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Drug-eluting Stents vs. Drug-coated Balloon for Preventing Recurrent In-stent Restenosis (RESTORE)

Primary Purpose

Coronary Restenosis

Status
Terminated
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Everolimus-eluting balloon expandable stent
paclitaxel eluting balloon
Sponsored by
Seung-Jung Park
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Restenosis focused on measuring drug-eluting stent, drug-coated Balloon, recurrent In-Stent restenosis

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • Asan Medical Center
  • Soon Chun Hyang University Hospital Bucheon
  • Chungbuk National University Hospital
  • Daegu Catholic University Medical Center
  • Keimyung University Dongsan Medical Center
  • The Catholic University of Korea, Daejeon ST. Mary's Hospital
  • Chonnam National University Hospital
  • National Health Insurance Service Ilsan Hospital
  • Dong-A Medical Center
  • Seoul National University Boramae Medical Center
  • Ulsan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Drug Eluting Stent

paclitaxel eluting balloon

Arm Description

Everolimus-eluting balloon expandable stent (Xience Prime or Xience Xpedition or Xience Alpine)

paclitaxel eluting balloon (SeQuent Please)

Outcomes

Primary Outcome Measures

Late luminal loss
Late luminal loss at 9 months angiographic follow-up.

Secondary Outcome Measures

Death
Myocardial infarction
Target lesion revascularization
Target vessel revascularization
Stent thrombosis
In-segment or in-stent restenosis at 9 month angiographic follow-up
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.

Full Information

First Posted
October 17, 2013
Last Updated
February 23, 2017
Sponsor
Seung-Jung Park
Collaborators
CardioVascular Research Foundation, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT01967199
Brief Title
Drug-eluting Stents vs. Drug-coated Balloon for Preventing Recurrent In-stent Restenosis
Acronym
RESTORE
Official Title
Treatment of Drug-Eluting Stent REstenosis Using Drug-Eluting STents vs. Drug-COated Balloon for Preventing REcurrent In-Stent Restenosis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Study Start Date
April 18, 2013 (Actual)
Primary Completion Date
February 14, 2017 (Actual)
Study Completion Date
February 14, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Seung-Jung Park
Collaborators
CardioVascular Research Foundation, Korea

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Restenosis
Keywords
drug-eluting stent, drug-coated Balloon, recurrent In-Stent restenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
175 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Drug Eluting Stent
Arm Type
Active Comparator
Arm Description
Everolimus-eluting balloon expandable stent (Xience Prime or Xience Xpedition or Xience Alpine)
Arm Title
paclitaxel eluting balloon
Arm Type
Experimental
Arm Description
paclitaxel eluting balloon (SeQuent Please)
Intervention Type
Device
Intervention Name(s)
Everolimus-eluting balloon expandable stent
Intervention Description
Everolimus-eluting balloon expandable stent (Xience Prime or Xience Xpedition or Xience Alpine)
Intervention Type
Device
Intervention Name(s)
paclitaxel eluting balloon
Intervention Description
paclitaxel eluting balloon (SeQuent Please)
Primary Outcome Measure Information:
Title
Late luminal loss
Description
Late luminal loss at 9 months angiographic follow-up.
Time Frame
9months
Secondary Outcome Measure Information:
Title
Death
Time Frame
1 year
Title
Myocardial infarction
Time Frame
1 year
Title
Target lesion revascularization
Time Frame
1 year
Title
Target vessel revascularization
Time Frame
1 year
Title
Stent thrombosis
Time Frame
1 year
Title
In-segment or in-stent restenosis at 9 month angiographic follow-up
Time Frame
1 year
Title
Procedural success
Description
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.
Time Frame
3day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
State/Province
Songpa-gu
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Soon Chun Hyang University Hospital Bucheon
City
Bucheon
Country
Korea, Republic of
Facility Name
Chungbuk National University Hospital
City
Chungjoo
Country
Korea, Republic of
Facility Name
Daegu Catholic University Medical Center
City
Daegu
Country
Korea, Republic of
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Daejeon ST. Mary's Hospital
City
Daejeon
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital
City
Gwangju
Country
Korea, Republic of
Facility Name
National Health Insurance Service Ilsan Hospital
City
Ilsan
Country
Korea, Republic of
Facility Name
Dong-A Medical Center
City
Pusan
Country
Korea, Republic of
Facility Name
Seoul National University Boramae Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Ulsan University Hospital
City
Ulsan
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
29447782
Citation
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.
Results Reference
derived

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Drug-eluting Stents vs. Drug-coated Balloon for Preventing Recurrent In-stent Restenosis

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