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

Primary Purpose

Saphenous Vein Graft Disease, Myocardial Ischemia, Embolism

Status

Terminated

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

GARDEX™

About this trial

This is an interventional treatment trial for Saphenous Vein Graft Disease focused on measuring Heart disease, Embolic Protection Device, PCI, SVG

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Bnai Zion Medical Center
Rabin Medical Center - Beilinson Campus
Tel-Aviv Sourasky Medical Center, Ichilov Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Embolic Protection Device

Arm Description

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.

Outcomes

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.

Secondary Outcome Measures

The secondary study objectives includes Device,Angiographic,Procedural and Clinical Success ,Final TIMI flow grade, Angiographically evident emboli

Full Information

NCT ID

NCT01042444

First Posted

December 30, 2009

Last Updated

January 1, 2018

Sponsor

Gardia Medical

1. Study Identification

Unique Protocol Identification Number

NCT01042444

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Terminated

Study Start Date

December 2009 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Gardia Medical

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Saphenous Vein Graft Disease, Myocardial Ischemia, Embolism

Keywords

Heart disease, Embolic Protection Device, PCI, SVG

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Embolic Protection Device

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

GARDEX™

Intervention Description

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 Measure Information:

Title

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 Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

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). 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Uri Rosenschein, MD

Organizational Affiliation

Bnei Zion Hospital, Haifa Israel

Official's Role

Principal Investigator

Facility Information:

Facility Name

Bnai Zion Medical Center

City

Haifa

ZIP/Postal Code

33394

Country

Israel

Facility Name

Rabin Medical Center - Beilinson Campus

City

Petach Tikva

ZIP/Postal Code

49100

Country

Israel

Facility Name

Tel-Aviv Sourasky Medical Center, Ichilov Hospital

City

Tel Aviv

ZIP/Postal Code

64239

Country

Israel

12. IPD Sharing Statement

Learn more about this trial

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

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