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

NCT00233714 | Completed Phase 1

• 1 other identifier: P03-6318
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is in-stent late lumen loss as measured by QCA at 6 months post-procedure.

  6 months post-procedure

Secondary Outcomes (12)

• 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.

  30 days, 6 months, 12 months and 2, 3, 4 and 5 years post-procedure

• 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.

  30 days, 6 months, 12 months and 2, 3, 4 and 5 years post-procedure

• 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.

  30 days, 6 months, 12 months and 2, 3, 4 and 5 years post-procedure

• 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.

  During Index Procedure

• Lesion success defined as the attainment of <50% residual stenosis (by QCA) using any percutaneous method.

  During Index Procedure

Study Arms (2)

1

ACTIVE COMPARATOR

Single-dose Sirolimus-Eluting Coronary stent

Device: CYPHER Sirolimus-Eluting Coronary Stent

2

ACTIVE COMPARATOR

Double-dose Sirolimus-Eluting Coronary stent

Device: CYPHER Sirolimus-Eluting Coronary Stent

Interventions

CYPHER Sirolimus-Eluting Coronary Stent DEVICE

Single dose Sirolimus-Eluting coronary stent

Also known as: Cypher Bx Velocity

1

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 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);

You may not qualify if:

• 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);

Sponsors & Collaborators

• Cordis US Corp.: lead

Study Sites (1)

Institute Dante Pazzanese of Cardiology

São Paulo, Brazil

Location

Related Publications (2)

• Costa RA, Sousa JE, Abizaid A, Chaves A, Feres F, Sousa AG, Musumeci G, Mehran R, Fitzgerald PJ, Lansky AJ, Leon MB, Shiran A, Halon DA, Lewis BS, Guagliumi G. The randomised study of the double dose versus single dose sirolimus-eluting stent for the treatment of diabetic patients with de novo coronary lesions. EuroIntervention. 2006 Nov;2(3):295-301.

  PMID: 19755304 RESULT

• 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.

  PMID: 18688066 RESULT

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

• Jose E. Sousa, MD

  Institute Dante Pazzanese of Cardiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 4, 2005
• First Posted: October 6, 2005
• Study Start: May 1, 2003
• Primary Completion: July 1, 2004
• Study Completion: November 1, 2009
• Last Updated: November 19, 2009

Record last verified: 2009-11

Locations

BR (1)