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Evaluation of Two Reduced Sirolimus Doses in Treatment of de Novo Coronary Artery Lesions (REDOX)

NCT ID: NCT00233766

Last Updated: 2008-04-24

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-09-30

Study Completion Date

2007-12-31

Brief Summary

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The objective of this study is to assess the performance and safety of two reduced sirolimus doses on the Bx VELOCITY Balloon-Expandable stent, mounted on the Raptorâ rapid exchange (RX) Stent Delivery System (SDS) in patients with de novo native coronary artery lesions.

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

Interventions

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Bx VELOCITY Stent containing 45% and 70% of Sirolimus dose

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Male or non-pregnant female patient minimum 18 years of age
2. No significant (\>50%) untreated stenoses proximal or distal to the target lesion that will not be treated during the procedure and may require revascularization or impede runoff;
3. Target lesion is 18mm in length (visual estimate);
4. Target lesion is 3.0mm and 3.5mm in diameter (visual estimate);
5. Target lesion stenosis is \>50% and \<100% (visual estimate);

Exclusion Criteria

1. A Q-wave or non-Q-wave myocardial infarction within the preceding 72 hours unless the CK and CK-MB enzymes are back to normal;
2. Ejection fraction 30%;
3. Stent placement of target lesion covers a side branch \>2.0mm in diameter;
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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Instituto Dante Pazzanese de Cardiologia

Principal Investigators

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J. E. Sousa, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto Dante Pazzanese de Cardiologia

Locations

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Instituto Dante Pazzanese de Cardiologia

São Paulo, , Brazil

Site Status

Countries

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Brazil

References

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Nakamura M, Abizaid A, Hirohata A, Honda Y, Sousa JE, Fitzgerald PJ. Efficacy of reduced-dose sirolimus-eluting stents in the human coronary artery: serial IVUS analysis of neointimal hyperplasia and luminal dimension. Catheter Cardiovasc Interv. 2007 Dec 1;70(7):946-51. doi: 10.1002/ccd.21272.

Reference Type BACKGROUND
PMID: 17621671 (View on PubMed)

Other Identifiers

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P02-6314

Identifier Type: -

Identifier Source: org_study_id