Diffuse Type In-Stent Restenosis After Drug-Eluting Stent - Full Text View

Sponsored by:	CardioVascular Research Foundation, Korea
Information provided by:	CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier:	NCT00485030

Purpose

To evaluate the best therapeutic option for the treatment of diffuse type post-drug-eluting stent restenosis.

Condition	Intervention	Phase
In-Stent Restenosis	Device: Sirolimus-eluting stent (cypher, J&J, Cordis) Device: Paclitaxel-eluting stent (Taxus liberte, Boston Scientific)	Phase IV

Drug Information available for: Paclitaxel Sirolimus

U.S. FDA Resources

Study Type:

Interventional

Study Design:

Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:

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

Further study details as provided by CardioVascular Research Foundation, Korea:

Primary Outcome Measures:

Binary in-segment angiographic restenosis [ Time Frame: at 9 months angiographic follow-up ]

Secondary Outcome Measures:

The composite of death, myocardial infarction, and target-vessel revascularization [ Time Frame: in-hospital, 1 month, and 9 months after index procedure ]
stent thrombosis [ Time Frame: in-hospital, 1 month, and 9 months after index procedure ]
Late luminal loss [ Time Frame: at 8 month angiographic follow-up ]
• 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 ]

Estimated Enrollment:	200
Study Start Date:	March 2007
Estimated Study Completion Date:	June 2009

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00485030

Contacts

Contact: Seung-Jung Park, MD, PhD	2-3010-4812 ext 82	sjpark@amc.seoul.kr
Contact: Duk-Woo Park, MD, PhD	2-3010-3995 ext 82	dwpark@amc.seoul.kr

Locations

Korea, Republic of
Asan Medical Center	Recruiting
GangNeung, Korea, Republic of
Contact: Sang-Sig Cheong, MD, PhD
Principal Investigator: Sang-Sig Cheong, MD, PhD
Asan Medical Center	Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Seung-Jung Park, MD, PhD (82-2)-3010-4812 sjpark@amc.seoul.kr
Contact: Duk-Woo Park, MD, PhD (82-2)-3010-3995 dwpark@amc.seoul.kr
Principal Investigator: Seung-Jung Park, MD, PhD
Choeng Ju St.Mary’s Hospital	Recruiting
Choeng Ju, Korea, Republic of
Contact: Yong-Mo Yang, MD, PhD
Principal Investigator: Yong-Mo Yang, MD, PhD
Chonbuk National University Hospital	Recruiting
Jeonju, Korea, Republic of
Contact: Jae-Ki Ko, MD, PhD
Principal Investigator: Jae-Ki Ko, MD, PhD
DongGuk University Gyongju Hospital	Recruiting
Gyongju, Korea, Republic of
Contact: Deuk Young Nah, MD, PhD
Principal Investigator: Deuk Young Nah, MD, PhD
Hallym University Sacred Heart Hospital,	Recruiting
PyeongChon, Korea, Republic of
Contact: Young-Jin Choi, MD, PhD
Principal Investigator: Young-Jin Choi, MD, PhD
Hallym University Sacred Heart Hospital	Recruiting
PyeongChon, Korea, Republic of
Contact: Young-Jin Choi, MD, PhD
Principal Investigator: Young-Jin Choi, MD, PhD
Ulsan University Hospital	Recruiting
Ulsan, Korea, Republic of
Contact: Sang-Gon Lee, MD, PhD
Principal Investigator: Sang-Gon Lee, MD, PhD
Inje University Pusan Paik Hospital	Recruiting
Pusan, Korea, Republic of
Contact: DongSoo Kim, MD, PhD
Principal Investigator: Dong Soo Kim, MD, PhD
Kangwon National University Hospital	Recruiting
Chuncheon, Korea, Republic of
Contact: Byoung Ryul Cho, MD, PhD
Principal Investigator: Byung Ryul Cho, MD, PhD
Kwangju Christian Hospital	Recruiting
Kwangju, Korea, Republic of
Contact: Seung-Wook Lee, MD, PhD
Principal Investigator: Seung-Wook Lee, MD, PhD
Kyungsang University Hospital	Recruiting
Seoul, Korea, Republic of
Contact: Chung-Whan Kwak, MD, PhD
Seoul Veterans Hospital	Recruiting
Seoul, Korea, Republic of
Contact: Keun Lee, MD, PhD
Principal Investigator: Keun Lee, MD, PhD
Soonchunhyang University Bucheon Hospital	Recruiting
Bucheon, Korea, Republic of
Contact: Nae-Hee Lee, MD, PhD
Principal Investigator: Nae-Hee Lee, MD, PhD
Hangang Sacred Heart Hospital	Recruiting
Seoul, Korea, Republic of
Contact: Wo Jung Park, MD, PhD
Principal Investigator: Woo Jung Park, MD, PhD

Sponsors and Collaborators

CardioVascular Research Foundation, Korea

Investigators

Principal Investigator:

Seung-Jung Park, MD, PhD

Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine

More Information

No publications provided

Study ID Numbers:	20070044
Study First Received:	June 11, 2007
Last Updated:	June 11, 2007
ClinicalTrials.gov Identifier:	NCT00485030 History of Changes
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by CardioVascular Research Foundation, Korea:

coronary artery disease
stent
angioplasty

Study placed in the following topic categories:

Sirolimus
Immunologic Factors
Clotrimazole
Miconazole
Tioconazole
Antimitotic Agents
Immunosuppressive Agents

Coronary Disease
Anti-Bacterial Agents
Paclitaxel
Antifungal Agents
Tubulin Modulators
Antineoplastic Agents, Phytogenic
Coronary Artery Disease

Additional relevant MeSH terms:

Sirolimus
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Mitosis Modulators
Physiological Effects of Drugs
Antimitotic Agents
Antibiotics, Antineoplastic

Immunosuppressive Agents
Pharmacologic Actions
Anti-Bacterial Agents
Paclitaxel
Therapeutic Uses
Antifungal Agents
Tubulin Modulators
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 07, 2009