Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
FIM-NL - First-in-Man Study (Netherlands Part) With Sirolimus Coated Modified BX Velocity Stent
This study has been completed.
Sponsored by: Cordis Corporation
Information provided by: Cordis Corporation
ClinicalTrials.gov Identifier: NCT00233818
  Purpose

The objective of this study is to assess the performance and safety of a formulation of the antiproliferative agent, sirolimus coated on modified Bx VELOCITY Balloon-Expandable Stent mounted on the Raptor Over The Wire (OTW) Stent Delivery System (SDS) in patients with de novo coronary artery lesions.


Condition Intervention Phase
Coronary Artery Disease
Device: Sirolimus-coated Bx VELOCITY Stent
Phase I
Phase II

MedlinePlus related topics: Coronary Artery Disease
Drug Information available for: 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 Sirolimus-Coated Modified BX VELOCITY Balloon-Expandable Stents for the Treatment of Patients With de Novo 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: 15
Study Start Date: February 2000
Study Completion Date: June 2005
Arms Assigned Interventions
1 Device: Sirolimus-coated Bx VELOCITY Stent

Detailed Description:

This is a single center, non-randomized study. Patients who meet the eligibility criteria will be treated with the sirolimus coated modified Bx VELOCITY Balloon-Expandable Stent mounted on the Raptor OTW SDS. Patients will be followed for five years post-procedure, with all patients having a repeat angiography at 6 months, 18 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 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: NCT00233818

Locations
Netherlands
Erasmus Centrum Thoraxcentrum
Rotterdam, Netherlands, NL- 3015 GD
Sponsors and Collaborators
Cordis Corporation
Investigators
Principal Investigator: Patrick W Serruys, MD Erasmus Centrum Thoraxcentrum
  More Information

Publications of Results:
Study ID Numbers: EC99-07
Study First Received: October 4, 2005
Last Updated: October 11, 2007
ClinicalTrials.gov Identifier: NCT00233818  
Health Authority: Netherlands: Independent Ethics Committee

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 January 16, 2009