Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

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

Lead Sponsor:

Lumen Biomedical

Conditions:

Saphenous Vein Graft Disease

Myocardial Ischemia

Eligibility:

All Genders

18+ years

Phase:

NA

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...

Detailed 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 wil...

Eligibility Criteria

Inclusion

  • 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

  • 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).

Key Trial Info

Start Date :

March 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 1 2009

Estimated Enrollment :

29 Patients enrolled

Trial Details

Trial ID

NCT00453518

Start Date

March 1 2007

End Date

February 1 2009

Last Update

August 18 2009

Active Locations (6)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 2 (6 locations)

1

Munroe Regional Medical Center

Ocala, Florida, United States, 34474

2

St. Vincent Hospital

Indianapolis, Indiana, United States, 46290

3

William Beaumont Hospital

Royal Oak, Michigan, United States, 48073

4

Christ Hospital

Cincinnati, Ohio, United States, 45219