The RETRIEVE Study: Use of the FiberNet® Embolic Protection System in Saphenous Vein Grafts
Completed · Not applicable
Conditions studied: Saphenous Vein Graft Disease, Myocardial Ischemia, Embolism
In brief
This is a multicenter, prospective study designed to demonstrate the performance and safety of the FiberNet Embolic Protection System when used as an adjunctive device during saphenous vein graft (SVG) intervention.
Key facts
- Study ID
- NCT00453518
- Run by
- Lumen Biomedical
- People needed
- 29
- Starts
- 2007-03-01
- Expected to finish
- 2009-02-01
- Last updated by the study team
- 2009-08-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Candidate for percutaneous transluminal coronary angioplasty (PTCA), stenting and emergent coronary artery bypass graft (CABG).
- Myocardial ischemia as evidenced by one or more of the following:
- Diagnosis of stable or unstable angina pectoris
- ECG changes consistent with ischemia
- Positive functional study
- Recent myocardial infarction
- Lesion(s) is located within SVG and is ≥ 50% and < 100% stenosed.
You may not qualify if…
- Clinical Criteria:
- Myocardial infarction with documented total CK-MB > 2 times the upper limit of normal within the past 24 hours, or currently experiencing an acute myocardial infarction.
- Undergone cardiac surgery within the past 60 days.
- A planned invasive surgical procedure within 30 days.
- The lesion(s) is in an SVG that is less than 2 months post-implant.
- Left ventricular ejection fraction < 20%.
- A stroke or transient ischemic neurological attack (TIA) within the past 2 months.
- Angiographic Criteria:
- The lesion(s) is in an arterial conduit.
- Lesion is within 10 mm of the proximal anastomosis.
- More than two native lesions [in addition to the SVG lesion(s)] that need to be treated at the index procedure.
- More than two SVGs that need to be treated at the index procedure.
- Chronic total occlusion of a target lesion.
- The SVG lesion(s) requires treatment with a large device other than PTCA prior to stent placement (such as, but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, rheolytic thrombectomy or brachytherapy).
Where it is running
- Munroe Regional Medical Center — Ocala, Florida, United States
- St. Vincent Hospital — Indianapolis, Indiana, United States
- William Beaumont Hospital — Royal Oak, Michigan, United States
- Christ Hospital — Cincinnati, Ohio, United States
- Riverside Methodist Hospital — Columbus, Ohio, United States
- Lehigh Valley Hospital — Allentown, Pennsylvania, United States
Full record on ClinicalTrials.gov
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