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This is a multi center, prospective study designed to demonstrate the safety and performance of the GARDEX Embolic Protection System when used as an adjunctive device during saphenous vein graft (SVG) interventions.
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Inclusion criteria
Anticipated patient life expectancy of at least 1 year from enrollment.
Patient (or their legal guardian) has provided a signed informed consent.
Patient is willing to comply with the protocol requirements.
Candidate for PCI, stenting and CABG.
Total CK verified to be within hospital normal limits at the time of enrollment.
Myocardial ischemia as evidenced by one or more of the following:
Lesions amendable to PCI.
Lesion(s) is located within SVG and has ≥50% and <100% stenosis (angiographic visual assessment).
Only single SVG graft to be treated.
Vessel has thrombolysis in myocardial infarction (TIMI) grade 1 or higher flow before the passage of a guidewire.
Reference vessel diameter where the GARDEX™ system is to be placed is ≥ 3.5mm and ≤6.0mm in diameter by angiographic visual estimation.
Exclusion criteria
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Interventional model
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6 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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