Use of the GARDEX™ Embolic Protection Device During Percutaneous Coronary Interventions of Saphenous Vein Graft

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01042444
Recruitment Status : Terminated
First Posted : January 5, 2010
Last Update Posted : January 3, 2018
Information provided by (Responsible Party):
Gardia Medical

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.

Condition or disease Intervention/treatment Phase
Saphenous Vein Graft Disease Myocardial Ischemia Embolism Device: GARDEX™ Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2009
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Arm Intervention/treatment
Experimental: Embolic Protection Device
The study will involve up to 20 patients to be enrolled using the GARDEX system during clinically indicated percutaneous intervention of SVG and followed through 30 days post procedure. Patients will be enrolled at up to 3 investigative sites. The study is a prospective multi center registry with sequential enrollment of qualified patients who consent to participate and meet the eligibility criteria.
Device: GARDEX™

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.

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. The secondary study objectives includes Device,Angiographic,Procedural and Clinical Success ,Final TIMI flow grade, Angiographically evident emboli [ Time Frame: Device,Angiographic, Procedural Success ,Final TIMI flow grade, Angiographically evident emboli-Procedural; Clinical Success-30 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01042444

Bnai Zion Medical Center
Haifa, Israel, 33394
Rabin Medical Center - Beilinson Campus
Petach Tikva, Israel, 49100
Tel-Aviv Sourasky Medical Center, Ichilov Hospital
Tel Aviv, Israel, 64239
Sponsors and Collaborators
Gardia Medical
Principal Investigator: Uri Rosenschein, MD Bnei Zion Hospital, Haifa Israel

Responsible Party: Gardia Medical Identifier: NCT01042444     History of Changes
Other Study ID Numbers: Gardia Medical Ltd.
First Posted: January 5, 2010    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: January 2018

Keywords provided by Gardia Medical:
Heart disease
Embolic Protection Device

Additional relevant MeSH terms:
Myocardial Ischemia
Coronary Artery Disease
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Heart Diseases
Coronary Disease
Arterial Occlusive Diseases