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

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ClinicalTrials.gov Identifier: NCT01967199
Recruitment Status : Terminated
First Posted : October 22, 2013
Last Update Posted : February 24, 2017
Sponsor:
Collaborator:
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Seung-Jung Park, Asan Medical Center

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.

Condition or disease Intervention/treatment Phase
Coronary Restenosis Device: Everolimus-eluting balloon expandable stent Device: paclitaxel eluting balloon Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 175 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Drug-Eluting Stent REstenosis Using Drug-Eluting STents vs. Drug-COated Balloon for Preventing REcurrent In-Stent Restenosis
Actual Study Start Date : April 18, 2013
Actual Primary Completion Date : February 14, 2017
Actual Study Completion Date : February 14, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Drug Eluting Stent
Everolimus-eluting balloon expandable stent (Xience Prime or Xience Xpedition or Xience Alpine)
Device: Everolimus-eluting balloon expandable stent
Everolimus-eluting balloon expandable stent (Xience Prime or Xience Xpedition or Xience Alpine)

Experimental: paclitaxel eluting balloon
paclitaxel eluting balloon (SeQuent Please)
Device: paclitaxel eluting balloon
paclitaxel eluting balloon (SeQuent Please)




Primary Outcome Measures :
  1. Late luminal loss [ Time Frame: 9months ]
    Late luminal loss at 9 months angiographic follow-up.


Secondary Outcome Measures :
  1. Death [ Time Frame: 1 year ]
  2. Myocardial infarction [ Time Frame: 1 year ]
  3. Target lesion revascularization [ Time Frame: 1 year ]
  4. Target vessel revascularization [ Time Frame: 1 year ]
  5. Stent thrombosis [ Time Frame: 1 year ]
  6. In-segment or in-stent restenosis at 9 month angiographic follow-up [ Time Frame: 1 year ]
  7. Procedural success [ Time Frame: 3day ]

    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.




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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01967199


Locations
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Korea, Republic of
Asan Medical Center
Seoul, Songpa-gu, Korea, Republic of, 138-736
Soon Chun Hyang University Hospital Bucheon
Bucheon, Korea, Republic of
Chungbuk National University Hospital
Chungjoo, Korea, Republic of
Daegu Catholic University Medical Center
Daegu, Korea, Republic of
Keimyung University Dongsan Medical Center
Daegu, Korea, Republic of
The Catholic University of Korea, Daejeon ST. Mary's Hospital
Daejeon, Korea, Republic of
Chonnam National University Hospital
Gwangju, Korea, Republic of
National Health Insurance Service Ilsan Hospital
Ilsan, Korea, Republic of
Dong-A Medical Center
Pusan, Korea, Republic of
Seoul National University Boramae Medical Center
Seoul, Korea, Republic of
Ulsan University Hospital
Ulsan, Korea, Republic of
Sponsors and Collaborators
Seung-Jung Park
CardioVascular Research Foundation, Korea

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Seung-Jung Park, M.D, Ph.D., Asan Medical Center
ClinicalTrials.gov Identifier: NCT01967199     History of Changes
Other Study ID Numbers: AMCCV2013-01
First Posted: October 22, 2013    Key Record Dates
Last Update Posted: February 24, 2017
Last Verified: February 2017

Keywords provided by Seung-Jung Park, Asan Medical Center:
drug-eluting stent
drug-coated Balloon
recurrent In-Stent restenosis

Additional relevant MeSH terms:
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Coronary Restenosis
Coronary Stenosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Sirolimus
Paclitaxel
Albumin-Bound Paclitaxel
Everolimus
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents