|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | March 28, 2007 | ||||
| Last Updated Date | August 17, 2009 | ||||
| Start Date ICMJE | March 2007 | ||||
| Primary Completion Date | February 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
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. | ||||
| Change History | Complete list of historical versions of study NCT00453518 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
The secondary study objectives are endpoints related to the use of the FiberNet system and additional safety endpoints. [ Time Frame: index hospitalization ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE |
The secondary study objectives are endpoints related to the use of the FiberNet system and additional safety endpoints. | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The RETRIEVE Study: Use of the FiberNet® Embolic Protection System in Saphenous Vein Grafts | ||||
| Official Title ICMJE | Evaluating the Use of the FiberNet® Embolic Protection System in Saphenous Vein Grafts: The RETRIEVE Study | ||||
| 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. |
||||
| 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 Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety Study | ||||
| Condition ICMJE |
|
||||
| Intervention ICMJE | Device: FiberNet EPS used during SVG intervention. | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 29 | ||||
| Completion Date | February 2009 | ||||
| Primary Completion Date | February 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: Clinical Criteria:
Angiographic Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00453518 | ||||
| Responsible Party | Jill Moland, Sr. CRA, Lumen Biomedical, Inc. | ||||
| Study ID Numbers ICMJE | 90-1004 | ||||
| Study Sponsor ICMJE | Lumen Biomedical | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
|
||||
| Information Provided By | Lumen Biomedical | ||||
| Verification Date | August 2009 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||