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

This study has been completed.
Sponsor:
Information provided by:
Cordis Corporation
ClinicalTrials.gov Identifier:
NCT00233792
First received: October 4, 2005
Last updated: October 11, 2007
Last verified: October 2007
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sirolimus
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014