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.|
|ClinicalTrials.gov Identifier: NCT01042444|
Recruitment Status : Terminated
First Posted : January 5, 2010
Last Update Posted : January 3, 2018
|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)|
|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|
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.
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.
- 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 ]
- 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 ]
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 ClinicalTrials.gov 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|
|Principal Investigator:||Uri Rosenschein, MD||Bnei Zion Hospital, Haifa Israel|