Coronary RestenosisPhase 4ELEGANTNCT02300454
Effect of Combination of Non-sLip Element Balloon (NSE) and druG-coated bAlloon (DCB) for In-steNT Restenosis Lesions
A Phase 4 study testing Non-slip element balloon (NSE) and Balloon in people with Coronary Restenosis, run by Mitsui Memorial Hospital at 2 sites in Japan.
Trial summary
Use of SeQuent® Please drug coated balloon (DCB) is effective to treat patients with in-stent restenosis (ISR). However, whether the type of pre-dilatation balloon prior to DCB dilatation impacts on clinical and angiographic outcomes or not is unknown. Read more about this study
- Who is it for?
- Ages 20 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Restenosis
- What is being tested?
- Non-slip element balloon (NSE) and Balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 2 sitesJapan
- Study dates
- Jun 2015to Apr 2019
- 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 20 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients with in-stent restenosis lesions who are planned to be treated with drug coating balloon
Who cannot join
- ST elevation myocardial infarction
- stent thrombosis
- severe renal dysfunction (eGFR <30 ml/min) except dialysis
- pregnancy
- planned surgery within 3 months
- shock vital
Trial locations and contacts
2 sites in 1 country.
Japan2 sites
Mitsui Memorial Hospital
Chiyoda-Ku, Tokyo
Tokai University
Isehara, Kanagawa
About this study
Use of SeQuent® Please drug coated balloon (DCB) is effective to treat patients with in-stent restenosis (ISR). However, whether the type of pre-dilatation balloon prior to DCB dilatation impacts on clinical and angiographic outcomes or not is unknown. Lacrosse® Non-slip element balloon (NSE) is a balloon catheter with 3 longitudinal plastic elements which are attached to proximal and distal balloon edges. NSE is developed to incise neointimal tissue and avoid balloon slippage without vitiating balloon derivability and crossability. We investigated angiographic and clinical outcomes following normal non-compliant balloon or NSE dilatation prior to DCB dilatation in ISR lesions.This study is a single blinded, multicenter, randomized trial. Total 200 patients with ISR are randomly assigned to treat with non-compliant balloon or NSE before DCB dilatation. Optical coherence tomographic (OCT) analysis are performed before pre-dilatation and after DCB dilatation Follow-up angiography analysis are planned at 8 months in all patients. Clinical follow-up is planned at 8 and 24 months.Primary endpoint is angiographic in-segment late loss at 8 months.
- Conditions
- Coronary Restenosis
- Being tested
- Non-slip element balloon (NSE), Balloon
- Keywords
- in-stent restenosis, percutaneous coronary intervention, balloon
- Medical subject headings
- Coronary Restenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-slip element balloon (NSE)Device
Lacrosse® NSE and SeQuent® Please drug coated balloon (DCB)
BalloonDevice
Non-compliant balloon and SeQuent® Please drug coated balloon (DCB)
| Study group | Role | What they receive |
|---|---|---|
| Non-slip element balloon (NSE) | Active comparator | Lacrosse® NSE dilatation before use of SeQuent® Please drug coated balloon (DCB) Receives: Device: Non-slip element balloon (NSE) |
| Balloon | Placebo comparator | Non-compliant balloon dilatation before use of SeQuent® Please drug coated balloon (DCB) Receives: Device: Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angiographic in-segment late loss
Measured: 8 months
Secondary outcomes (8)
angiographic minimal lumen diameter
Measured: 8 months
minimal lumen area (OCT analysis)
Measured: within one day
mean neointimal area (OCT analysis)
Measured: within one day
angiographic acute gain
Measured: within one day
Target vessel failure
cardiac death, myocardial infarction, target vessel revascularization
Measured: 8 months and 24 months
the prevalence of stent implantation
Measured: within one day
the prevalence of balloon slipping
more than 3 mm balloon slipping
Measured: within one day
DCB length
Measured: within one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2014 (estimated)
- Study startJun 2015
- Primary completionApr 2018 (estimated)
- Study completionApr 2019 (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 Coronary RestenosisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mitsui Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Teikyo University, Tokai University
- Responsible party
- Principal investigator, Jiro Aoki, Mitsui Memorial Hospital
- Investigators
- Ai Teramoto, Study director, Teikyo Academic Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02300454
- Sponsor's protocol ID
- MEC2014-14
- Acronym
- ELEGANT
- Status last verified
- Mar 2017
- First submitted
- 14 Nov 2014
- Last updated
- 23 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Aoki J, Nakazawa G, Ando K, Nakamura S, Tobaru T, Sakurada M, Okada H, Hibi K, Zen K, Ikuta A, Fujii K, Habara M, Ako J, Asano T, Ozaki S, Fusazaki T, Kozuma K; ELEGANT investigators. Impact of hemodialysis on clinical and angiographic outcomes in in-stent restenotic lesions following optical coherence tomography-guided drug-coated balloon treatment. Cardiovasc Interv Ther. 2021 Oct;36(4):429-435. doi: 10.1007/s12928-020-00718-7. Epub 2020 Oct 13.
PubMed 33048289
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Combination of Non-sLip Element Balloon (NSE) and druG-coated bAlloon (DCB) for In-steNT Restenosis Lesions
- ClinicalTrials.gov ID
- NCT02300454
- Acronym / sponsor ID
- ELEGANT / MEC2014-14
- Conditions
- Coronary Restenosis
- Keywords
- in-stent restenosis, percutaneous coronary intervention, balloon
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Mitsui Memorial HospitalUniversity, hospital or other
- Collaborators
- Teikyo University, Tokai University
- Study start
- Jun 2015
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 25 Nov 2014 (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.
Use of SeQuent® Please drug coated balloon (DCB) is effective to treat patients with in-stent restenosis (ISR). However, whether the type of pre-dilatation balloon prior to DCB dilatation impacts on clinical and angiographic outcomes or not is unknown. Lacrosse® Non-slip element balloon (NSE) is a balloon catheter with 3 longitudinal plastic elements which are attached to proximal and distal balloon edges. NSE is developed to incise neointimal tissue and avoid balloon slippage without vitiating balloon derivability and crossability. We investigated angiographic and clinical outcomes following normal non-compliant balloon or NSE dilatation prior to DCB dilatation in ISR lesions.This study is a single blinded, multicenter, randomized trial. Total 200 patients with ISR are randomly assigned to treat with non-compliant balloon or NSE before DCB dilatation. Optical coherence tomographic (OCT) analysis are performed before pre-dilatation and after DCB dilatation Follow-up angiography analysis are planned at 8 months in all patients. Clinical follow-up is planned at 8 and 24 months.Primary endpoint is angiographic in-segment late loss at 8 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-slip element balloon (NSE) | Active comparator | Device: Non-slip element balloon (NSE)Lacrosse® NSE dilatation before use of SeQuent® Please drug coated balloon (DCB) |
| Balloon | Placebo comparator | Device: BalloonNon-compliant balloon dilatation before use of SeQuent® Please drug coated balloon (DCB) |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with in-stent restenosis lesions who are planned to be treated with drug coating balloon
Key exclusion criteria (6 listed)
- ST elevation myocardial infarction
- stent thrombosis
- severe renal dysfunction (eGFR <30 ml/min) except dialysis
- pregnancy
- planned surgery within 3 months
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 |
|---|---|---|
| Non-slip element balloon (NSE)Lacrosse® NSE and SeQuent® Please drug coated balloon (DCB) | Device | Non-slip element balloon (NSE) |
| BalloonNon-compliant balloon and SeQuent® Please drug coated balloon (DCB) | Device | Balloon |
Primary outcome
Angiographic in-segment late loss
Time frame: 8 months
8 secondary outcomes
angiographic minimal lumen diameter
Time frame: 8 months
minimal lumen area (OCT analysis)
Time frame: within one day
mean neointimal area (OCT analysis)
Time frame: within one day
angiographic acute gain
Time frame: within one day
Target vessel failure
Time frame: 8 months and 24 months
the prevalence of stent implantation
Time frame: within one day
the prevalence of balloon slipping
Time frame: within one day
DCB length
Time frame: within one day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2017.
- Derived from this study: PubMed 33048289Aoki J, Nakazawa G, Ando K, Nakamura S, Tobaru T, Sakurada M, Okada H, Hibi K, Zen K, Ikuta A, Fujii K, Habara M, Ako J, Asano T, Ozaki S, Fusazaki T, Kozuma K; ELEGANT investigators. Impact of hemodialysis on clinical and angiographic outcomes in in-stent restenotic lesions following optical coherence tomography-guided drug-coated balloon treatment. Cardiovasc Interv Ther. 2021 Oct;36(4):429-435. doi: 10.1007/s12928-020-00718-7. Epub 2020 Oct 13.
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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.
Ai Teramoto study director
Teikyo Academic Research Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Non-slip element balloon (NSE) and Balloon in people with Coronary Restenosis, run by Mitsui Memorial Hospital at 2 sites in Japan.
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 1 inclusion and 6 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 23 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. 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. Some participants in this study may receive a placebo. 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?
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?
Angiographic in-segment late loss (time frame: 8 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 NCT02300454, 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 23 Mar 2017.