Focal In-stent Restenosis After Drug-Eluting Stent

In Stent Restenosis Clinical Trial

— FOCUS  

Official title:

FOcal Type In-stent Restenosis After Drug-Eluting Stent Implantation Treated by CUtting Balloon Angioplasty Versus Sirolimus-Eluting Stent

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00485004
• Other study ID #: 20070041
• Status: Completed
• Phase: Phase 4
• First received: June 11, 2007
• Last updated: August 6, 2012
• Start date: March 2007
• Est. completion date: March 2011

Study information

• Verified date: August 2012
• Source: CardioVascular Research Foundation, Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. The patient must be at least 18 years of age.

2. Restenosis after drug-eluting stents (>50% by visual estimate)

3. Lesion length < 10 mm (focal ISR)

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:

1. 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).

2. Systemic (intravenous) Sirolimus use within 12 months.

3. Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.

4. History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.

5. Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.

6. Current known current platelet count <100,000 cells/mm3 or Hgb <10 g/dL.

7. 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).

8. Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.

9. Patients with EF<30%.

10. Acute MI patients within symptom onset < 12 hours needing primary angioplasty

11. Creatinine level 3.0mg/dL or dependence on dialysis.

12. Severe hepatic dysfunction (AST and ALT 3 times upper normal reference values).

13. Patients with left main stem stenosis and left main in-stent restenosis created by DES(>50% by visual estimate)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• In Stent Restenosis

Intervention

Device:
• Cutting balloon
Cutting balloon
• Sirolimus-eluting stent
Sirolimus-eluting stent

Locations

Country	Name	City	State
Korea, Republic of	Soonchunhyang University Bucheon Hospital	Bucheon
Korea, Republic of	Choeng Ju St.Mary's Hospital	Choeng Ju
Korea, Republic of	Kangwon National University Hospital	Chuncheon
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	Asan Medical Center	GangNeung
Korea, Republic of	DongGuk University Gyongju Hospital	Gyongju
Korea, Republic of	Chonbuk National University Hospital	Jeonju
Korea, Republic of	Kwangju Christian Hospital	Kwangju
Korea, Republic of	Inje University Pusan Paik Hospital	Pusan
Korea, Republic of	Hallym University Sacred Heart Hospital,	PyeongChon
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Hangang Sacred Heart Hospital	Seoul
Korea, Republic of	Kyungsang University Hospital	Seoul
Korea, Republic of	Seoul Veterans Hospital	Seoul
Korea, Republic of	Ulsan University Hospital	Ulsan

Sponsors (2)

Lead Sponsor	Collaborator
Seung-Jung Park	CardioVascular Research Foundation, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Binary In-segment Restenosis		At 9 months angiographic follow-up	No
Secondary	Composite end-point of death, myocardial infarction, or target vessel revascularization		At 9-month after index procedure	No
Secondary	Stent thrombosis		In-hospital, 30 days, 9 months, and 1year	Yes
Secondary	Late luminal loss		at 8 month angiographic follow-up	No
Secondary	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	No