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

January 1, 2018 updated by: Gardia Medical

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel, 33394
        • Bnai Zion Medical Center
      • Petach Tikva, Israel, 49100
        • Rabin Medical Center - Beilinson Campus
      • Tel Aviv, Israel, 64239
        • Tel-Aviv Sourasky Medical Center, Ichilov Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome 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.
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Device,Angiographic, Procedural Success ,Final TIMI flow grade, Angiographically evident emboli-Procedural; Clinical Success-30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gardia Medical

Investigators

  • Principal Investigator: Uri Rosenschein, MD, Bnei Zion Hospital, Haifa Israel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

December 30, 2009

First Submitted That Met QC Criteria

January 4, 2010

First Posted (Estimate)

January 5, 2010

Study Record Updates

Last Update Posted (Actual)

January 3, 2018

Last Update Submitted That Met QC Criteria

January 1, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Gardia Medical Ltd.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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