Back to resultsFIM-NL - First-in-Man Study (Netherlands Part) With Sirolimus Coated Modified BX Velocity Stent
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
Sirolimus-coated Bx VELOCITY Stent
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria: Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS) or a positive ischemia study; Single de novo lesion requiring treatment in a major native coronary artery; Target lesion is <=18mm in length (visual estimate); Target lesion is >=3.0mm and <=3.5mm in diameter (visual estimate); Target lesion stenosis is >50% and <100% (visual estimate); Exclusion Criteria: 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; Unprotected left main coronary disease with >=50% stenosis; Have an ostial target lesion; Angiographic evidence of thrombus within target lesion; Calcified lesions which cannot be successfully predilated; Ejection fraction <=30%; Target lesion involves bifurcation (either stenosis of both main vessel and major branch or stenosis of just major branch); Totally occluded vessel;
Sites / Locations
- Erasmus Centrum Thoraxcentrum
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Assessment of in-stent percent diameter stenosis (%DS) measured by quantitative coronary angiography.
Secondary Outcome Measures
Assessment of lesion morphology by intravascular ultrasound (IVUS).
Target vessel failure (TVF).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00233818
Brief Title
FIM-NL - First-in-Man Study (Netherlands Part) With Sirolimus Coated Modified BX Velocity Stent
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 Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
February 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Cordis Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Sirolimus-coated Bx VELOCITY Stent
Primary Outcome Measure Information:
Title
Assessment of in-stent percent diameter stenosis (%DS) measured by quantitative coronary angiography.
Time Frame
post procedure and 6 months
Secondary Outcome Measure Information:
Title
Assessment of lesion morphology by intravascular ultrasound (IVUS).
Time Frame
post procedure and 6 months
Title
Target vessel failure (TVF).
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS) or a positive ischemia study;
Single de novo lesion requiring treatment in a major native coronary artery;
Target lesion is <=18mm in length (visual estimate);
Target lesion is >=3.0mm and <=3.5mm in diameter (visual estimate);
Target lesion stenosis is >50% and <100% (visual estimate);
Exclusion Criteria:
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;
Unprotected left main coronary disease with >=50% stenosis;
Have an ostial target lesion;
Angiographic evidence of thrombus within target lesion;
Calcified lesions which cannot be successfully predilated;
Ejection fraction <=30%;
Target lesion involves bifurcation (either stenosis of both main vessel and major branch or stenosis of just major branch);
Totally occluded vessel;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick W Serruys, MD
Organizational Affiliation
Erasmus Centrum Thoraxcentrum
Official's Role
Principal Investigator
Facility Information:
Facility Name
Erasmus Centrum Thoraxcentrum
City
Rotterdam
ZIP/Postal Code
NL- 3015 GD
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
11686669
Citation
Rensing BJ, Vos J, Smits PC, Foley DP, van den Brand MJ, van der Giessen WJ, de Feijter PJ, Serruys PW. Coronary restenosis elimination with a sirolimus eluting stent: first European human experience with 6-month angiographic and intravascular ultrasonic follow-up. Eur Heart J. 2001 Nov;22(22):2125-30. doi: 10.1053/euhj.2001.2892.
Results Reference
result
PubMed Identifier
12270850
Citation
Degertekin M, Serruys PW, Foley DP, Tanabe K, Regar E, Vos J, Smits PC, van der Giessen WJ, van den Brand M, de Feyter P, Popma JJ. Persistent inhibition of neointimal hyperplasia after sirolimus-eluting stent implantation: long-term (up to 2 years) clinical, angiographic, and intravascular ultrasound follow-up. Circulation. 2002 Sep 24;106(13):1610-3. doi: 10.1161/01.cir.0000034447.02535.d5.
Results Reference
result
Learn more about this trial
FIM-NL - First-in-Man Study (Netherlands Part) With Sirolimus Coated Modified BX Velocity Stent
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