Focal In-stent Restenosis After Drug-Eluting Stent

NCT00485004 | Completed Phase 4 DMC

• 1 other identifier: 20070041
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 15

Brief Summary

To evaluate the optimal management of focal in-stent restenosis after drug-eluting stent implantation with sirolimus-eluting implantation versus cutting balloon angioplasty

Conditions

In Stent Restenosis

Keywords

Coronary artery disease; Stent; Angioplasty

Outcome Measures

Primary Outcomes (1)

• Binary In-segment Restenosis

  At 9 months angiographic follow-up

Secondary Outcomes (4)

• Composite end-point of death, myocardial infarction, or target vessel revascularization

  At 9-month after index procedure

• Stent thrombosis

  In-hospital, 30 days, 9 months, and 1year

• Late luminal loss

  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

  during the hospital stay

Study Arms (2)

Cutting balloon

EXPERIMENTAL

Cutting balloon

Device: Cutting balloon; Device: Sirolimus-eluting stent

Sirolimus-eluting stent

ACTIVE COMPARATOR

Sirolimus-eluting stent

Device: Cutting balloon; Device: Sirolimus-eluting stent

Interventions

Cutting balloon DEVICE

Cutting balloon

Cutting balloon; Sirolimus-eluting stent

Sirolimus-eluting stent DEVICE

Sirolimus-eluting stent

Cutting balloon; Sirolimus-eluting stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient must be at least 18 years of age.
• Restenosis after drug-eluting stents (\>50% by visual estimate)
• Lesion length \< 10 mm (focal 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.

You may not qualify if:

• 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%.

Sponsors & Collaborators

• Seung-Jung Park: lead
• CardioVascular Research Foundation, Korea: collaborator

Study Sites (15)

Soonchunhyang University Bucheon Hospital

Bucheon-si, South Korea

Location

Choeng Ju St.Mary's Hospital

Choeng Ju, South Korea

Location

Kangwon National University Hospital

Chuncheon, South Korea

Location

Chungnam National University Hospital

Daejeon, South Korea

Location

Asan Medical Center

Gangneung, South Korea

Location

DongGuk University Gyongju Hospital

Gyongju, South Korea

Location

Chonbuk National University Hospital

Jeonju, South Korea

Location

Kwangju Christian Hospital

Kwangju, South Korea

Location

Inje University Pusan Paik Hospital

Pusan, South Korea

Location

Hallym University Sacred Heart Hospital,

Pyeongchon, South Korea

Location

Asan Medical Center

Seoul, 138-736, South Korea

Location

Hangang Sacred Heart Hospital

Seoul, South Korea

Location

Kyungsang University Hospital

Seoul, South Korea

Location

Seoul Veterans Hospital

Seoul, South Korea

Location

Ulsan University Hospital

Ulsan, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Seung-Jung Park, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine

Study Record Dates

• First Submitted: June 11, 2007
• First Posted: June 12, 2007
• Study Start: March 1, 2007
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: August 8, 2012

Record last verified: 2012-08

Locations

KR (15)