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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Gardia Medical
ClinicalTrials.gov Identifier:
NCT01042444
First received: December 30, 2009
Last updated: November 14, 2012
Last verified: November 2012
History of Changes
  Purpose

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 Intervention Phase
Saphenous Vein Graft Disease
Myocardial Ischemia
Embolism
 Device: GARDEX™
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Gardia Medical:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 6
Study Start Date: December 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01042444

Locations
Israel
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
Investigators
Principal Investigator: Uri Rosenschein, MD Bnei Zion Hospital, Haifa Israel
  More Information

No publications provided

Responsible Party: Gardia Medical
ClinicalTrials.gov Identifier: NCT01042444     History of Changes
Other Study ID Numbers: Gardia Medical Ltd.
Study First Received: December 30, 2009
Last Updated: November 14, 2012
Health Authority: Israel: Ethics Commission
Israel: Ministry of Health

Keywords provided by Gardia Medical:
Heart disease
Embolic Protection Device
PCI
SVG

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

ClinicalTrials.gov processed this record on June 17, 2013