Back to resultsSafety and Efficacy of Drug-Coated Balloon Angioplasty for the Treatment of Chronic Total Occlusions
Primary Purpose
Coronary Artery Disease, Coronary Occlusion, Percutaneous Coronary Intervention
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
aspirin, betaloc, atorvastatin, rosuvastatin, clopidogrel, ticagrelor
coronary wires. or coronary balloons
drug-coated balloon
drug-eluting stent
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Chronic Total Occlusion, drug-coated balloon, balloon angioplasty, drug-eluting stent
Eligibility Criteria
Inclusion Criteria
- Patients between 18 and 80 years of age
- Must comply all the evaluations and follow-up protocols
- Clinical diagnosis of CTO detected using coronary angiography (at least one other major vessel should have exhibited no less than 75% stenosis)
- Patients should present with left ventricular ejection fraction (LVEF) above 35% determined using transthoracic echocardiography
- CTO located in an epicardial coronary artery with a reference diameter of ≥ 2.5 mm
Exclusion Criteria
- Patients have suffered from acute myocardial infarction within the previous 3 months
- Lesion located in the left main artery (stenosis ≥50%)
- Clinical diagnosis of rheumatic valvular disease
- Clinical diagnosis of severe arrhythmia
- With history of revascularization within the CTO artery
- Lesions unsuitable for PCI
- Severely abnormal hematopoietic systems, such as platelet counts <100 x 109/L or > 700 x 109/ L and white blood cell counts < 3 x 109/L
- Patients with active bleeding or bleeding tendencies (active ulcers, short-term ischemic stroke, history of hemorrhagic stroke, intracranial space occupying lesions, recent craniocerebral trauma, and other bleeding or bleeding tendency)
- Patients with severe coexisting condition including: severe renal function dysfunction [Glomerular filtration rate (GFR) less than 60 ml/min • 1.73 m2), severe hepatic dysfunction [glutamic-pyruvic transaminase (ALT) or glutamic-oxal acetic transaminase (ALT) elevated more than three times that of the upper limit of the normal reference], severe heart failure (NYHA classification III-IV), acute infectious diseases and immune disorders, tumors, surgery within 3 months, a life expectancy less than 12 months, pregnancy or planning to become pregnant, history of allergy or adverse reactions to aspirin, clopidogrel, ticagrelor, stains, contrast material, anticoagulant, or stents
- Patients cannot tolerate dual antiplatelet treatment (DAPT)
- Patients are unable to communicate due to cognitive impairment, auditory or visual impairment
- Patients are participating in another trial for medication or an apparatus and in which the main endpoint has not been reached, or plan to participate in a clinical trial within 12 months of the intervention
Sites / Locations
- Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
DCB group
DES group
Arm Description
Patients treated with Drug-Coated Balloon Angioplasty after revascularization of Chronic Total Occlusions
Patients treated with Drug eluting stents Angioplasty after revascularization of Chronic Total Occlusions
Outcomes
Primary Outcome Measures
Comparison of the difference in minimal lumen diameter (MLD) between two groups
Measured by Intravascular ultrasound (IVUS) or optical coherence tomography (OCT)
Secondary Outcome Measures
Comparison of the incidence of major adverse cardiac events（MACEs） between two groups
all-cause mortality, cardiac death, a first or recurrent, non-fatal, acute myocardial infarction, target lesion revascularization (PCI or CABG), stroke, heart failure and cardiac rehospitalization
Comparison of myocardial viability (late gadolinium enhancement, LGE) in the territory supplied by the CTO artery between two groups evaluated via cardiovascular magnetic resonance (CMR)
Myocardial viability in the territory supplied by the CTO artery by comparison of late gadolinium enhancement between two groups.
Full Information
NCT ID
NCT04744571
First Posted
February 1, 2021
Last Updated
February 6, 2021
Sponsor
Beijing Anzhen Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04744571
Brief Title
Safety and Efficacy of Drug-Coated Balloon Angioplasty for the Treatment of Chronic Total Occlusions
Official Title
Safety and Efficacy of Drug-Coated Balloon Angioplasty for the Treatment of Chronic Total Occlusions
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 2021 (Anticipated)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
January 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Anzhen Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to investigate the safety and efficacy of drug-coated balloon angioplasty for the treatment of chronic total occlusions patients with chronic total occlusion (CTO) lesion.
Detailed Description
Recruited CTO patients will be divided into two groups: those undergoing PCI of drug-coated balloon (DCB group), and those undergoing PCI of drug eluting stent implantation (DES group). The primary outcome assessed will be the late lumen loss evaluation at a 12-month of follow-up appointment. Secondary outcomes include occurrence of major cardiac events (MACEs), myocardial viability, operate success, quality of life changes which will be compared to a baseline measurement.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Coronary Occlusion, Percutaneous Coronary Intervention, Chronic Total Occlusion of Coronary Artery, Drug-Eluting Stents
Keywords
Chronic Total Occlusion, drug-coated balloon, balloon angioplasty, drug-eluting stent
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
Patients treated with Drug-Coated Balloon Angioplasty after revascularization of Chronic Total Occlusions
Arm Title
DES group
Arm Type
Active Comparator
Arm Description
Patients treated with Drug eluting stents Angioplasty after revascularization of Chronic Total Occlusions
Intervention Type
Drug
Intervention Name(s)
aspirin, betaloc, atorvastatin, rosuvastatin, clopidogrel, ticagrelor
Other Intervention Name(s)
Optimal medical therapy
Intervention Description
Optimal medical therapy includes dual antiplatelet therapy and statins (aspirin, clopidogrel, ticagrelor, atorvastatin, rosuvastatin, betaloc). And optimal medical therapy should include adequate ventricular rate- limiting medication (i.e. Beta- blocker or rate-limiting calcium antagonist) where appropriate. Anti- anginal therapy should be used if the patients have symptom.
Intervention Type
Device
Intervention Name(s)
coronary wires. or coronary balloons
Intervention Description
all species of coronary wires, or plain balloons
Intervention Type
Other
Intervention Name(s)
drug-coated balloon
Intervention Description
Drug-coated balloon including all sizes and all brands
Intervention Type
Device
Intervention Name(s)
drug-eluting stent
Intervention Description
Drug-eluting stent including all sizes and all brands
Primary Outcome Measure Information:
Title
Comparison of the difference in minimal lumen diameter (MLD) between two groups
Description
Measured by Intravascular ultrasound (IVUS) or optical coherence tomography (OCT)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Comparison of the incidence of major adverse cardiac events（MACEs） between two groups
Description
all-cause mortality, cardiac death, a first or recurrent, non-fatal, acute myocardial infarction, target lesion revascularization (PCI or CABG), stroke, heart failure and cardiac rehospitalization
Time Frame
12 months
Title
Comparison of myocardial viability (late gadolinium enhancement, LGE) in the territory supplied by the CTO artery between two groups evaluated via cardiovascular magnetic resonance (CMR)
Description
Myocardial viability in the territory supplied by the CTO artery by comparison of late gadolinium enhancement between two groups.
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Comparison of the incidence of adverse cardiac events between two groups in the perioperative period
Description
Outcome measures including acute coronary artery occlusion, acute vascular perforation, acute stent thrombosis, acute myocardial infarction, and cardiac death
Time Frame
7 days before and after procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Patients between 18 and 80 years of age
Must comply all the evaluations and follow-up protocols
Clinical diagnosis of CTO detected using coronary angiography (at least one other major vessel should have exhibited no less than 75% stenosis)
Patients should present with left ventricular ejection fraction (LVEF) above 35% determined using transthoracic echocardiography
CTO located in an epicardial coronary artery with a reference diameter of ≥ 2.5 mm
Exclusion Criteria
Patients have suffered from acute myocardial infarction within the previous 3 months
Lesion located in the left main artery (stenosis ≥50%)
Clinical diagnosis of rheumatic valvular disease
Clinical diagnosis of severe arrhythmia
With history of revascularization within the CTO artery
Lesions unsuitable for PCI
Severely abnormal hematopoietic systems, such as platelet counts <100 x 109/L or > 700 x 109/ L and white blood cell counts < 3 x 109/L
Patients with active bleeding or bleeding tendencies (active ulcers, short-term ischemic stroke, history of hemorrhagic stroke, intracranial space occupying lesions, recent craniocerebral trauma, and other bleeding or bleeding tendency)
Patients with severe coexisting condition including: severe renal function dysfunction [Glomerular filtration rate (GFR) less than 60 ml/min • 1.73 m2), severe hepatic dysfunction [glutamic-pyruvic transaminase (ALT) or glutamic-oxal acetic transaminase (ALT) elevated more than three times that of the upper limit of the normal reference], severe heart failure (NYHA classification III-IV), acute infectious diseases and immune disorders, tumors, surgery within 3 months, a life expectancy less than 12 months, pregnancy or planning to become pregnant, history of allergy or adverse reactions to aspirin, clopidogrel, ticagrelor, stains, contrast material, anticoagulant, or stents
Patients cannot tolerate dual antiplatelet treatment (DAPT)
Patients are unable to communicate due to cognitive impairment, auditory or visual impairment
Patients are participating in another trial for medication or an apparatus and in which the main endpoint has not been reached, or plan to participate in a clinical trial within 12 months of the intervention
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
xiantao song, MD
Organizational Affiliation
Beijing Anzhen Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Safety and Efficacy of Drug-Coated Balloon Angioplasty for the Treatment of Chronic Total Occlusions
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