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

This study has been completed.
Information provided by:
Cordis Corporation Identifier:
First received: October 4, 2005
Last updated: October 11, 2007
Last verified: October 2007
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.

Condition Intervention Phase
Coronary Artery Disease
Device: sirolimus coated Bx VELOCITY stent - fast release
Device: sirolimus coated Bx VELOCITY stent - slow release
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

Further study details as provided by Cordis Corporation:

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

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

Enrollment: 30
Study Start Date: December 1999
Study Completion Date: March 2005
Arms Assigned Interventions
sirolimus coated Bx VELOCITY stent - fast release
Device: sirolimus coated Bx VELOCITY stent - fast release
sirolimus coated Bx VELOCITY stent - slow release
Device: sirolimus coated Bx VELOCITY stent - slow release

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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;
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Please refer to this study by its identifier: NCT00233792

Instituto Dante Pazzanese of Cardiology
Sao Paulo, Brazil, 04012-909
Sponsors and Collaborators
Cordis Corporation
Principal Investigator: Eduardo J Sousa, MD Instituto Dante Pazzanese of Cardiology
  More Information

Publications: Identifier: NCT00233792     History of Changes
Other Study ID Numbers: P99-6301
Study First Received: October 4, 2005
Last Updated: October 11, 2007

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on May 22, 2017