Drug-coated BalloonNCT03691675
DCB in de Novo Coronary Lesion
A study testing Drug coated balloon in people with Drug-coated Balloon, run by Second Hospital of Jilin University.
Trial summary
Intro-stent restenosis, bifurcation lesions and small vascular lesion with diameter <2.75mm is the indication of drug coated balloon. In the era of traditional coronary artery balloon dilatation, it is believed that muscle fiber of coronary artery great vessels is more abundant than that of small vessels, and elastic… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Drug-coated Balloon
- What is being tested?
- Drug coated balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Oct 2018to Apr 2019
- 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
- At the age of 18-80 (18 and 80 included)
- The female at reproductive age shouldn't get pregnant or plan to get pregnant during the research
- Patients must agree to accept 3-month angiography follow-up
- Patients must agree to accept clinical follow-up on 30-day, 60-day and 90-day after operation
- Psychologically and linguistically, patients could have an understanding of the research purpose, revealing sufficient compliance with the research proposal. The patients' provision of the informed consent represents that the patient accepts the risks and benefits described in the informed consent.
- Target lesion diameter stenosis is ≥50%, and reference vascular diameter is ≥2.75mm
- De novo coronary lesion
- Type A lesion
Who cannot join
- Patients with myocardial infarction within one week
- Patients with congestive heart failure or severe NYHAIV heart failure
- Patients with severe valvular heart disease
- The female in pregnancy or lactation period
- Patients whose life expectancy don't exceed 1 year or who might have difficulty in clinical follow-up
- Patients who are of bleeding physique or forbidden to administer anticoagulants or antiplatelet drugs
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- Patients who suffered from cerebral stroke within 6 months prior to surgery
- Patients who are involved in any other clinical trials
- Patients who fail to satisfy angiography conditions due to currently suffering from or previously undergoing severe renal failure (GFR<30ml/min)
- Patients who underwent heart transplantation
- Patients who are deemed inappropriate for inclusion by the researcher due to other reasons
- Lesion of left main coronary artery
- Double vessel or triple vessel disease needed to be interventional treated
- Double vessel or triple vessel disease needed to be interventional treated
- Patients who are intolerant of aspirin and/or clopidogrel, have the medical history of neutrocytopenia or thrombocytopenia, or are forbidden to administer clopidogrel due to severe hepatic insufficiency
- Patients with known hypersensitivity
- Patients with the history of leukopenia (white blood cell count<3x109/L for over 3 days), or neutrocytopenia (ANCs <1,000 neutrophils/mm3 for over 3 days) or thrombocytopenia (blood platelets<100,000/mm3)
- Patients having the history of peptic ulcer or gastrointestinal bleeding within the past 6 months
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prospective Clinical Research on Safety and Efficacy of Drug Coated Balloon in de Novo Coronary Lesion With Diameters Larger Than 2.75 mm Under OCT Guidance
Intro-stent restenosis, bifurcation lesions and small vascular lesion with diameter <2.75mm is the indication of drug coated balloon. In the era of traditional coronary artery balloon dilatation, it is believed that muscle fiber of coronary artery great vessels is more abundant than that of small vessels, and elastic recoil and dissection are easier to appear upon dilatation, which will result in acute vascular occlusion and restenosis, so it is not recommended for great vessels to only receive PTCA therapy. But for patients with good angiography result without combination of serious dissections after predilation, the acute thrombosis seems to be a key factor for acute vascular occlusion. Traditional antiplatelet drug doesn't have a good effect, but the application of new-generation antiplatelet drug (clopidogrel, ticagrelor and tirofiban) has greatly reduced the occurrence rate of acute thrombosis. Therefore, under the guarantee of fully antiplatelet action of new-generation antiplatelet drug, for the patients with good angiography result without combination of serious dissections after predilation, Drug coated balloon seems to be an alternative of the stent. This research is to verify the safety and efficacy of Drug coated balloon in de novo coronary artery lesion with vascular diameter ≥2.75mm.
Read the detailed description
Stable or unstable angina patients who accept drug coated balloon dilatation therapy with diameter stenosis≥50%, reference diameter≥2.75mm will be enrolled. OCT examination should be carried out after radiography, predilation, Drug coated balloon dilatation and follow-up.
For target lesion, balloon should be used for predilation (the ratio of balloon diameter to vascular diameter being 0.8-1.0:1), and for good predilation effects, high pressure balloon, cutting balloon, dual-wire balloon and spines balloon can be adopted. OCT examination should be carry out after balloon satisfactory predilation. Satisfactory predilation radiography result is residual stenosis≤30%,TIMI 3 flow without major dissections (type C or higher) in NHLBI classification. OCT satisfactory result is residual stenosis≤30% without dissection, or with dissection but the dissection angle is ≤90°. Then carry out DCB balloon dilatation therapy. The ratio of balloon diameter to vascular diameter is 0.8-1.0:1, and both ends of DCB exceed the preprocessing area of lesion for 2-3mm, thus avoiding the occurrence of geographical mismatch. Dilation pressure is 8-10atm, lasting for at least 30s. Each DCB catheter can be used once only.
- Conditions
- Drug-coated Balloon
- Being tested
- Drug coated balloon
- Keywords
- Drug-coated balloon, restenosis, dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug coated balloonDevice
Patients with de novo lesion whose radiography showed that target lesion diameter stenosis is ≥50%, reference diameter is ≥2.75mm and who agreed with the Drug coated balloon dilatation therapy
| Study group | Role | What they receive |
|---|---|---|
| Drug coated balloon | Experimental | Patients with de novo lesion whose radiography showed that target lesion diameter stenosis is ≥50%, reference diameter is ≥2.75mm and who agreed with the Drug coated balloon dilatation therapy Receives: Device: Drug coated balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lumen loss in advanced stage of lesion segments within 3 months
Lumen loss in advanced stage of lesion segments within 3 months
Measured: 3 months
Secondary outcomes (6)
Success rate of interventional therapy (including device success rate, lesion success rate and clinical success rate)
Measured: 3 months
Occurrence rate of dissection after procedure
Measured: 3 months
Binary restenosis rate 3 months after procedure
Measured: 3 months
Cardiovascular clinical composite endpoints related to device at the time of 30 days, 60 days and 90days after the surgery include cardiac death, target vessel myocardial infarction and target lesion revascularization driven by clinical symptoms,
Measured: 3 months
Cardiovascular clinical composite endpoints related to patients at the time of 30 days, 60 days and 90 days after the surgery include all-cause mortality, all myocardial infarction and any revascularization
Measured: 3 months
ARC-defined occurrence rate of thrombotic events (identified, probable and non-excluded thrombosis during acute, subacute and advanced stage)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study startOct 2018 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug-coated BalloonStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Patients with de novo lesion whose radiography showed that target lesion diameter stenosis is ≥50%, reference diameter is ≥2.75mm and who agreed with the Drug coated balloon dilatation therapy
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Bin, Second Hospital of Jilin University
- Investigators
- Bin Liu, Doctor, Principal investigator, Second Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03691675
- Sponsor's protocol ID
- SecondJilinU-3
- Status last verified
- Sep 2018
- First submitted
- 28 Sep 2018
- Last updated
- 2 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Research on Safety and Efficacy of Drug Coated Balloon in de Novo Coronary Lesion With Diameters Larger Than 2.75 mm Under OCT Guidance
- ClinicalTrials.gov ID
- NCT03691675
- Acronym / sponsor ID
- SecondJilinU-3
- Conditions
- Drug-coated Balloon
- Keywords
- Drug-coated balloon, restenosis, dissection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Second Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- Oct 2018 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 2 Oct 2018 (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.
Intro-stent restenosis, bifurcation lesions and small vascular lesion with diameter <2.75mm is the indication of drug coated balloon. In the era of traditional coronary artery balloon dilatation, it is believed that muscle fiber of coronary artery great vessels is more abundant than that of small vessels, and elastic recoil and dissection are easier to appear upon dilatation, which will result in acute vascular occlusion and restenosis, so it is not recommended for great vessels to only receive PTCA therapy. But for patients with good angiography result without combination of serious dissections after predilation, the acute thrombosis seems to be a key factor for acute vascular occlusion. Traditional antiplatelet drug doesn't have a good effect, but the application of new-generation antiplatelet drug (clopidogrel, ticagrelor and tirofiban) has greatly reduced the occurrence rate of acute thrombosis. Therefore, under the guarantee of fully antiplatelet action of new-generation antiplatelet drug, for the patients with good angiography result without combination of serious dissections after predilation, Drug coated balloon seems to be an alternative of the stent. This research is to verify the safety and efficacy of Drug coated balloon in de novo coronary artery lesion with vascular diameter ≥2.75mm.
Detailed description
Stable or unstable angina patients who accept drug coated balloon dilatation therapy with diameter stenosis≥50%, reference diameter≥2.75mm will be enrolled. OCT examination should be carried out after radiography, predilation, Drug coated balloon dilatation and follow-up.
For target lesion, balloon should be used for predilation (the ratio of balloon diameter to vascular diameter being 0.8-1.0:1), and for good predilation effects, high pressure balloon, cutting balloon, dual-wire balloon and spines balloon can be adopted. OCT examination should be carry out after balloon satisfactory predilation. Satisfactory predilation radiography result is residual stenosis≤30%,TIMI 3 flow without major dissections (type C or higher) in NHLBI classification. OCT satisfactory result is residual stenosis≤30% without dissection, or with dissection but the dissection angle is ≤90°. Then carry out DCB balloon dilatation therapy. The ratio of balloon diameter to vascular diameter is 0.8-1.0:1, and both ends of DCB exceed the preprocessing area of lesion for 2-3mm, thus avoiding the occurrence of geographical mismatch. Dilation pressure is 8-10atm, lasting for at least 30s. Each DCB catheter can be used once only.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients with de novo lesion whose radiography showed that target lesion diameter stenosis is ≥50%, reference diameter is ≥2.75mm and who agreed with the Drug coated balloon dilatation therapy
| Arm | Type | Receives |
|---|---|---|
| Drug coated balloon | Experimental | Device: Drug coated balloonPatients with de novo lesion whose radiography showed that target lesion diameter stenosis is ≥50%, reference diameter is ≥2.75mm and who agreed with the Drug coated balloon dilatation therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- At the age of 18-80 (18 and 80 included)
- The female at reproductive age shouldn't get pregnant or plan to get pregnant during the research
- Patients must agree to accept 3-month angiography follow-up
- Patients must agree to accept clinical follow-up on 30-day, 60-day and 90-day after operation
- Psychologically and linguistically, patients could have an understanding of the research purpose, revealing sufficient compliance with the research proposal. The patients' provision of the informed consent represents that the patient accepts the risks and benefits described in the informed consent.
Key exclusion criteria (18 listed)
- Patients with myocardial infarction within one week
- Patients with congestive heart failure or severe NYHAIV heart failure
- Patients with severe valvular heart disease
- The female in pregnancy or lactation period
- Patients whose life expectancy don't exceed 1 year or who might have difficulty in clinical follow-up
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 |
|---|---|---|
| Drug coated balloonPatients with de novo lesion whose radiography showed that target lesion diameter stenosis is ≥50%, reference diameter is ≥2.75mm and who agreed with the Drug coated balloon dilatation therapy | Device | Drug coated balloon |
Primary outcome
Lumen loss in advanced stage of lesion segments within 3 months
Time frame: 3 months
Lumen loss in advanced stage of lesion segments within 3 months
6 secondary outcomes
Success rate of interventional therapy (including device success rate, lesion success rate and clinical success rate)
Time frame: 3 months
Occurrence rate of dissection after procedure
Time frame: 3 months
Binary restenosis rate 3 months after procedure
Time frame: 3 months
Cardiovascular clinical composite endpoints related to device at the time of 30 days, 60 days and 90days after the surgery include cardiac death, target vessel myocardial infarction and target lesion revascularization driven by clinical symptoms,
Time frame: 3 months
Cardiovascular clinical composite endpoints related to patients at the time of 30 days, 60 days and 90 days after the surgery include all-cause mortality, all myocardial infarction and any revascularization
Time frame: 3 months
ARC-defined occurrence rate of thrombotic events (identified, probable and non-excluded thrombosis during acute, subacute and advanced stage)
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2018.
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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.
Bin Liu, Doctor principal investigator
Second Hospital of Jilin University
Questions about this trial
What is this clinical trial studying?
A study testing Drug coated balloon in people with Drug-coated Balloon, run by Second Hospital of Jilin University.
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 8 inclusion and 18 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 2 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Bin Liu, Doctor (13500810268, liubin3333@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lumen loss in advanced stage of lesion segments within 3 months (time frame: 3 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 2 Oct 2018.