Phase I Study to Demonstrate the Safety and Performance of the GARDEX™ Embolic Protection Device When Used During Percutaneous Coronary Intervention (PCI) of Saphenous Vein Graft

Gardia Medical3 sites in 1 country6 target enrollmentDecember 2009

ConditionsSaphenous Vein Graft Disease Myocardial Ischemia Embolism

Overview

Phase: N/A
Intervention: Not specified
Conditions: Saphenous Vein Graft Disease
Sponsor: Gardia Medical
Enrollment: 6
Locations: 3
Primary Endpoint: 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.
Status: Terminated
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2009

End Date

January 2011

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Gardia Medical

Responsible Party

Sponsor

Eligibility Criteria

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).

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%

Outcomes

Primary Outcomes

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.

Time Frame: 30 days

Secondary Outcomes

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)