiplatelet agents and anticoagulant therapy; have allergies to heparin, contrast agents, etc.
3. the subject is participating in another uncompleted clinical trial
4. life expectancy <1 year.
5. non-in situ vascular lesions.
6. cardiogenic shock.
7. Patients with hemodynamic instability
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Quan Guo, MD
Phone
+8615670510031
Email
xinyiguoquan@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muwei Li, MD
Organizational Affiliation
Fuwai central China cardiovascular hospotial
Official's Role
Study Chair
Facility Information:
Facility Name
Fuwai central China cardiovascular Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Quan Guo
Phone
+8615670510031
Email
xinyiguoquan@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of DCB and DES for Severe Calcification of de Novo Lesion in Elderly CHD
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