Symptomatic Ischemic Saphenous Vein Graft Disease
Conditions
Keywords
Covered Stent System, Saphenous Vein Graft, Coronary Artery Bypass[MeSH], Stents[MeSH]
Brief summary
The objective of the Symbiot III Clinical Trial was to evaluate the safety and effectiveness of the Symbiot Covered Stent System in the treatment of symptomatic ischemic saphenous vein bypass graft disease.
Detailed description
Symbiot III was a prospective, multi-center, randomized, controlled trial to evaluate the safety and efficacy of the Symbiot stent compared to bare metal stents in the treatment of symptomatic ischemic saphenous vein graft disease. Randomization was stratified by the intended use of intravenous glycoprotein IIb/IIIa inhibitors and by the intended use of approved distal protection to ensure approximate balance between study treatments within each of the strata. The primary outcome variable for the study was target lesion percent diameter stenosis at 8 months post-implant.
Interventions
DEVICECovered Stent System
Self-expanding, polytetrafluoroethylene(PTFE)-covered, stent system
DEVICEBare metal stent
Any commercially available bare metal stent for coronary indication
Sponsors
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
General Inclusion Criteria: 1. Patient \>=18 years old 2. Patients is eligible for percutaneous coronary intervention and stenting 3. Patient is an acceptable candidate for repeat CABG 4. CPK must be within ULN on the day of the procedure 5. Patient must meet one of the following requirements: * treatment of one or two de novo or restenotic lesions in a single SVG * treatment of both a native coronary artery and the target graft in a single procedure, provided that the native artery is treated prior to randomization of the target lesion(s) and did not result in MACE or TIMI flow \<3 6. Patients (or their legal representative) understands the nature of the procedure and study requirements and provides written informed consent before any study specific tests or procedures are performed 7. Patient is willing to comply with specified follow-up evaluations at the specified times and locations 8. Patient has angina pectoris (CCS 1, 2, 3, or 4) or coronary ischemia documented by a positive functional ischemia study 9. Patient has no child bearing potential or has a negative pregnancy test within 7 days prior to treatment Angiographic Inclusion Criteria: 1. Target lesion(s) are located within a single SVG 2. Reference vessel \>=3.5 mm and \<=5.5mm in diameter at the stent deployment site 3. Cumulative target lesion length is \<=41mm 4. Target lesion(s) randomized to treatment with the study device must be completely covered by 1 or 2 stents (maximum allowable aggregate stent length in target vessel of 51 mm) 5. Target lesion stenosis \>=50% and \<100% General
Exclusion criteria
1. Patient is currently enrolled in another IRB-approved trial that has not reached the primary endpoint visit or is still in the active treatment phase 2. Patient has been previously enrolled in any Symbiot Trial 3. Patient has documented left ventricular ejection fraction of \<30% within 30 days of enrollment 4. Patient has had a myocardial infarction within 48 hours prior to trial procedure and/or CK-MB \>2X the ULN 5. Patient has had, or will have, a planned additional interventional procedure to any coronary vessel (coronary artery or saphenous vein graft) that does not meet the following criteria: If the staged procedure is chosen for non-study percutaneous intervention to any non-target vessel: * 30 days or more prior to the index procedure is allowed * Between 24 hours and 30 days prior to the index procedure is allowed provided that no major adverse cardiac events resulted from the staged non-study procedure * Within 24 hours prior to the index procedure not allowed * Within 30 days after the index procedure is not allowed * 30 days or more after the index procedure is allowed 6. The lesion to be treated is within 10 mm of any anastomosis 7. Patient has life expectancy of less than 1 year due to other medical conditions 8. The lesion(s) to be treated requires debulking prior to stent placement 9. Patient has a pre-existing condition for which aspirin is contraindicated 10. Patient has a pre-existing condition for which clopidogrel and ticlopidine are contraindicated 11. Patient has a known hypersensitivity to nickel Angiographic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent diameter stenosis at 8 months post-implant | 8 Months |
Secondary
| Measure | Time frame |
|---|---|
| Major adverse cardiac event rate at 30 days post-implant | 30 Days |
Countries
Canada, United States
Outcome results
None listed