Coronary Artery DiseaseNCT04744571
Safety and Efficacy of Drug-Coated Balloon Angioplasty for the Treatment of Chronic Total Occlusions
A study testing aspirin, betaloc, atorvastatin, rosuvastatin, clopidogrel, ticagrelor, coronary wires. or coronary balloons and drug-coated balloon in people with Coronary Artery Disease and Coronary Occlusion, run by Beijing Anzhen Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Coronary Occlusion, Percutaneous Coronary Intervention
- What is being tested?
- aspirin, betaloc, atorvastatin, rosuvastatin, clopidogrel, ticagrelor, coronary wires. or coronary balloons and drug-coated balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Feb 2021to Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100029
About this study
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.
Read the 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.
- Conditions
- Coronary Artery Disease, Coronary Occlusion, Percutaneous Coronary Intervention, Chronic Total Occlusion of Coronary Artery, Drug-Eluting Stents
- Being tested
- aspirin, betaloc, atorvastatin, rosuvastatin, clopidogrel, ticagrelor, coronary wires. or coronary balloons, drug-coated balloon, drug-eluting stent
- Keywords
- Chronic Total Occlusion, drug-coated balloon, balloon angioplasty, drug-eluting stent
- Medical subject headings
- Coronary Artery Disease, Coronary Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aspirin, betaloc, atorvastatin, rosuvastatin, clopidogrel, ticagrelorDrug
Also called Optimal medical therapy
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.
coronary wires. or coronary balloonsDevice
all species of coronary wires, or plain balloons
drug-coated balloonOther
Drug-coated balloon including all sizes and all brands
drug-eluting stentDevice
Drug-eluting stent including all sizes and all brands
| Study group | Role | What they receive |
|---|---|---|
| DCB group | Experimental | Patients treated with Drug-Coated Balloon Angioplasty after revascularization of Chronic Total Occlusions Receives: Drug: aspirin, betaloc, atorvastatin, rosuvastatin, clopidogrel, ticagrelor; Device: coronary wires. or coronary balloons; Other: drug-coated balloon |
| DES group | Active comparator | Patients treated with Drug eluting stents Angioplasty after revascularization of Chronic Total Occlusions Receives: Drug: aspirin, betaloc, atorvastatin, rosuvastatin, clopidogrel, ticagrelor; Device: coronary wires. or coronary balloons; Device: drug-eluting stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the difference in minimal lumen diameter (MLD) between two groups
Measured by Intravascular ultrasound (IVUS) or optical coherence tomography (OCT)
Measured: 12 months
Secondary outcomes (2)
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
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study startFeb 2021 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiantao Song, MD, Beijing Anzhen Hospital
- Investigators
- xiantao song, MD, Principal investigator, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04744571
- Sponsor's protocol ID
- DCB at CTO
- Status last verified
- Feb 2021
- First submitted
- 1 Feb 2021
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Drug-Coated Balloon Angioplasty for the Treatment of Chronic Total Occlusions
- ClinicalTrials.gov ID
- NCT04744571
- Acronym / sponsor ID
- DCB at CTO
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- Feb 2021 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 9 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DCB group | Experimental | Drug: aspirin, betaloc, atorvastatin, rosuvastatin, clopidogrel, ticagrelor, Device: coronary wires. or coronary balloons, Other: drug-coated balloonPatients treated with Drug-Coated Balloon Angioplasty after revascularization of Chronic Total Occlusions |
| DES group | Active comparator | Drug: aspirin, betaloc, atorvastatin, rosuvastatin, clopidogrel, ticagrelor, Device: coronary wires. or coronary balloons, Device: drug-eluting stentPatients treated with Drug eluting stents Angioplasty after revascularization of Chronic Total Occlusions |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aspirin, betaloc, atorvastatin, rosuvastatin, clopidogrel, ticagrelorAlso: Optimal medical therapyOptimal 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. | Drug | DCB group, DES group |
| coronary wires. or coronary balloonsall species of coronary wires, or plain balloons | Device | DCB group, DES group |
| drug-coated balloonDrug-coated balloon including all sizes and all brands | Other | DCB group |
| drug-eluting stentDrug-eluting stent including all sizes and all brands | Device | DES group |
Primary outcome
Comparison of the difference in minimal lumen diameter (MLD) between two groups
Time frame: 12 months
Measured by Intravascular ultrasound (IVUS) or optical coherence tomography (OCT)
2 secondary outcomes
Comparison of the incidence of major adverse cardiac events（MACEs） between two groups
Time frame: 12 months
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)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
xiantao song, MD principal investigator
Beijing Anzhen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aspirin, betaloc, atorvastatin, rosuvastatin, clopidogrel, ticagrelor, coronary wires. or coronary balloons and drug-coated balloon in people with Coronary Artery Disease and Coronary Occlusion, run by Beijing Anzhen Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the difference in minimal lumen diameter (MLD) between two groups (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2021.