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

Not Applicable

Terminated

• Conditions: Embolism; Saphenous Vein Graft Disease; Myocardial Ischemia
• Interventions: Device: GARDEX™

• Registration Number: NCT01042444
• Lead Sponsor: Gardia Medical

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2009-12-30
• Study First Submitted QC: 2010-01-04
• Study First Posted: 2010-01-05
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-01
• Last Update Posted: 2018-01-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Embolic Protection Device	GARDEX™	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Bnai Zion Medical Center; 🇮🇱 Haifa, Israel

Tel-Aviv Sourasky Medical Center, Ichilov Hospital; 🇮🇱 Tel Aviv, Israel

Rabin Medical Center - Beilinson Campus; 🇮🇱 Petach Tikva, Israel