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

October 11, 2007 updated by: Cordis Corporation

An Evaluation of the Sirolimus Coated Modified BX VELOCITY Balloon-Expandable Stent in the Treatment of Patients With de Novo or Restenotic Native Coronary Artery Lesions.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 04012-909
        • Instituto Dante Pazzanese of Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1
sirolimus coated Bx VELOCITY stent - fast release
Device: sirolimus coated Bx VELOCITY stent - fast release
Other: 2
sirolimus coated Bx VELOCITY stent - slow release
Device: sirolimus coated Bx VELOCITY stent - slow release

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of in-stent percent diameter stenosis (%DS) measured by quantitative coronary angiography.
Time Frame: post procedure and 6 months
post procedure and 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessment of lesion morphology by intravascular ultrasound (IVUS).
Time Frame: post procedure and 6 months
post procedure and 6 months
Target vessel failure (TVF).
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cordis Corporation

Investigators

  • Principal Investigator: Eduardo J Sousa, MD, Instituto Dante Pazzanese of Cardiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 1999

Study Completion (Actual)

March 1, 2005

Study Registration Dates

First Submitted

October 4, 2005

First Submitted That Met QC Criteria

October 5, 2005

First Posted (Estimate)

October 6, 2005

Study Record Updates

Last Update Posted (Estimate)

October 12, 2007

Last Update Submitted That Met QC Criteria

October 11, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P99-6301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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