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

Myocardial Ischemia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01042444
• Other study ID #: Gardia Medical Ltd.
• Status: Terminated
• Phase: N/A
• First received: December 30, 2009
• Last updated: January 1, 2018
• Start date: December 2009
• Est. completion date: January 2011

Study information

• Verified date: January 2018
• Source: Gardia Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Embolism
• Ischemia
• Myocardial Ischemia
• Saphenous Vein Graft Disease

Intervention

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.

Locations

Country	Name	City	State
Israel	Bnai Zion Medical Center	Haifa
Israel	Rabin Medical Center - Beilinson Campus	Petach Tikva
Israel	Tel-Aviv Sourasky Medical Center, Ichilov Hospital	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Gardia Medical

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		30 days
Secondary	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