NCT00453518

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2007

Typical duration for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

March 28, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 29, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

August 18, 2009

Status Verified

August 1, 2009

Enrollment Period

1.9 years

First QC Date

March 28, 2007

Last Update Submit

August 17, 2009

Conditions

Saphenous Vein Graft DiseaseMyocardial IschemiaEmbolism

Keywords

SVGSaphenous Vein GraftEmbolic ProtectionDistal ProtectionEPDFiberNetSaphenous Vein Graft intervention

Outcome Measures

Primary Outcomes (1)

  • The primary objective of the study is to evaluate the safety and performance of the FiberNet Embolic Protection System. The primary endpoint is major adverse cardiac events (MACE) rate at 30 days.

    30 days

Secondary Outcomes (1)

  • The secondary study objectives are endpoints related to the use of the FiberNet system and additional safety endpoints.

    index hospitalization

Interventions

FiberNet EPS used during SVG intervention.DEVICE

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.

Also known as: stenting

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Munroe Regional Medical Center

Ocala, Florida, 34474, United States

Location

St. Vincent Hospital

Indianapolis, Indiana, 46290, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Riverside Methodist Hospital

Columbus, Ohio, 43214, United States

Location

Lehigh Valley Hospital

Allentown, Pennsylvania, 18105, United States

Location

Related Links

MeSH Terms

Conditions

Myocardial IschemiaEmbolism

Interventions

Stents

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesEmbolism and Thrombosis

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and Supplies

Study Officials

  • Robert Feldman, MD

    Munroe Regional Medical Center

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 28, 2007

First Posted

March 29, 2007

Study Start

March 1, 2007

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

August 18, 2009

Record last verified: 2009-08

Locations

US(6)