Drug-eluting Stents vs. Drug-coated Balloon for Preventing Recurrent In-stent Restenosis
RESTORE
Treatment of Drug-Eluting Stent REstenosis Using Drug-Eluting STents vs. Drug-COated Balloon for Preventing REcurrent In-Stent Restenosis
1 other identifier
interventional
175
1 country
11
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Apr 2013
Longer than P75 for phase_4
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 18, 2013
CompletedFirst Submitted
Initial submission to the registry
October 17, 2013
CompletedFirst Posted
Study publicly available on registry
October 22, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 14, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 14, 2017
CompletedFebruary 24, 2017
February 1, 2017
3.8 years
October 17, 2013
February 23, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Late luminal loss
Late luminal loss at 9 months angiographic follow-up.
9months
Secondary Outcomes (7)
Death
1 year
Myocardial infarction
1 year
Target lesion revascularization
1 year
Target vessel revascularization
1 year
Stent thrombosis
1 year
- +2 more secondary outcomes
Study Arms (2)
Drug Eluting Stent
ACTIVE COMPARATOREverolimus-eluting balloon expandable stent (Xience Prime or Xience Xpedition or Xience Alpine)
paclitaxel eluting balloon
EXPERIMENTALpaclitaxel eluting balloon (SeQuent Please)
Interventions
Everolimus-eluting balloon expandable stent (Xience Prime or Xience Xpedition or Xience Alpine)
paclitaxel eluting balloon (SeQuent Please)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seung-Jung Parklead
- CardioVascular Research Foundation, Koreacollaborator
Study Sites (11)
Asan Medical Center
Seoul, Songpa-gu, 138-736, South Korea
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, South Korea
Chungbuk National University Hospital
Chungjoo, South Korea
Daegu Catholic University Medical Center
Daegu, South Korea
Keimyung University Dongsan Medical Center
Daegu, South Korea
The Catholic University of Korea, Daejeon ST. Mary's Hospital
Daejeon, South Korea
Chonnam National University Hospital
Gwangju, South Korea
National Health Insurance Service Ilsan Hospital
Ilsan, South Korea
Dong-A Medical Center
Pusan, South Korea
Seoul National University Boramae Medical Center
Seoul, South Korea
Ulsan University Hospital
Ulsan, South Korea
Related Publications (1)
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.
PMID: 29447782DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- M.D, Ph.D.
Study Record Dates
First Submitted
October 17, 2013
First Posted
October 22, 2013
Study Start
April 18, 2013
Primary Completion
February 14, 2017
Study Completion
February 14, 2017
Last Updated
February 24, 2017
Record last verified: 2017-02