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FIM-NL - First-in-Man Study (Netherlands Part) With Sirolimus Coated Modified BX Velocity Stent

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ClinicalTrials.gov Identifier: NCT00233818
Recruitment Status : Completed
First Posted : October 6, 2005
Last Update Posted : October 12, 2007
Sponsor:
Information provided by:
Cordis Corporation

Brief Summary:
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 or disease Intervention/treatment Phase
Coronary Artery Disease Device: Sirolimus-coated Bx VELOCITY Stent Phase 1 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : February 2000
Actual Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
1 Device: Sirolimus-coated Bx VELOCITY Stent



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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:
ClinicalTrials.gov Identifier: NCT00233818     History of Changes
Other Study ID Numbers: EC99-07
First Posted: October 6, 2005    Key Record Dates
Last Update Posted: October 12, 2007
Last Verified: October 2007

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
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs