Coronary Artery DiseasePhase 2DEBfirstNCT01539603
Comparison of Drug Eluting Balloon and Drug Eluting Stent
A Phase 2 study testing Drug eluting balloon + Bare metal stent and drug eluting stent (Zotarolimus-eluting stent) in people with Coronary Artery Disease and Stable Angina, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of Drug-Eluting Balloon first and then bare metal stent compared with drug-eluting stent for treatment of de novo lesions (DEB first). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Coronary Artery Disease, Stable Angina, Unstable Angina
- What is being tested?
- Drug eluting balloon + Bare metal stent and drug eluting stent (Zotarolimus-eluting stent)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2011to Feb 2015
- Phase
- Phase 2
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- De novo lesion
- 2.5mm =< Reference diameter =< 4mm
- Lesion length =< 28mm
- Type A, B1/B2 lesion
Who cannot join
- ST-segment elevation MI
- Reference diameter < 2.5mm or > 4mm
- Bifurcation lesion
- Type C lesion
- history of AMI or stroke within 1 year F. chronic renal disease (Cr > 2mg/dL)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National Universtiy Bundang Hospital
Seongnam, 463-707
About this study
Official title: Comparison of Drug-Eluting Balloon First and Then Bare Metal Stent With Drug-eluting Stent for Treatment of de Novo Lesions (DEB First): A Randomized Controlled Single Center Clinical Trial
The purpose of this study is to evaluate the safety and efficacy of Drug-Eluting Balloon first and then bare metal stent compared with drug-eluting stent for treatment of de novo lesions (DEB first).
Read the detailed description
A recent trial to test premount bare metal stent on drug-eluting balloon failed to demonstrate non-inferiority and safety compared to drug-eluting stent alone for treatment of coronary artery stenosis.
We think that inappropriate drug delivery to diseased vessel due to stent strut might affect the efficacy of drug-eluting balloon. Therefore, we design a clinical study with a different protocol, that is, drug-eluting balloon first and then bare metal stent implantation in comparison to drug-eluting stent.
- Conditions
- Coronary Artery Disease, Stable Angina, Unstable Angina, NSTEMI
- Being tested
- Drug eluting balloon + Bare metal stent, drug eluting stent (Zotarolimus-eluting stent)
- Keywords
- drug eluting balloon, bare metal stent, drug eluting stent, coronary artery disease
- Medical subject headings
- Coronary Artery Disease, Angina, Stable, Angina, Unstable, Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug eluting balloon + Bare metal stentDevice
Also called Sequent Please (B.Braun, drug eluting balloon), Coroflex Blue (B.Braun, bare metal stent)
PCI using Sequent Please and then Coroflex Blue
drug eluting stent (Zotarolimus-eluting stent)Device
Also called Endeavor integrity, Zotarolimus-eluting stent
conventional PCI using Endeavor Integrity
| Study group | Role | What they receive |
|---|---|---|
| DEB-BMS | Experimental | Drug eluting balloon + Bare metal stent Receives: Device: Drug eluting balloon + Bare metal stent |
| Drug eluting stent | Active comparator | conventional PCI with drug eluting stent drug eluting stent (Zotarolimus-eluting stent) Receives: Device: drug eluting stent (Zotarolimus-eluting stent) |
What is being measured
The primary outcome is the main question the study is designed to answer.
in-segment late loss
angiographic in-segment late loss measure by QCA program
Measured: 9 month
Secondary outcomes (3)
stent thrombosis
any stent thrombosis
Measured: 9 month
angiographic and procedure success
Angiographic success denotes that residual diameter stenosis is less than 10% without complication such as coronarhy dissection or thrombosis.
Procedural success means that adequate DEB+BMS or DES delivery to the target lesion without geographic miss.
Measured: 9 month
MACE
death, MI and TVF
Measured: 9 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2012 (estimated)
- Study startApr 2011
- Primary completionDec 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang-Hwan Yoon, Seoul National University Bundang Hospital
- Investigators
- In-Ho Chae, MD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01539603
- Sponsor's protocol ID
- E-1104/061-001
- Acronym
- DEBfirst
- Status last verified
- Jun 2015
- First submitted
- 21 Feb 2012
- Last updated
- 12 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chae IH, Yoon CH, Park JJ, Oh IY, Suh JW, Cho YS, Youn TJ, Choi DJ. Comparison of Drug-Eluting Balloon Followed by Bare Metal Stent with Drug-Eluting Stent for Treatment of de Novo Lesions: Randomized, Controlled, Single-Center Clinical Trial. J Korean Med Sci. 2017 Jun;32(6):933-941. doi: 10.3346/jkms.2017.32.6.933.
PubMed 28480650Park SD, Yoon CH, Oh IY, Suh JW, Cho YS, Youn TJ, Choi DJ, Chae IH. Comparison of a drug-eluting balloon first and then bare metal stent with a drug-eluting stent for treatment of de novo lesions: study protocol of a randomized controlled trial. Trials. 2013 Feb 8;14:38. doi: 10.1186/1745-6215-14-38.
PubMed 23394404
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Drug-Eluting Balloon First and Then Bare Metal Stent With Drug-eluting Stent for Treatment of de Novo Lesions (DEB First): A Randomized Controlled Single Center Clinical Trial
- ClinicalTrials.gov ID
- NCT01539603
- Acronym / sponsor ID
- DEBfirst / E-1104/061-001
- Conditions
- Coronary Artery Disease, Stable Angina, Unstable Angina, NSTEMI
- Keywords
- drug eluting balloon, bare metal stent, drug eluting stent, coronary artery disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 27 Feb 2012 (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 safety and efficacy of Drug-Eluting Balloon first and then bare metal stent compared with drug-eluting stent for treatment of de novo lesions (DEB first).
Detailed description
A recent trial to test premount bare metal stent on drug-eluting balloon failed to demonstrate non-inferiority and safety compared to drug-eluting stent alone for treatment of coronary artery stenosis.
We think that inappropriate drug delivery to diseased vessel due to stent strut might affect the efficacy of drug-eluting balloon. Therefore, we design a clinical study with a different protocol, that is, drug-eluting balloon first and then bare metal stent implantation in comparison to drug-eluting stent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DEB-BMS | Experimental | Device: Drug eluting balloon + Bare metal stentDrug eluting balloon + Bare metal stent |
| Drug eluting stent | Active comparator | Device: drug eluting stent (Zotarolimus-eluting stent)conventional PCI with drug eluting stent drug eluting stent (Zotarolimus-eluting stent) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- De novo lesion
- 2.5mm =< Reference diameter =< 4mm
- Lesion length =< 28mm
- Type A, B1/B2 lesion
Key exclusion criteria (5 listed)
- ST-segment elevation MI
- Reference diameter < 2.5mm or > 4mm
- Bifurcation lesion
- Type C lesion
- history of AMI or stroke within 1 year F. chronic renal disease (Cr > 2mg/dL)
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 + Bare metal stentAlso: Sequent Please (B.Braun, drug eluting balloon), Coroflex Blue (B.Braun, bare metal stent)PCI using Sequent Please and then Coroflex Blue | Device | DEB-BMS |
| drug eluting stent (Zotarolimus-eluting stent)Also: Endeavor integrity, Zotarolimus-eluting stentconventional PCI using Endeavor Integrity | Device | Drug eluting stent |
Primary outcome
in-segment late loss
Time frame: 9 month
angiographic in-segment late loss measure by QCA program
3 secondary outcomes
stent thrombosis
Time frame: 9 month
angiographic and procedure success
Time frame: 9 month
MACE
Time frame: 9 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2015.
- Derived from this study: PubMed 28480650Chae IH, Yoon CH, Park JJ, Oh IY, Suh JW, Cho YS, Youn TJ, Choi DJ. Comparison of Drug-Eluting Balloon Followed by Bare Metal Stent with Drug-Eluting Stent for Treatment of de Novo Lesions: Randomized, Controlled, Single-Center Clinical Trial. J Korean Med Sci. 2017 Jun;32(6):933-941. doi: 10.3346/jkms.2017.32.6.933.
- Derived from this study: PubMed 23394404Park SD, Yoon CH, Oh IY, Suh JW, Cho YS, Youn TJ, Choi DJ, Chae IH. Comparison of a drug-eluting balloon first and then bare metal stent with a drug-eluting stent for treatment of de novo lesions: study protocol of a randomized controlled trial. Trials. 2013 Feb 8;14:38. doi: 10.1186/1745-6215-14-38.
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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.
In-Ho Chae, MD principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Drug eluting balloon + Bare metal stent and drug eluting stent (Zotarolimus-eluting stent) in people with Coronary Artery Disease and Stable Angina, run by Seoul National University Bundang Hospital 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 12 Jun 2015. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
in-segment late loss (time frame: 9 month). 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 NCT01539603, which also lists 2 linked publications.
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 12 Jun 2015.