Back to resultsFIM-BR - First-in-Man Study (Brazil Part) With Sirolimus-Coated BX VELOCITY Stent
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
sirolimus coated Bx VELOCITY stent - fast release
sirolimus coated Bx VELOCITY stent - slow release
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 or restenotic 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
- Instituto Dante Pazzanese of Cardiology
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
1
2
Arm Description
sirolimus coated Bx VELOCITY stent - fast release
sirolimus coated Bx VELOCITY stent - slow release
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
NCT00233792
Brief Title
FIM-BR - First-in-Man Study (Brazil Part) With Sirolimus-Coated BX VELOCITY Stent
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.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
December 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Cordis Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
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
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
sirolimus coated Bx VELOCITY stent - fast release
Arm Title
2
Arm Type
Other
Arm Description
sirolimus coated Bx VELOCITY stent - slow release
Intervention Type
Device
Intervention Name(s)
sirolimus coated Bx VELOCITY stent - fast release
Intervention Type
Device
Intervention Name(s)
sirolimus coated Bx VELOCITY stent - slow release
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 or restenotic 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
Eduardo J Sousa, MD
Organizational Affiliation
Instituto Dante Pazzanese of Cardiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Dante Pazzanese of Cardiology
City
Sao Paulo
ZIP/Postal Code
04012-909
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
12551858
Citation
Sousa JE, Costa MA, Sousa AG, Abizaid AC, Seixas AC, Abizaid AS, Feres F, Mattos LA, Falotico R, Jaeger J, Popma JJ, Serruys PW. Two-year angiographic and intravascular ultrasound follow-up after implantation of sirolimus-eluting stents in human coronary arteries. Circulation. 2003 Jan 28;107(3):381-3. doi: 10.1161/01.cir.0000051720.59095.6d.
Results Reference
result
PubMed Identifier
15851603
Citation
Sousa JE, Costa MA, Abizaid A, Feres F, Seixas AC, Tanajura LF, Mattos LA, Falotico R, Jaeger J, Popma JJ, Serruys PW, Sousa AG. Four-year angiographic and intravascular ultrasound follow-up of patients treated with sirolimus-eluting stents. Circulation. 2005 May 10;111(18):2326-9. doi: 10.1161/01.CIR.0000164271.01172.1A. Epub 2005 Apr 25.
Results Reference
result
PubMed Identifier
16256867
Citation
Aoki J, Abizaid AC, Serruys PW, Ong AT, Boersma E, Sousa JE, Bruining N. Evaluation of four-year coronary artery response after sirolimus-eluting stent implantation using serial quantitative intravascular ultrasound and computer-assisted grayscale value analysis for plaque composition in event-free patients. J Am Coll Cardiol. 2005 Nov 1;46(9):1670-6. doi: 10.1016/j.jacc.2005.06.076. Epub 2005 Oct 10.
Results Reference
result
PubMed Identifier
11208675
Citation
Sousa JE, Costa MA, Abizaid A, Abizaid AS, Feres F, Pinto IM, Seixas AC, Staico R, Mattos LA, Sousa AG, Falotico R, Jaeger J, Popma JJ, Serruys PW. Lack of neointimal proliferation after implantation of sirolimus-coated stents in human coronary arteries: a quantitative coronary angiography and three-dimensional intravascular ultrasound study. Circulation. 2001 Jan 16;103(2):192-5. doi: 10.1161/01.cir.103.2.192.
Results Reference
result
Learn more about this trial
FIM-BR - First-in-Man Study (Brazil Part) With Sirolimus-Coated BX VELOCITY Stent
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