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

This study has been completed.

Sponsored by: Cordis Corporation
Information provided by: Cordis Corporation
ClinicalTrials.gov Identifier: NCT00233792
  Purpose

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 I
Phase II

MedlinePlus related topics:   Coronary Artery Disease   

ChemIDplus related topics:   Sirolimus   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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.

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
1
sirolimus coated Bx VELOCITY stent - fast release
Device: sirolimus coated Bx VELOCITY stent - fast release
2
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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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;
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00233792

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

Sponsors and Collaborators
Cordis Corporation

Investigators
Principal Investigator:     Eduardo J Sousa, MD     Instituto Dante Pazzanese of Cardiology    
  More Information


Publications of Results:

Study ID Numbers:   P99-6301
First Received:   October 4, 2005
Last Updated:   October 11, 2007
ClinicalTrials.gov Identifier:   NCT00233792
Health Authority:   Brazil: National Committee of Ethics in Research

Study placed in the following topic categories:
Sirolimus
Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Clotrimazole
Miconazole
Myocardial Ischemia
Tioconazole
Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:
Anti-Bacterial Agents
Anti-Infective Agents
Immunologic Factors
Antineoplastic Agents
Antifungal Agents
Therapeutic Uses
Physiological Effects of Drugs
Cardiovascular Diseases
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 03, 2008




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