Clinical trial NCT01042444: 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
Overall status: TERMINATED
Phase: NA
Conditions: Saphenous Vein Graft Disease
Myocardial Ischemia
Embolism
Keywords: Heart disease
Embolic Protection Device
PCI
SVG
Lead sponsor: Gardia Medical
Sponsor class: INDUSTRY
First posted: 2010-01-05
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 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.
timeFrame: 30 days
Secondary outcomes:
measure: The secondary study objectives includes Device,Angiographic,Procedural and Clinical Success ,Final TIMI flow grade, Angiographically evident emboli
timeFrame: Device,Angiographic, Procedural Success ,Final TIMI flow grade, Angiographically evident emboli-Procedural; Clinical Success-30 days
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
city: Petach Tikva
country: Israel
facility: Rabin Medical Center - Beilinson Campus
city: Tel Aviv
country: Israel
facility: Tel-Aviv Sourasky Medical Center, Ichilov Hospital
Study officials:
affiliation: Bnei Zion Hospital, Haifa Israel
name: Uri Rosenschein, MD
role: PRINCIPAL_INVESTIGATOR
References: