The RETRIEVE Study: Use of the FiberNet® Embolic Protection System in Saphenous Vein Grafts

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2009-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Post Market Registry Study of the Philips QuickClear Mechanical Thrombectomy System

NCT05928221

Acute Deep Venous Thrombosis of Ileofemoral Vein

ACTIVE_NOT_RECRUITING

Native Coronary Artery Instead of SAphenous Vein Graft Intervention for Treatment of Significant Saphenous Vein Graft Lesions

NCT05187351

Target Vessel Failure in Saphenous Vein Grafts Percutaneous Coronary Intervention

ACTIVE_NOT_RECRUITING

EU Post Market Clinical Follow-Up Study of the Venclose System for Saphenous Vein Incompetence

NCT04236245

Chronic Venous Insufficiency

COMPLETED NA

Post Approval Study - Evaluate the Long-Term Safety and Effectiveness of the WEB Device

NCT04839705

Wide Neck Bifurcation Intracranial Aneurysms

RECRUITING NA

VeClose Five Year Follow-Up Extension Study

NCT03455699

Great Saphenous Vein (GSV) With Venous Reflux Disease

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Saphenous Vein Graft Disease Myocardial Ischemia Embolism

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

FiberNet EPS used during SVG intervention.

The FiberNet EPS is indicated for use as a guide wire and embolic protection system to capture and remove embolic material produced while performing percutaneous transluminal interventional procedures in saphenous vein grafts.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

stenting

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Candidate for percutaneous transluminal coronary angioplasty (PTCA), stenting and emergent coronary artery bypass graft (CABG).
* Myocardial ischemia as evidenced by one or more of the following:

* Diagnosis of stable or unstable angina pectoris
* ECG changes consistent with ischemia
* Positive functional study
* Recent myocardial infarction
* Lesion(s) is located within SVG and is ≥ 50% and \< 100% stenosed.

Exclusion Criteria

Clinical Criteria:

* Myocardial infarction with documented total CK-MB \> 2 times the upper limit of normal within the past 24 hours, or currently experiencing an acute myocardial infarction.
* Undergone cardiac surgery within the past 60 days.
* A planned invasive surgical procedure within 30 days.
* The lesion(s) is in an SVG that is less than 2 months post-implant.
* Left ventricular ejection fraction \< 20%.
* A stroke or transient ischemic neurological attack (TIA) within the past 2 months.

Angiographic Criteria:

* The lesion(s) is in an arterial conduit.
* Lesion is within 10 mm of the proximal anastomosis.
* More than two native lesions \[in addition to the SVG lesion(s)\] that need to be treated at the index procedure.
* More than two SVGs that need to be treated at the index procedure.
* Chronic total occlusion of a target lesion.
* The SVG lesion(s) requires treatment with a large device other than PTCA prior to stent placement (such as, but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, rheolytic thrombectomy or brachytherapy).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No