Clinical Trials Logo

Clinical Trial Summary

This is a multicenter, prospective study designed to demonstrate the performance and safety of the FiberNet Embolic Protection System when used as an adjunctive device during saphenous vein graft (SVG) intervention.


Clinical Trial Description

The study will involve up to 30 patients to be enrolled using the FiberNet device during clinically indicated percutaneous intervention of SVG and followed through 30 days post procedure. Patients will be enrolled at up to 10 Investigative Sites. The study is a prospective multi-center registry with sequential enrollment of qualified patients who consent to participate and meet all entrance criteria.

The Lumen Biomedical, Inc. FiberNet® Embolic Protection System is indicated for use as a guide wire and embolic protection system to capture and remove embolic material (thrombus/debris) produced while performing percutaneous transluminal interventional procedures in saphenous vein grafts with reference vessel diameters of 1.75 mm to 7.0 mm. ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00453518
Study type Interventional
Source Lumen Biomedical
Contact
Status Completed
Phase N/A
Start date March 2007
Completion date February 2009

See also
  Status Clinical Trial Phase
Not yet recruiting NCT06032572 - Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE) N/A
Recruiting NCT05846893 - Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease N/A
Completed NCT04153006 - Comparison of Fingerstick Versus Venous Sample for Troponin I.
Completed NCT01205776 - EXCEL Clinical Trial N/A
Active, not recruiting NCT04555174 - BIOFLOW-VIII All-comers Orsiro Mission Safety and Performance Registry
Recruiting NCT04582877 - Pressure Guidewire System Multi-center, Prospective, Self-Control, Clinical Trial N/A
Recruiting NCT04390672 - Multivessel TALENT N/A
Recruiting NCT03265535 - Validation of a Single Rest-Stress Imaging Protocol for Myocardial Perfusion Imaging
Not yet recruiting NCT04522583 - Increased CRP Concentrations in Patients Admitted to the Emergency Department With Troponin Elevation Aids to Rule Out Coronary Ischemia
Completed NCT02510547 - Comparison of a CrossBoss First Versus Standard Wire Escalation Strategy for Crossing Coronary Chronic Total Occlusion: the "CrossBoss First" Trial Phase 4
Completed NCT02554006 - Predischarge Bundle to Minimize Negative Impact on Quality of Life of Nuisance Bleedings N/A
Terminated NCT02407626 - Optimization of Cardioprotection in Diabetic Patients Undergoing Cardiac Surgery N/A
Active, not recruiting NCT02189499 - Feasibility Study of the Amaranth Medical FORTITUDE Bioresorbable Drug-Eluting Coronary Stent Phase 2
Completed NCT02264717 - Dan-NICAD - Danish Study of Non-Invasive Diagnostic Testing in Coronary Artery Disease N/A
Completed NCT02197065 - Pilot Study of Atorvastatin for Orthopedic Surgery Patients Phase 2
Recruiting NCT01681381 - Evaluate Safety And Effectiveness Of The Tivoli® DES and The Firebird2® DES For Treatment Coronary Revascularization N/A
Completed NCT01679886 - Comparison of Rubidium PET and SPECT With CZT Crystals for Detection of Myocardial Ischemia in Overweighed Patients and Women N/A
Terminated NCT01892917 - BIOFLOW-III Hungary Satellite Registry N/A
Completed NCT01655043 - Absolute Quantification of Coronary Flow Reserve by Stress Perfusion MRI Phase 2
Completed NCT02707445 - Genotyping Influences Outcome of Coronary Artery Stenting N/A