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

NCT ID: NCT00233714

Last Updated: 2009-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2009-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Single-dose Sirolimus-Eluting Coronary stent

Group Type ACTIVE_COMPARATOR

CYPHER Sirolimus-Eluting Coronary Stent

Intervention Type DEVICE

Single dose Sirolimus-Eluting coronary stent

2

Double-dose Sirolimus-Eluting Coronary stent

Group Type ACTIVE_COMPARATOR

CYPHER Sirolimus-Eluting Coronary Stent

Intervention Type DEVICE

Double-dose Sirolimus-Eluting coronary stent

Interventions

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CYPHER Sirolimus-Eluting Coronary Stent

Single dose Sirolimus-Eluting coronary stent

Intervention Type DEVICE

CYPHER Sirolimus-Eluting Coronary Stent

Double-dose Sirolimus-Eluting coronary stent

Intervention Type DEVICE

Other Intervention Names

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Cypher Bx Velocity Cypher Bx Velocity

Eligibility Criteria

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Inclusion Criteria

1. The patient must be minimum 18 years of age;
2. Patients must be previously diagnosed with diabetes with documented treatment with insulin, oral medications, or diet for a minimum of 3 months;
3. 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;
4. 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;
5. The target vessel is 2.5 mm and 3.5mm in diameter (visual estimate);
6. The target lesion is \<30 mm in length (visual estimate) located in a native coronary artery;
7. Target lesion stenosis is \>50% and \<100% (TIMI I) (visual estimate);

Exclusion Criteria

1. 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;
2. Patients admitted for treatment of diabetic ketoacidosis \> 2 times in the past six months (Brittle Diabetics);
3. Ejection fraction 30%;
4. Impaired renal function (creatinine \> 2.0 mg/dL);
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cordis Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Cordis

Principal Investigators

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Jose E. Sousa, MD

Role: PRINCIPAL_INVESTIGATOR

Institute Dante Pazzanese of Cardiology

Locations

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Institute Dante Pazzanese of Cardiology

São Paulo, , Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type RESULT
PMID: 19755304 (View on PubMed)

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.

Reference Type RESULT
PMID: 18688066 (View on PubMed)

Other Identifiers

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P03-6318

Identifier Type: -

Identifier Source: org_study_id