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Study 19 of 1004 for search of: | Korea, Republic of |
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Sponsored by: |
CardioVascular Research Foundation, Korea |
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Information provided by: | CardioVascular Research Foundation, Korea |
ClinicalTrials.gov Identifier: | NCT00485004 |
To evaluate the optimal management of focal in-stent restenosis after drug-eluting stent implantation with sirolimus-eluting implantation versus cutting balloon angioplasty
Condition | Intervention | Phase |
---|---|---|
In-Stent Restenosis |
Device: Sirolimus-eluting stent (cypher, J&J, Cordis) Device: Cutting balloon |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | FOcal Type In-Stent Restenosis After Drug-Eluting Stent Implantation Treated by CUtting Balloon Angioplasty Versus Sirolimus-Eluting Stent |
Estimated Enrollment: | 200 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | June 2009 |
Following angiography, patients with focal DES restenosis (lesion length ≤ 10mm) with diameter stenosis >50% by visual estimation have documented myocardial ischemia or symptoms of angina, and eligible for PCI without any exclusion criteria will be randomized 1:1 to: a) Cypher stent vs. b) Cutting balloon angioplasty. All patients will be followed for 1 year. Angiographic follow-up at 9-months is mandatory.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
4. 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 5. 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:
Contact: Seung-Jung Park, MD, PhD | 02-3010-4812 ext 82 | sjpark@amc.seoul.kr |
Contact: Duk-Woo Park, MD, PhD | 02-3010-3995 | dwpark@amc.seoul.kr |
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 | |
Chonbuk National University Hospital | Recruiting |
Jeonju, Korea, Republic of | |
Contact: Jae-Ki Ko, MD, PhD | |
Principal Investigator: Jae-Ki Ko, MD, PhD | |
Chungnam National University Hospital | Recruiting |
Daejeon, Korea, Republic of | |
Contact: In-Whan Seong, MD, PhD | |
Principal Investigator: In-Whan Seong, 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 | |
Soonchunhyang University Bucheon Hospital | Recruiting |
Bucheon, Korea, Republic of | |
Contact: Nae-Hee Lee, MD, PhD | |
Principal Investigator: Nae-Hee Lee, MD, PhD | |
Ulsan University Hospital | Recruiting |
Ulsan, Korea, Republic of | |
Contact: Sang-Gon Lee, MD, PhD | |
Principal Investigator: Sang-Gon Lee, MD, PhD | |
Kwangju Christian Hospital | Recruiting |
Kwangju, Korea, Republic of | |
Contact: Seung-Wook Lee, MD, PhD | |
Principal Investigator: Seung-Wook 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 | |
Kyungsang University Hospital | Recruiting |
Seoul, Korea, Republic of | |
Contact: Chung-Whan Kwak, MD, PhD | |
Hangang Sacred Heart Hospital | Recruiting |
Seoul, Korea, Republic of | |
Contact: Wo Jung Park, MD, PhD | |
Principal Investigator: Woo Jung Park, MD, PhD | |
Seoul Veterans Hospital | Recruiting |
Seoul, Korea, Republic of | |
Contact: Keun Lee, MD, PhD | |
Principal Investigator: Keun Lee, 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 | |
DongGuk University Gyongju Hospital | Recruiting |
Gyongju, Korea, Republic of | |
Contact: Deuk Young Nah, MD, PhD | |
Principal Investigator: Deuk Young Nah, MD, PhD | |
Kangwon National University Hospital | Recruiting |
Chuncheon, Korea, Republic of | |
Contact: Byoung Ryul Cho, MD, PhD | |
Principal Investigator: Byung Ryul Cho, MD, PhD |
Principal Investigator: | Seung-Jung Park, MD, PhD | Department of Medicine, Asan Medical Center, University of Ulsan College of Medicine |
Study ID Numbers: | 20070041 |
Study First Received: | June 11, 2007 |
Last Updated: | June 11, 2007 |
ClinicalTrials.gov Identifier: | NCT00485004 |
Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
Coronary artery disease Stent Angioplasty |
Sirolimus Coronary Disease Clotrimazole |
Miconazole Tioconazole Coronary Artery Disease |
Anti-Bacterial Agents Anti-Infective Agents Immunologic Factors Antineoplastic Agents Antifungal Agents |
Therapeutic Uses Physiological Effects of Drugs Antibiotics, Antineoplastic Immunosuppressive Agents Pharmacologic Actions |