Comparison of Cilotax Stent and Everolimus -Eluting Stent With Diabetes Mellitus (ESSENCE-DM III)

Coronary Artery Disease Clinical Trial

Official title:

Randomized Comparison of Dual Drug-Eluting Cilotax Stent and Everolimus -Eluting Stent Implantation for DE Novo Coronary Artery DisEase in Patients With DIABETES Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01515228
• Other study ID #: CVRF2011-11
• Status: Completed
• Phase: Phase 4
• First received: January 18, 2012
• Last updated: January 8, 2015
• Start date: January 2012
• Est. completion date: January 2015

Study information

• Verified date: January 2015
• Source: CardioVascular Research Foundation, Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to examine the safety and effectiveness of coronary stenting with the Cilotax stent compared to the Xience Prime stent in the treatment of diabetic patients.

Description:

Prospective, randomized multi-center trial of 300 patients will be enrolled at 7 centers in Korea. Following angiography, diabetic patients with significant diameter stenosis >50% by visual estimation have documented myocardial ischemia or symptoms of angina, and eligible for stenting without any exclusion criteria will be randomized 1:1 to: a) Cilotax stent vs. b) Xience Prime stent. All patients will be followed for at least 1 year. Angiographic follow-up at 9-months is routinely recommended.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 291
• Est. completion date: January 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 74 Years

Eligibility

Inclusion Criteria:

Clinical:

• Diabetic patients with active treatment (oral agent or insulin)

• Patients with angina and documented ischemia or patients with documented silent ischemia

• Patients who are eligible for intracoronary stenting

• Age > 20 years, < 75 years

Angiographic:

• De novo lesion

• Percent diameter stenosis = 50%

• Reference vessel size = 2.5 mm by visual estimation

Exclusion Criteria:

1. History of bleeding diathesis or coagulopathy

2. Pregnant state

3. Known hypersensitivity or contra-indication to contrast agent and heparin

4. Limited life-expectancy (less than 1 year)

5. ST-elevation acute myocardial infraction requiring primary stenting

6. Characteristics of lesion: left main disease, in-stent restenosis, graft vessels

7. Hematological disease (Neutropenia < 3000/mm3), Thrombocytopenia < 100,000/mm3)

8. Hepatic dysfunction, liver enzyme (ALT and AST) elevation = 3times normal

9. Renal dysfunction, creatinine = 2.0mg/dL

10. Contraindication to aspirin, clopidogrel or cilostazol

11. Contraindication to Paclitaxel or everolimus

12. Left ventricular ejection fraction < 30%

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

14. 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 for example: oxygen dependent chronic obstructive pulmonary disease, active hepatitis or severe liver function or kidney disease)

Study Design

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Diabetes Mellitus
• Myocardial Ischemia

Intervention

Device:
• Xience Prime
everolimus-eluting stent implantation
• Cilotax stent
paclitaxel with cilostazol dual drug eluting stent implantation

Locations

Country	Name	City	State
Korea, Republic of	Soon Chun Hyang University Hospital Cheonan	Cheonan
Korea, Republic of	Daegu Catholic University Medical Center	Daegu
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	The Catholic University of Korea, Daejeon ST. Mary's Hospital	Daejeon
Korea, Republic of	Gangneung Asan Hospital	Gangneung
Korea, Republic of	Inje University Pusan Paik Hospital	Pusan
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Ulsan University Hospital	Ulsan

Sponsors (2)

Lead Sponsor	Collaborator
CHEOL WHAN LEE, MD, PhD.	CardioVascular Research Foundation, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-segment late luminal loss		at 9 month angiographic follow-up	No
Secondary	All Death		12 months	Yes
Secondary	Cardiac death		12 months	Yes
Secondary	Myocardial infarction		12 months	Yes
Secondary	Target vessel revascularization (ischemia-driven)		12 months	No
Secondary	Target lesion revascularization (ischemia-driven)		12 months	No
Secondary	Stent thrombosis (by ARC definition)		12 months	Yes
Secondary	Binary restenosis in both in-stent and in-segment		at 9 month angiographic follow-up	No
Secondary	Angiographic pattern of restenosis		at 9 month angiographic follow-up	No
Secondary	Procedural success	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	At discharge from the index hospitalization, an expected average of 3 days.	No
Secondary	All Death		1 month	Yes
Secondary	All Death		4 months	Yes
Secondary	All Death		9 months	Yes
Secondary	Cardiac death		1 month	Yes
Secondary	Cardiac death		4 months	Yes
Secondary	Cardiac death		9 months	Yes
Secondary	Myocardial infarction		1 month	Yes
Secondary	Myocardial infarction		4 months	Yes
Secondary	Myocardial infarction		9 months	Yes
Secondary	Target vessel revascularization (ischemia-driven)		1 month	No
Secondary	Target vessel revascularization (ischemia-driven)		4 months	No
Secondary	Target vessel revascularization (ischemia-driven)		9 months	No
Secondary	Target lesion revascularization (ischemia-driven)		1 month	No
Secondary	Target lesion revascularization (ischemia-driven)		4 months	No
Secondary	Target lesion revascularization (ischemia-driven)		9 months	No
Secondary	Stent thrombosis (by ARC definition)		1 month	Yes
Secondary	Stent thrombosis (by ARC definition)		4 months	Yes
Secondary	Stent thrombosis (by ARC definition)		9 months	Yes