Use of the GARDEX™ Embolic Protection Device During Percutaneous Coronary Interventions of Saphenous Vein Graft
This study has been terminated.
Information provided by (Responsible Party):
First received: December 30, 2009
Last updated: November 14, 2012
Last verified: November 2012
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.
Saphenous Vein Graft Disease
||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
||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
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 ]
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 ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||January 2011 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||18 Years to 90 Years (Adult, Senior)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
||Uri Rosenschein, MD
||Bnei Zion Hospital, Haifa Israel
History of Changes
|Other Study ID Numbers:
Gardia Medical Ltd.
|Study First Received:
||December 30, 2009
||November 14, 2012
Keywords provided by Gardia Medical:
Embolic Protection Device
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 18, 2017
Coronary Artery Disease
Embolism and Thrombosis
Arterial Occlusive Diseases