Double or Single Dose Sirolimus-Eluting Stents in Diabetic Patients With de Novo Coronary Artery Lesions - Full Text View

Sponsored by:	Cordis Corporation
Information provided by:	Cordis Corporation
ClinicalTrials.gov Identifier:	NCT00233714

Purpose

The main objective of this study is to assess safety and effectiveness of double dose sirolimus-eluting Bx VELOCITY stents in diabetic patients with a de novo native coronary lesion, as compared to single dose sirolimus-eluting Bx VELOCITY™ stents.

Condition	Intervention	Phase
Coronary Artery Disease	Device: CYPHER Sirolimus-Eluting Coronary Stent	Phase I Phase II

MedlinePlus related topics: Coronary Artery Disease

Drug Information available for: Sirolimus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized Feasibility Study of the Double Dose or Single Dose Sirolimus-Eluting BX VELOCITY Balloon-Expandable Stent for the Treatment of Diabetic Patients With de Novo Native Coronary Artery Lesions(3D)

Further study details as provided by Cordis Corporation:

Primary Outcome Measures:

The primary endpoint is in-stent late lumen loss as measured by QCA at 6 months post-procedure. [ Time Frame: 6 months post-procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Composite of Major Adverse Cardiac Events (MACE) defined as death, myocardial infarction (Q wave and non-Q wave), emergent bypass surgery, or repeat target lesion revascularization at 30 days, 6 months, 12 months and 2, 3, 4 and 5 years post-procedure. [ Time Frame: 30 days, 6 months, 12 months and 2, 3, 4 and 5 years post-procedure ] [ Designated as safety issue: Yes ]
Target lesion revascularization (TLR) and target vessel revascularization (TVR) at 30 days, 6 months, 12 months and 2, 3, 4 and 5 years post-procedure. [ Time Frame: 30 days, 6 months, 12 months and 2, 3, 4 and 5 years post-procedure ] [ Designated as safety issue: Yes ]
Target vessel failure (TVF) defined as cardiac death, myocardial infarction, or target vessel revascularization at 30 days, 6 months, 12 months and 2, 3, 4 and 5 years post-procedure. [ Time Frame: 30 days, 6 months, 12 months and 2, 3, 4 and 5 years post-procedure ] [ Designated as safety issue: Yes ]
Device success defined as achievement of a final residual diameter stenosis of <50% (by QCA), using the assigned device only. If QCA is not available, the visual estimate of diameter stenosis is used. [ Time Frame: During Index Procedure ] [ Designated as safety issue: Yes ]
Lesion success defined as the attainment of <50% residual stenosis (by QCA) using any percutaneous method. [ Time Frame: During Index Procedure ] [ Designated as safety issue: No ]
Procedure success defined as achievement of a final diameter stenosis of <50% (by QCA) using any percutaneous method, without the occurrence of death, MI, or repeat revascularization of the target lesion during the hospital stay. [ Time Frame: During the hospital stay ] [ Designated as safety issue: Yes ]
In-stent and in-lesion binary restenosis (> 50% diameter stenosis) as measured by QCA at 6 months and 2 years. [ Time Frame: 6 months and 2 years ] [ Designated as safety issue: Yes ]
In-stent and in-lesion mean percent diameter stenosis (%DS) and minimal lumen. diameter (MLD) measured by QCA post-procedure and at 6 months and 2 years. [ Time Frame: post-procedure and at 6 months and 2 years ] [ Designated as safety issue: Yes ]
In-lesion late lumen loss measured by QCA at 6 months and 2 years. [ Time Frame: 6 months and 2 years ] [ Designated as safety issue: Yes ]
Stent lumen and stent obstruction volume by intravascular ultrasound (IVUS) at post-procedure and 6 months and 2 years. [ Time Frame: post-procedure 6 months and 2 years. ] [ Designated as safety issue: Yes ]
Glycemic control as measured by HbA1c at baseline, 6, 12, and 24 months. [ Time Frame: baseline, 6, 12, and 24 months ] [ Designated as safety issue: Yes ]
C-reactive protein levels measured at baseline, 6, 12, and 24 months related to patient outcomes. [ Time Frame: baseline, 6, 12, and 24 months ] [ Designated as safety issue: Yes ]

Enrollment:	56
Study Start Date:	May 2003
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Single-dose Sirolimus-Eluting Coronary stent	Device: CYPHER Sirolimus-Eluting Coronary Stent Single dose Sirolimus-Eluting coronary stent
2: Active Comparator Double-dose Sirolimus-Eluting Coronary stent	Device: CYPHER Sirolimus-Eluting Coronary Stent Double-dose Sirolimus-Eluting coronary stent

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 minimum 18 years of age;
Patients must be previously diagnosed with diabetes with documented treatment with insulin, oral medications, or diet for a minimum of 3 months;
Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B&C, I-II-III) OR patients with documented silent ischemia;
Treatment of one lesion in a native coronary artery. The treated lesion will be the one with the highest % diameter stenosis by visual estimate. Additional study stents may be used for procedural complications such as dissections. Multivessel treatment is permissible in non-target vessels; however, additional lesions may only be treated with commercial stents. If other non-target lesions are treated with commercial stents during the index procedure, they must be successfully treated prior to the study lesion;
The target vessel is 2.5 mm and 3.5mm in diameter (visual estimate);
The target lesion is <30 mm in length (visual estimate) located in a native coronary artery;
Target lesion stenosis is >50% and <100% (TIMI I) (visual estimate);

Exclusion Criteria:

Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented total CK>2 times normal within the preceding 24 hours and the CK and CK-MB enzymes remains above normal at the time of treatment;
Patients admitted for treatment of diabetic ketoacidosis > 2 times in the past six months (Brittle Diabetics);
Ejection fraction 30%;
Impaired renal function (creatinine > 2.0 mg/dL);

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00233714

Locations

Brazil
Institute Dante Pazzanese of Cardiology
Sao Paolo, Brazil

Sponsors and Collaborators

Cordis Corporation

Investigators

Principal Investigator:

Jose E. Sousa, MD

Institute Dante Pazzanese of Cardiology

More Information

Publications of Results:

Costa R, Sousa JE, et al. The radomised study of the double dose versus single dose sirolimus-eluting stent for the treatment of diabetic patients with de novo coronary lesions. EuroInterv.2006;2:295-301

Hur SH, Ako J, Shimada Y, Tsujino I, Hassan AH, Abizaid A, Shiran A, Lewis BS, Guagliumi G, Cohen SA, Honda Y, Fitzgerald PJ, Sousa JE. Two-year intravascular ultrasound observations in diabetic patients treated with single and double dose sirolimus-eluting stents: results of the double dose diabetes (3D) study. J Invasive Cardiol. 2008 Aug;20(8):411-6.

Responsible Party:	Cordis ( Sid Cohen, MD, VP )
Study ID Numbers:	P03-6318
Study First Received:	October 4, 2005
Last Updated:	September 30, 2008
ClinicalTrials.gov Identifier:	NCT00233714
Health Authority:	Israel: Ministry of Health; Italy: Ministry of Health; Brazil: National Committee of Ethics in Research

Study placed in the following topic categories:

Sirolimus
Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Clotrimazole
Miconazole

Myocardial Ischemia
Tioconazole
Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:

Anti-Bacterial Agents
Anti-Infective Agents
Immunologic Factors
Antineoplastic Agents
Antifungal Agents
Therapeutic Uses

Physiological Effects of Drugs
Cardiovascular Diseases
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009