Safety and Efficacy of Drug-Coated Balloon Angioplasty for the Treatment of Chronic Total Occlusions
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: DCB group Patients treated with Drug-Coated Balloon Angioplasty after revascularization of Chronic Total Occlusions |
Drug: aspirin, betaloc, atorvastatin, rosuvastatin, clopidogrel, ticagrelor
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.
Other Names:
Device: coronary wires. or coronary balloons
all species of coronary wires, or plain balloons
Other: drug-coated balloon
Drug-coated balloon including all sizes and all brands
|
| Active Comparator: DES group Patients treated with Drug eluting stents Angioplasty after revascularization of Chronic Total Occlusions |
Drug: aspirin, betaloc, atorvastatin, rosuvastatin, clopidogrel, ticagrelor
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.
Other Names:
Device: coronary wires. or coronary balloons
all species of coronary wires, or plain balloons
Device: drug-eluting stent
Drug-eluting stent including all sizes and all brands
|
Outcome Measures
Primary Outcome Measures
- Comparison of the difference in minimal lumen diameter (MLD) between two groups [12 months]
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 [12 months]
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) [12 months]
Myocardial viability in the territory supplied by the CTO artery by comparison of late gadolinium enhancement between two groups.
Other Outcome Measures
- Comparison of the incidence of adverse cardiac events between two groups in the perioperative period [7 days before and after procedure]
Outcome measures including acute coronary artery occlusion, acute vascular perforation, acute stent thrombosis, acute myocardial infarction, and cardiac death
Eligibility Criteria
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)
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Patients should present with left ventricular ejection fraction (LVEF) above 35% determined using transthoracic echocardiography
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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
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Lesion located in the left main artery (stenosis ≥50%)
-
Clinical diagnosis of rheumatic valvular disease
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Clinical diagnosis of severe arrhythmia
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With history of revascularization within the CTO artery
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Lesions unsuitable for PCI
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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)
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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
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Patients cannot tolerate dual antiplatelet treatment (DAPT)
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Patients are unable to communicate due to cognitive impairment, auditory or visual impairment
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University | Beijing | Beijing | China | 100029 |
Sponsors and Collaborators
- Beijing Anzhen Hospital
Investigators
- Principal Investigator: xiantao song, MD, Beijing Anzhen Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DCB at CTO