Saphenous Vein Graft DiseaseRETRIEVENCT00453518
The RETRIEVE Study: Use of the FiberNet® Embolic Protection System in Saphenous Vein Grafts
A study testing FiberNet EPS used during SVG intervention. in people with Saphenous Vein Graft Disease and Myocardial Ischemia, run by Lumen Biomedical at 6 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Saphenous Vein Graft Disease, Myocardial Ischemia, Embolism
- What is being tested?
- FiberNet EPS used during SVG intervention.
- Type of treatment
- Medical device
- How many people
- 29 participants
- Where
- 6 sitesUnited States
- Study dates
- Mar 2007to Feb 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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%.
Show all 14Show fewer
- 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).
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Lehigh Valley Hospital
Allentown, Pennsylvania, 18105
Christ Hospital
Cincinnati, Ohio, 45219
Riverside Methodist Hospital
Columbus, Ohio, 43214
St. Vincent Hospital
Indianapolis, Indiana, 46290
Munroe Regional Medical Center
Ocala, Florida, 34474
William Beaumont Hospital
Royal Oak, Michigan, 48073
About this study
Official title: Evaluating the Use of the FiberNet® Embolic Protection System in Saphenous Vein Grafts: The RETRIEVE Study
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.
Read the 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 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
- Saphenous Vein Graft Disease, Myocardial Ischemia, Embolism
- Being tested
- FiberNet EPS used during SVG intervention.
- Keywords
- SVG, Saphenous Vein Graft, Embolic Protection, Distal Protection, EPD, FiberNet, Saphenous Vein Graft intervention
- Medical subject headings
- Myocardial Ischemia, Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FiberNet EPS used during SVG intervention.Device
Also called stenting
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (1)
The secondary study objectives are endpoints related to the use of the FiberNet system and additional safety endpoints.
Measured: index hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2007 (estimated)
- Study startMar 2007
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Saphenous Vein Graft DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lumen Biomedical
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Robert Feldman, MD, Munroe Regional Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00453518
- Sponsor's protocol ID
- 90-1004
- Acronym
- RETRIEVE
- Status last verified
- Aug 2009
- First submitted
- 28 Mar 2007
- Last updated
- 18 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Use of the FiberNet® Embolic Protection System in Saphenous Vein Grafts: The RETRIEVE Study
- ClinicalTrials.gov ID
- NCT00453518
- Acronym / sponsor ID
- RETRIEVE / 90-1004
- Conditions
- Saphenous Vein Graft Disease, Myocardial Ischemia, Embolism
- Keywords
- SVG, Saphenous Vein Graft, Embolic Protection, Distal Protection, EPD, FiberNet, Saphenous Vein Graft intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Lumen BiomedicalIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 29 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- Lesion(s) is located within SVG and is ≥ 50% and < 100% stenosed.
Key exclusion criteria (14 listed)
- 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%.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FiberNet EPS used during SVG intervention.Also: stentingThe 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. | Device | – |
Primary outcome
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.
Time frame: 30 days
1 secondary outcome
The secondary study objectives are endpoints related to the use of the FiberNet system and additional safety endpoints.
Time frame: index hospitalization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2009.
- Lumen Biomedical websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Feldman, MD
Munroe Regional Medical Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FiberNet EPS used during SVG intervention. in people with Saphenous Vein Graft Disease and Myocardial Ischemia, run by Lumen Biomedical at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2009.