Angina, UnstableNCT02760732
Drug Eluting Balloon for Treatment of Unstable Angina
A study testing drug eluting balloon; cutting balloon and drug eluting stent in people with Angina, Unstable, run by Yun Dai Chen at 1 site in China.
Trial summary
This study was to investigate the effect and safety of drug eluting balloon combined for treatment of unstable angina. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Angina, Unstable
- What is being tested?
- drug eluting balloon; cutting balloon and drug eluting stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Nov 2015to 1 Aug 2018
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients > 18, < 80 years old, with unstable angina
- Single-vessel or double-vessel disease
- Length of target lesion < 25mm
- Diameter of target vessel >2.5mm, < 3.5mm
Who cannot join
- Left main disease
- Chronic total occlusion
- Severe Tortuosity
- Heavy calcification
- Severe liver failure, moderate or severe kidney failure
- Malignant disease
- Active infectious disease
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The General Hospital of PLA
Beijing, Beijing Municipality, 100853
LI BO, MD, +8601055499309, 22401919@QQ.COM
About this study
Official title: Drug Eluting Balloon Combined With Cutting Balloon for Treatment of Unstable Angina
This study was to investigate the effect and safety of drug eluting balloon combined for treatment of unstable angina.
Read the detailed description
Patients with unstable angina were randomized to drug eluting stent only or drug eluting balloon group. Angiographic follow-up was performed after 12 months. The primary endpoints were late lumen loss (LLL) and the secondary endpoints were target lesion revascularization (TLR),and the major adverse cardiovascular events (MACE) .
- Conditions
- Angina, Unstable
- Being tested
- drug eluting balloon; cutting balloon, drug eluting stent
- Medical subject headings
- Angina, Unstable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
drug eluting balloon; cutting balloonDevice
Also called Sequent please; B. Braun; Flextome Cutting Balloon, Boston Scientific
Patients eligible for inclusion criteria were randomised to study group for percutaneous transluminal coronary angioplasty with a strategy of cutting balloon pre-dilation first and then drug eluting balloon.
drug eluting stentDevice
Also called YINYI®
with a strategy of drug-eluting stent implantation alone for de novo coronary artery lesions.
| Study group | Role | What they receive |
|---|---|---|
| drug eluting balloon group | Experimental | patients with unstable angina were randomised to drug eluting balloon group for percutaneous transluminal coronary angioplasty with a strategy of cutting balloon(Flextome Cutting Balloon, Boston Scientific Corporation, US) pre-dilation first and then drug eluting balloon(Sequent please; B. Braun, Melsungen, Germany) . Receives: Device: drug eluting balloon; cutting balloon |
| drug eluting stent group | Experimental | patients with unstable angina were randomised to this group for drug eluting stent (YINYI® Polymer-free Drug-coated (Paclitaxel) Coronary Stent System, Liaoning Biomedical Materials R\&D Center Co., Ltd. China) implantation. Receives: Device: drug eluting stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Target Lumen assessed by optical coherence tomography
A coronary de novo lesion in patient after intervened was measured with optical coherence tomography .To measure the changes in target lumen at 12 months.
Measured: 12 months
Secondary outcomes (1)
Incidence rate of MACE
MACE include composite of death, myocardial infarction, or target-vessel revascularization
Measured: Incidence rate of MACE from baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study startNov 2015
- Primary completion1 Jun 2018 (estimated)
- Study completion1 Aug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Angina, UnstableStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yun Dai Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yun Dai Chen, Chinese PLA General Hospital
- Investigators
- CHEN YUN DAI, MD, Principal investigator, The General Hospital of PLA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02760732
- Sponsor's protocol ID
- 301_xnk1
- Status last verified
- Nov 2017
- First submitted
- 29 Feb 2016
- Last updated
- 30 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Li B, Ding Y, Tian F, Chen W, Han T, Chen Y. Assessment of a Drug-Eluting Balloon for the Treatment of de novo Coronary Lesions Guided by Optical Coherence Tomography: Study Protocol for a Randomized Controlled Trial. Cardiology. 2017;136(4):252-257. doi: 10.1159/000452125. Epub 2016 Nov 16.
PubMed 27846629
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Eluting Balloon Combined With Cutting Balloon for Treatment of Unstable Angina
- ClinicalTrials.gov ID
- NCT02760732
- Acronym / sponsor ID
- 301_xnk1
- Conditions
- Angina, Unstable
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Yun Dai ChenUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- 1 Jun 2018 (estimated)
- Study completion
- 1 Aug 2018 (estimated)
- First posted
- 4 May 2016 (estimated)
- 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.
This study was to investigate the effect and safety of drug eluting balloon combined for treatment of unstable angina.
Detailed description
Patients with unstable angina were randomized to drug eluting stent only or drug eluting balloon group. Angiographic follow-up was performed after 12 months. The primary endpoints were late lumen loss (LLL) and the secondary endpoints were target lesion revascularization (TLR),and the major adverse cardiovascular events (MACE) .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| drug eluting balloon group | Experimental | Device: drug eluting balloon; cutting balloonpatients with unstable angina were randomised to drug eluting balloon group for percutaneous transluminal coronary angioplasty with a strategy of cutting balloon(Flextome Cutting Balloon, Boston Scientific Corporation, US) pre-dilation first and then drug eluting balloon(Sequent please; B. Braun, Melsungen, Germany) . |
| drug eluting stent group | Experimental | Device: drug eluting stentpatients with unstable angina were randomised to this group for drug eluting stent (YINYI® Polymer-free Drug-coated (Paclitaxel) Coronary Stent System, Liaoning Biomedical Materials R\&D Center Co., Ltd. China) implantation. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients > 18, < 80 years old, with unstable angina
- Single-vessel or double-vessel disease
- Length of target lesion < 25mm
- Diameter of target vessel >2.5mm, < 3.5mm
Key exclusion criteria (8 listed)
- Left main disease
- Chronic total occlusion
- Severe Tortuosity
- Heavy calcification
- Severe liver failure, moderate or severe kidney failure
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 eluting balloon; cutting balloonAlso: Sequent please; B. Braun; Flextome Cutting Balloon, Boston ScientificPatients eligible for inclusion criteria were randomised to study group for percutaneous transluminal coronary angioplasty with a strategy of cutting balloon pre-dilation first and then drug eluting balloon. | Device | drug eluting balloon group |
| drug eluting stentAlso: YINYI®with a strategy of drug-eluting stent implantation alone for de novo coronary artery lesions. | Device | drug eluting stent group |
Primary outcome
Changes in Target Lumen assessed by optical coherence tomography
Time frame: 12 months
A coronary de novo lesion in patient after intervened was measured with optical coherence tomography .To measure the changes in target lumen at 12 months.
1 secondary outcome
Incidence rate of MACE
Time frame: Incidence rate of MACE from baseline to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2017.
- Derived from this study: PubMed 27846629Li B, Ding Y, Tian F, Chen W, Han T, Chen Y. Assessment of a Drug-Eluting Balloon for the Treatment of de novo Coronary Lesions Guided by Optical Coherence Tomography: Study Protocol for a Randomized Controlled Trial. Cardiology. 2017;136(4):252-257. doi: 10.1159/000452125. Epub 2016 Nov 16.
- 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.
CHEN YUN DAI, MD principal investigator
The General Hospital of PLA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing drug eluting balloon; cutting balloon and drug eluting stent in people with Angina, Unstable, run by Yun Dai Chen 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 4 inclusion and 8 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 30 Nov 2017. 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?
Contact LI BO, MD (+8601055499309, 22401919@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Target Lumen assessed by optical coherence tomography (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02760732, which also lists 1 linked publication.
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 30 Nov 2017.