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FIM-BR - First-in-Man Study (Brazil Part) With Sirolimus-Coated BX VELOCITY Stent

NCT ID: NCT00233792

Last Updated: 2007-10-12

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-12-31

Study Completion Date

2005-03-31

Brief Summary

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This is a single center, non-randomized study. Patients will be treated with the sirolimus coated Bx VELOCITY Balloon-Expandable Stent mounted on the Raptor OTW SDS. Patients will have a repeat angiography at four months and will be followed for twelve months post-procedure.

Detailed Description

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This is a single center, non-randomized study of the Bx VELOCITY Balloon-Expandable Stent coated with sirolimus (140µg/cm2) and formulated for fast or slow release. The sirolimus coated stent is mounted on the Raptor OTW SDS. Approximately 30 patients with de novo or restenotic native coronary artery lesions \<=18mm in length and \>=3.0 to \>=3.5 mm in diameter by visual estimate who meet all eligibility criteria will be treated with the sirolimus coated Bx VELOCITY stent(s). Patients will be followed for five years post-procedure and will have a repeat angiography at 4 months, 12 months, 24 months, and 48 months.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

sirolimus coated Bx VELOCITY stent - fast release

Group Type OTHER

sirolimus coated Bx VELOCITY stent - fast release

Intervention Type DEVICE

2

sirolimus coated Bx VELOCITY stent - slow release

Group Type OTHER

sirolimus coated Bx VELOCITY stent - slow release

Intervention Type DEVICE

Interventions

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sirolimus coated Bx VELOCITY stent - fast release

Intervention Type DEVICE

sirolimus coated Bx VELOCITY stent - slow release

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS) or a positive ischemia study;
2. Single de novo or restenotic lesion requiring treatment in a major native coronary artery;
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. Unprotected left main coronary disease with \>=50% stenosis;
3. Have an ostial target lesion;
4. Angiographic evidence of thrombus within target lesion;
5. Calcified lesions which cannot be successfully predilated;
6. Ejection fraction \<=30%;
7. Target lesion involves bifurcation (either stenosis of both main vessel and major branch or stenosis of just major branch);
8. Totally occluded vessel;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cordis Corporation

INDUSTRY

Sponsor Role lead

Principal Investigators

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Eduardo J Sousa, MD

Role: PRINCIPAL_INVESTIGATOR

Instituto Dante Pazzanese of Cardiology

Locations

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Instituto Dante Pazzanese of Cardiology

São Paulo, , Brazil

Site Status

Countries

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Brazil

References

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Sousa JE, Costa MA, Sousa AG, Abizaid AC, Seixas AC, Abizaid AS, Feres F, Mattos LA, Falotico R, Jaeger J, Popma JJ, Serruys PW. Two-year angiographic and intravascular ultrasound follow-up after implantation of sirolimus-eluting stents in human coronary arteries. Circulation. 2003 Jan 28;107(3):381-3. doi: 10.1161/01.cir.0000051720.59095.6d.

Reference Type RESULT
PMID: 12551858 (View on PubMed)

Sousa JE, Costa MA, Abizaid A, Feres F, Seixas AC, Tanajura LF, Mattos LA, Falotico R, Jaeger J, Popma JJ, Serruys PW, Sousa AG. Four-year angiographic and intravascular ultrasound follow-up of patients treated with sirolimus-eluting stents. Circulation. 2005 May 10;111(18):2326-9. doi: 10.1161/01.CIR.0000164271.01172.1A. Epub 2005 Apr 25.

Reference Type RESULT
PMID: 15851603 (View on PubMed)

Aoki J, Abizaid AC, Serruys PW, Ong AT, Boersma E, Sousa JE, Bruining N. Evaluation of four-year coronary artery response after sirolimus-eluting stent implantation using serial quantitative intravascular ultrasound and computer-assisted grayscale value analysis for plaque composition in event-free patients. J Am Coll Cardiol. 2005 Nov 1;46(9):1670-6. doi: 10.1016/j.jacc.2005.06.076. Epub 2005 Oct 10.

Reference Type RESULT
PMID: 16256867 (View on PubMed)

Sousa JE, Costa MA, Abizaid A, Abizaid AS, Feres F, Pinto IM, Seixas AC, Staico R, Mattos LA, Sousa AG, Falotico R, Jaeger J, Popma JJ, Serruys PW. Lack of neointimal proliferation after implantation of sirolimus-coated stents in human coronary arteries: a quantitative coronary angiography and three-dimensional intravascular ultrasound study. Circulation. 2001 Jan 16;103(2):192-5. doi: 10.1161/01.cir.103.2.192.

Reference Type RESULT
PMID: 11208675 (View on PubMed)

Other Identifiers

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P99-6301

Identifier Type: -

Identifier Source: org_study_id