- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00485030
Diffuse Type In-Stent Restenosis After Drug-Eluting Stent (DES-ISR)
August 6, 2012 updated by: Seung-Jung Park
Comparison Between Drug-Eluting Stents for the Treatment of the Diffuse Type In-Stent Restenosis After Drug-Eluting Stents Implantation: Sirolimus-Eluting vs. Paclitaxel-Eluting Stents
To evaluate the best therapeutic option for the treatment of diffuse type post-drug-eluting stent restenosis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Despite a significant reduction of angiographic restenosis and the need for repeat revascularization after introduction of DES, post-DES restenosis still occur and the treatment for DES failure is challenging.
However, there have been little data for therapeutic strategy for post-DES restenosis, especially diffuse type ISR.
Therefore, we need the well-designed randomized trial to achieve the best therapeutic option for the treatment of diffuse type post-DES restenosis.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Bucheon, Korea, Republic of
- SoonChunHyang University Bucheon Hospital
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Choeng Ju, Korea, Republic of
- Choeng Ju St.Mary's Hospital
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Chuncheon, Korea, Republic of
- Kangwon National University Hospital
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GangNeung, Korea, Republic of
- Asan Medical Center
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Gyongju, Korea, Republic of
- DongGuk University Gyongju Hospital
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Jeonju, Korea, Republic of
- Chonbuk National University Hospital
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Kwangju, Korea, Republic of
- Kwangju Christian Hospital
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Pusan, Korea, Republic of
- Inje University Pusan Paik Hospital
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PyeongChon, Korea, Republic of
- Hallym University Sacred Heart Hospital,
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PyeongChon, Korea, Republic of
- Hallym University Sacred Heart Hospital
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Seoul, Korea, Republic of, 138-736
- Asan Medical Center
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Seoul, Korea, Republic of
- Hangang Sacred Heart Hospital
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Seoul, Korea, Republic of
- Seoul Veterans Hospital
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Seoul, Korea, Republic of
- Kyungsang University Hospital
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Ulsan, Korea, Republic of
- Ulsan University Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- The patient must be at least 18 years of age.
- Restenosis after drug-eluting stents (>50% by visual estimate)
- Lesion length ≥ 10 mm (diffuse type ISR)
- Patients with stable (CCS class 1 to 4) or acute coronary syndromes (unstable angina pectoris Braunwald class IB, IC, IIB, IIC, IIIB, IIIC or NSTEMI) or patients with atypical chest pain or without symptoms but having documented myocardial ischemia, amenable to stent-assisted percutaneous coronary intervention
- 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) Sirolimus 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.
- History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
- Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
- Current known current platelet count <100,000 cells/mm3 or Hgb <10 g/dL.
- 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.
- Patients with EF<30%.
- Acute MI patients within symptom onset < 12 hours needing primary angioplasty
- Creatinine level 3.0mg/dL or dependence on dialysis.
- Severe hepatic dysfunction (AST and ALT 3 times upper normal reference values).
- Patients with left main stem stenosis and left main in-stent restenosis created by DES(>50% by visual estimate)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cypher
sirolimus-eluting stent
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sirolimus-eluting stent
Other Names:
everolimus-eluting stent
Other Names:
|
Active Comparator: Xience-V
everolimus-eluting stent
|
sirolimus-eluting stent
Other Names:
everolimus-eluting stent
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Binary in-segment angiographic restenosis
Time Frame: at 9 months angiographic follow-up
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at 9 months angiographic follow-up
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Procedural success defined as achievement of a final diameter stenosis of <30% by QCA using any percutaneous method, without the occurrence of death, Q wave MI, or repeat revascularization of the target lesion
Time Frame: during the hospital stay
|
during the hospital stay
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Late luminal loss
Time Frame: at 8 month angiographic follow-up
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at 8 month angiographic follow-up
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The composite of death, myocardial infarction, and target-vessel revascularization
Time Frame: in-hospital, 1 month, and 9 months after index procedure
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in-hospital, 1 month, and 9 months after index procedure
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stent thrombosis
Time Frame: in-hospital, 1 month, and 9 months after index procedure
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in-hospital, 1 month, and 9 months after index procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2007
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
October 1, 2011
Study Registration Dates
First Submitted
June 11, 2007
First Submitted That Met QC Criteria
June 11, 2007
First Posted (Estimate)
June 12, 2007
Study Record Updates
Last Update Posted (Estimate)
August 8, 2012
Last Update Submitted That Met QC Criteria
August 6, 2012
Last Verified
August 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20070044
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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