Coronary RestenosisPhase 4RESTORENCT01967199
Drug-eluting Stents vs. Drug-coated Balloon for Preventing Recurrent In-stent Restenosis
A Phase 4 study testing Everolimus-eluting balloon expandable stent and paclitaxel eluting balloon in people with Coronary Restenosis, run by Seung-Jung Park at 11 sites in South Korea.
Trial summary
The purpose of this study is to establish the safety and effectiveness of paclitaxel eluting balloon (SeQuent Please) compared to coronary stenting with the Everolimus-eluting balloon expandable stent (Xience Prime or Xience Xpedition or Xience Alpine) in the treatment of drug eluting stent restenosis. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Coronary Restenosis
- What is being tested?
- Everolimus-eluting balloon expandable stent and paclitaxel eluting balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 11 sitesSouth Korea
- Study dates
- 18 Apr 2013to 14 Feb 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must be more than or equal to 20 years of age
- Restenosis after drug-eluting stents (>50% by visual estimate)
- Any Lesion length including focal in stent restenosis or diffuse in stent restenosis
- The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
Who cannot join
- The patient has a known hypersensitivity or contraindication to any of the following medications:
- Heparin
- Aspirin
- Both Clopidogrel and TIclopidine
- Sirolimus eluting stent
- Stainless steel and/or
Show all 11Show fewer
- Contrast media (patients with documented sensitivity to contrast which can be effectively pre-medicated with steroids and diphenhydramine [e.g. rash] may be enrolled. Patients with true anaphylaxis to prior contrast media, however, should not be enrolled)
- Systemic (intravenous) Everolimus use within 12 months.
- Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study
- Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment)
- Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
South Korea11 sites
Soon Chun Hyang University Hospital Bucheon
Bucheon-si
Chungbuk National University Hospital
Chungjoo
Daegu Catholic University Medical Center
Daegu
Keimyung University Dongsan Medical Center
Daegu
The Catholic University of Korea, Daejeon ST. Mary's Hospital
Daejeon
Chonnam National University Hospital
Gwangju
National Health Insurance Service Ilsan Hospital
Ilsan
Dong-A Medical Center
Pusan
Asan Medical Center
Seoul, Songpa-gu, 138-736
Seoul National University Boramae Medical Center
Seoul
Ulsan University Hospital
Ulsan
About this study
Official title: Treatment of Drug-Eluting Stent REstenosis Using Drug-Eluting STents vs. Drug-COated Balloon for Preventing REcurrent In-Stent Restenosis
The purpose of this study is to establish the safety and effectiveness of paclitaxel eluting balloon (SeQuent Please) compared to coronary stenting with the Everolimus-eluting balloon expandable stent (Xience Prime or Xience Xpedition or Xience Alpine) in the treatment of drug eluting stent restenosis.
- Conditions
- Coronary Restenosis
- Being tested
- Everolimus-eluting balloon expandable stent, paclitaxel eluting balloon
- Keywords
- drug-eluting stent, drug-coated Balloon, recurrent In-Stent restenosis
- Medical subject headings
- Coronary Restenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Everolimus-eluting balloon expandable stentDevice
Everolimus-eluting balloon expandable stent (Xience Prime or Xience Xpedition or Xience Alpine)
paclitaxel eluting balloonDevice
paclitaxel eluting balloon (SeQuent Please)
| Study group | Role | What they receive |
|---|---|---|
| Drug Eluting Stent | Active comparator | Everolimus-eluting balloon expandable stent (Xience Prime or Xience Xpedition or Xience Alpine) Receives: Device: Everolimus-eluting balloon expandable stent |
| paclitaxel eluting balloon | Experimental | paclitaxel eluting balloon (SeQuent Please) Receives: Device: paclitaxel eluting balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Late luminal loss
Late luminal loss at 9 months angiographic follow-up.
Measured: 9months
Secondary outcomes (7)
Death
Measured: 1 year
Myocardial infarction
Measured: 1 year
Target lesion revascularization
Measured: 1 year
Target vessel revascularization
Measured: 1 year
Stent thrombosis
Measured: 1 year
In-segment or in-stent restenosis at 9 month angiographic follow-up
Measured: 1 year
Procedural success
defined as achievement of a final diameter stenosis of <30% by QCA(Quantitative Coronary Angiography) using any percutaneous method, without the occurrence of death, Q wave Myocardial Infarction, or repeat revascularization of the target lesion during the hospital stay.
participants will be followed for the duration of hospital stay, an expected average of 3days.
Measured: 3day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2013 (estimated)
- Study start18 Apr 2013
- Primary completion14 Feb 2017
- Study completion14 Feb 2017
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
- None (open label)
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seung-Jung Park
- Sponsor type
- University, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Responsible party
- Sponsor-investigator, Seung-Jung Park, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01967199
- Sponsor's protocol ID
- AMCCV2013-01
- Acronym
- RESTORE
- Status last verified
- Feb 2017
- First submitted
- 17 Oct 2013
- Last updated
- 24 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wong YTA, Kang DY, Lee JB, Rha SW, Hong YJ, Shin ES, Her SH, Nam CW, Chung WY, Kim MH, Lee CH, Lee PH, Ahn JM, Kang SJ, Lee SW, Kim YH, Lee CW, Park SW, Park DW, Park SJ. Comparison of drug-eluting stents and drug-coated balloon for the treatment of drug-eluting coronary stent restenosis: A randomized RESTORE trial. Am Heart J. 2018 Mar;197:35-42. doi: 10.1016/j.ahj.2017.11.008. Epub 2017 Nov 22.
PubMed 29447782
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Drug-Eluting Stent REstenosis Using Drug-Eluting STents vs. Drug-COated Balloon for Preventing REcurrent In-Stent Restenosis
- ClinicalTrials.gov ID
- NCT01967199
- Acronym / sponsor ID
- RESTORE / AMCCV2013-01
- Conditions
- Coronary Restenosis
- Keywords
- drug-eluting stent, drug-coated Balloon, recurrent In-Stent restenosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Seung-Jung ParkUniversity, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Study start
- 18 Apr 2013 (actual)
- Primary completion
- 14 Feb 2017 (actual)
- Study completion
- 14 Feb 2017 (actual)
- First posted
- 22 Oct 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 establish the safety and effectiveness of paclitaxel eluting balloon (SeQuent Please) compared to coronary stenting with the Everolimus-eluting balloon expandable stent (Xience Prime or Xience Xpedition or Xience Alpine) in the treatment of drug eluting stent restenosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug Eluting Stent | Active comparator | Device: Everolimus-eluting balloon expandable stentEverolimus-eluting balloon expandable stent (Xience Prime or Xience Xpedition or Xience Alpine) |
| paclitaxel eluting balloon | Experimental | Device: paclitaxel eluting balloonpaclitaxel eluting balloon (SeQuent Please) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patient must be more than or equal to 20 years of age
- Restenosis after drug-eluting stents (>50% by visual estimate)
- Any Lesion length including focal in stent restenosis or diffuse in stent restenosis
- The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
Key exclusion criteria (11 listed)
- The patient has a known hypersensitivity or contraindication to any of the following medications:
- Systemic (intravenous) Everolimus use within 12 months.
- Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study
- Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment)
- Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period
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 |
|---|---|---|
| Everolimus-eluting balloon expandable stentEverolimus-eluting balloon expandable stent (Xience Prime or Xience Xpedition or Xience Alpine) | Device | Drug Eluting Stent |
| paclitaxel eluting balloonpaclitaxel eluting balloon (SeQuent Please) | Device | paclitaxel eluting balloon |
Primary outcome
Late luminal loss
Time frame: 9months
Late luminal loss at 9 months angiographic follow-up.
7 secondary outcomes
Death
Time frame: 1 year
Myocardial infarction
Time frame: 1 year
Target lesion revascularization
Time frame: 1 year
Target vessel revascularization
Time frame: 1 year
Stent thrombosis
Time frame: 1 year
In-segment or in-stent restenosis at 9 month angiographic follow-up
Time frame: 1 year
Procedural success
Time frame: 3day
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2017.
- Derived from this study: PubMed 29447782Wong YTA, Kang DY, Lee JB, Rha SW, Hong YJ, Shin ES, Her SH, Nam CW, Chung WY, Kim MH, Lee CH, Lee PH, Ahn JM, Kang SJ, Lee SW, Kim YH, Lee CW, Park SW, Park DW, Park SJ. Comparison of drug-eluting stents and drug-coated balloon for the treatment of drug-eluting coronary stent restenosis: A randomized RESTORE trial. Am Heart J. 2018 Mar;197:35-42. doi: 10.1016/j.ahj.2017.11.008. Epub 2017 Nov 22.
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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.
The record lists no contact. Use the official record to reach the sponsor.
11 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 Everolimus-eluting balloon expandable stent and paclitaxel eluting balloon in people with Coronary Restenosis, run by Seung-Jung Park at 11 sites 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 11 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: stopped early, as of the sponsor's last update on 24 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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?
The study was stopped early. 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?
Late luminal loss (time frame: 9months). 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 NCT01967199, 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 24 Feb 2017.