Embolism, Myocardial Ischemia, Saphenous Vein Graft Disease
Conditions
Keywords
Heart disease, Embolic Protection Device, PCI, SVG
Brief summary
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.
Interventions
DEVICEGARDEX™
GARDEX is an embolic protection system to contain and remove embolic material (thrombus/debris) during cardiovascular interventions. The diameter of the vessel at the site of filter basket placement should be between 3.5 mm to 6.0 mm. The GARDEX Embolic Protection System may be used with commercially available 0.014 guide wires.
Sponsors
Gardia Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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: * Diagnosis at time of enrollment of stable or unstable angina pectoris * Reversible 12 lead ECG changes consisted with ischemia * Positive function study (e.g. stress test) * Recent myocardial infarction (\>24 hours prior to enrollment with total CK verified to be within hospital normal limits at the time of enrollment). * 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
* A hypersensitivity or contraindication to heparin and bivalirum (Angiomax), aspirin, ticlopidine, clopidogrel, murine products, procedure equipment material, and a sensitivity to contrast dye which cannot be adequately pre-treated with diphenhydramine and/or steroids. * Myocardial infarction with documented total CK\> 2 times the upper limit of normal within the past 24 hours, or currently experiencing an acute myocardial infarction. * A stroke or transient ischemic attach (TIA) within the past 2 months. * A history of bleeding diathesis or coagulopathy. * Major gastrointestinal (GI) bleeding within 3 months of index procedure. * Baseline creatinine ≥ 2.5 mg/dl. * A planned invasive surgical procedure within 30 days. * Undergone cardiac surgery within the past 60 days. * The lesion is in a SVG that is less than 2 months post implant. * Left ventricular ejection fraction \< 20% * The lesion is an arterial conduit. * Anatomical exclusions that preclude placement of the GARDEX™ system per the Instruction for Use. * More than one SVG graft that need to be treated at the index procedure. * Chronic occlusion of the target lesion/severe calcification.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the study is to evaluate the safety and performance of the GARDEX Protection System. The primary end point is the combined rate of major adverse events (MACE) at 30 days. | 30 days |
Secondary
| Measure | Time frame |
|---|---|
| The secondary study objectives includes Device,Angiographic,Procedural and Clinical Success ,Final TIMI flow grade, Angiographically evident emboli | Device,Angiographic, Procedural Success ,Final TIMI flow grade, Angiographically evident emboli-Procedural; Clinical Success-30 days |
Countries
Israel
Outcome results
None listed