Coronary Artery DiseasePhase 4NCT01903902
Efficacy and Safety of Paclitaxel-eluting Balloon for Treatment of Lesions in Native Small Coronary Arteries
A Phase 4 study testing SeQuent® Please Drug-eluting balloon in people with Coronary Artery Disease, run by Gachon University Gil Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of paclitaxel-eluting balloon (SeQuent® Please) for treatment of lesions in native small coronary arteries. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- SeQuent® Please Drug-eluting balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2013to Jun 2015
- Phase
- Phase 4
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 19 years
- Patients who are appropriate for percutaneous coronary intervention using drug-eluting balloon in native small coronary artery (vessel diameter ≥ 2.25 mm and ≤ 2.75 mm, lesion length < 25 mm)
- Informed consent
Who cannot join
- Chronic total obstruction lesion
- Severe calcified lesion
- Left main coronary lesion
- Lesion having intravascular thrombus
- Shock status from any cause including cardiogenic shock
- Left ventricular ejection fraction < 30%
Show all 10Show fewer
- Need for coronary artery bypass surgery
- Allergic reaction for paclitaxel
- Severe allergic for contrast agent (Visipaque) or statin
- Pregnancy, breastfeeding or Expectation for pregnancy in women of childbearing age
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Gachon University Gil Medical Center
Incheon, 405-760
Woong Chul Kang, M.D., +82-32-460-3663, kangwch@gilhospital.com
Woong Chul Kang, M.D.
About this study
Official title: The Efficacy and Safety of Paclitaxel-eluting SeQuent Please Drug-Eluting Balloon for Treatment of lesiOns in Native smalL coronarY Arteries (DEB-ONLY)
The purpose of this study is to evaluate the efficacy and safety of paclitaxel-eluting balloon (SeQuent® Please) for treatment of lesions in native small coronary arteries.
Read the detailed description
Drug-eluting balloon (DEB) have emerged as a potential alternative to overcome the limitations of drug-eluting stents such as restenosis or stent thrombosis.
DEB angioplasty is proven to be effective clinically for the treatment of in-stent restenosis. However, DEB for de novo lesions, especially in small vessels is less studied.
The purpose of this study is to evaluate the efficacy and safety of paclitaxel-eluting balloon (SeQuent® Please) for treatment of lesions in native small coronary arteries.
- Conditions
- Coronary Artery Disease
- Being tested
- SeQuent® Please Drug-eluting balloon
- Keywords
- Coronary artery disease, Balloon angioplasty, Drug-eluting balloon
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeQuent® Please Drug-eluting balloonDevice
Balloon angioplasty using paclitaxel-eluting balloon (SeQuent® Please) will be done in native small coronary artery (vessel diameter ≥ 2.25 mm and ≤ 2.75 mm, and lesion length < 25 mm), if residual stenosis is ≤ 30% and there are no dissection of classification C and over which disturbed blood flow after plain balloon angioplasty.
| Study group | Role | What they receive |
|---|---|---|
| Drug-eluting balloon | Experimental | Balloon angioplasty using paclitaxel-eluting SeQuent Please drug-eluting balloon in native small coronary artery (vessel diameter > 2.25 mm and ≤ 2.75 mm) Receives: Device: SeQuent® Please Drug-eluting balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Late loss
Late loss of the target lesion at the follow-up (9±1 months) quantitative coronary
Measured: 9±1 months
Binary restenosis rate
Restenosis rate of the target lesion at the follow-up quantitative coronary angiography
Measured: 9±1 months
Secondary outcomes (2)
Neointimal hyperplasia
Neointimal hyperplasia of the target lesion at the follow-up intravascular ultrasound (IVUS) or optical coherence tomography (OCT) exam
Measured: 9±1 months
Clinical outcomes
Clinical outcomes including death, myocardial infarct, target lesion revascularization, stent thrombosis within the target lesion
Measured: 9±1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gachon University Gil Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Chung-Ang University Hospital, Inje University, Chonnam National University Hospital, Ulsan University Hospital, Jeju National University Hospital, Daegu Catholic University Medical Center, Chungbuk National University, Dankook University, The Catholic University of Korea, Kwandong University Myongji Hospital, Kosin University Gospel Hospital, Keimyung University Dongsan Medical Center, Soonchunhyang University Hospital, National Health Insurance Service Ilsan Hospital, Saint Carollo General Hospital, Chuncheon Sacred Heart Hospital, Sejong General Hospital, Cheju Halla General Hospital, Wonkwang University, Konyang University Hospital, Gangnam Severance Hospital, Hallym University Medical Center, Chonbuk National University Hospital, Korea University Guro Hospital
- Responsible party
- Principal investigator, Woong Chol Kang, Gachon University Gil Medical Center
- Investigators
- Woong Chul Kang, M.D., Principal investigator, Gachon University Gil Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01903902
- Sponsor's protocol ID
- DEB-ONLY
- Status last verified
- Jul 2013
- First submitted
- 17 Jul 2013
- Last updated
- 19 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Paclitaxel-eluting SeQuent Please Drug-Eluting Balloon for Treatment of lesiOns in Native smalL coronarY Arteries (DEB-ONLY)
- ClinicalTrials.gov ID
- NCT01903902
- Acronym / sponsor ID
- DEB-ONLY
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease, Balloon angioplasty, Drug-eluting balloon
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Gachon University Gil Medical CenterUniversity, hospital or other
- Collaborators
- Chung-Ang University Hospital, Inje University, Chonnam National University Hospital, Ulsan University Hospital, Jeju National University Hospital, Daegu Catholic University Medical Center, Chungbuk National University, Dankook University, The Catholic University of Korea, Kwandong University Myongji Hospital, Kosin University Gospel Hospital, Keimyung University Dongsan Medical Center, Soonchunhyang University Hospital, National Health Insurance Service Ilsan Hospital, Saint Carollo General Hospital, Chuncheon Sacred Heart Hospital, Sejong General Hospital, Cheju Halla General Hospital, Wonkwang University, Konyang University Hospital, Gangnam Severance Hospital, Hallym University Medical Center, Chonbuk National University Hospital, Korea University Guro Hospital
- Study start
- Jun 2013
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 19 Jul 2013 (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.
The purpose of this study is to evaluate the efficacy and safety of paclitaxel-eluting balloon (SeQuent® Please) for treatment of lesions in native small coronary arteries.
Detailed description
Drug-eluting balloon (DEB) have emerged as a potential alternative to overcome the limitations of drug-eluting stents such as restenosis or stent thrombosis.
DEB angioplasty is proven to be effective clinically for the treatment of in-stent restenosis. However, DEB for de novo lesions, especially in small vessels is less studied.
The purpose of this study is to evaluate the efficacy and safety of paclitaxel-eluting balloon (SeQuent® Please) for treatment of lesions in native small coronary arteries.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Drug-eluting balloon | Experimental | Device: SeQuent® Please Drug-eluting balloonBalloon angioplasty using paclitaxel-eluting SeQuent Please drug-eluting balloon in native small coronary artery (vessel diameter > 2.25 mm and ≤ 2.75 mm) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 19 years
- Patients who are appropriate for percutaneous coronary intervention using drug-eluting balloon in native small coronary artery (vessel diameter ≥ 2.25 mm and ≤ 2.75 mm, lesion length < 25 mm)
- Informed consent
Key exclusion criteria (10 listed)
- Chronic total obstruction lesion
- Severe calcified lesion
- Left main coronary lesion
- Lesion having intravascular thrombus
- Shock status from any cause including cardiogenic shock
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 |
|---|---|---|
| SeQuent® Please Drug-eluting balloonBalloon angioplasty using paclitaxel-eluting balloon (SeQuent® Please) will be done in native small coronary artery (vessel diameter ≥ 2.25 mm and ≤ 2.75 mm, and lesion length < 25 mm), if residual stenosis is ≤ 30% and there are no dissection of classification C and over which disturbed blood flow after plain balloon angioplasty. | Device | Drug-eluting balloon |
Primary outcome
Late loss
Time frame: 9±1 months
Late loss of the target lesion at the follow-up (9±1 months) quantitative coronary
Binary restenosis rate
Time frame: 9±1 months
Restenosis rate of the target lesion at the follow-up quantitative coronary angiography
2 secondary outcomes
Neointimal hyperplasia
Time frame: 9±1 months
Clinical outcomes
Time frame: 9±1 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2013.
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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.
Woong Chul Kang, M.D. principal investigator
Gachon University Gil Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SeQuent® Please Drug-eluting balloon in people with Coronary Artery Disease, run by Gachon University Gil Medical Center at 1 site in South Korea.
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 3 inclusion and 10 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 19 Jul 2013. 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 South Korea. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Woong Chul Kang, M.D. (+82-32-460-3663, kangwch@gilhospital.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Late loss (time frame: 9±1 months). The study lists 2 primary outcomes in all. 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 19 Jul 2013.