Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00459446
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2007-04-11
Brief Title:
Imaging of Totally Blocked Arteries
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Gadofosveset Imaging of Chronic Total Peripheral Artery Occlusion CTO
Status:
COMPLETED
Status Verified Date:
2008-11-25
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will test how well a new contrast agent dye used in magnetic resonance imaging MRI can help visualize totally blocked arteries that normally supply blood to the neck arms or legs Currently used agents work well in visualizing normal or partly blocked arteries arteries that have some blood flowing through them but only poorly in totally blocked arteries This study will see if a contrast agent called gadofosveset can better brighten images of completely blocked arteries Gadofosveset is approved in Europe for use in MRI scans but is still considered experimental in the United States
People 18 years of age or older with known or suspected total blockage of an artery to the neck arm or leg may be eligible for this study
Participants undergo MRI scanning with gadofosveset contrast dye MRI uses a magnetic field and radio waves to produce images of body tissues and organs For this procedure the subject lies on a table that can slide in and out of the tubular scanner wearing earplugs to muffle loud noises that occur during the scanning process The procedure lasts about 15 to 2 hours during which the subject may be asked to hold his or her breath several times for as long as 5 to 20 seconds During the procedure gadofosveset is injected and several kinds of MRI pictures are taken to understand better how the new agent works Subjects may be asked to undergo a second scan using conventional MRI contrast dye
People 18 years of age or older with known or suspected total blockage of an artery to the neck arm or leg may be eligible for this study
Participants undergo MRI scanning with gadofosveset contrast dye MRI uses a magnetic field and radio waves to produce images of body tissues and organs For this procedure the subject lies on a table that can slide in and out of the tubular scanner wearing earplugs to muffle loud noises that occur during the scanning process The procedure lasts about 15 to 2 hours during which the subject may be asked to hold his or her breath several times for as long as 5 to 20 seconds During the procedure gadofosveset is injected and several kinds of MRI pictures are taken to understand better how the new agent works Subjects may be asked to undergo a second scan using conventional MRI contrast dye
Detailed Description:
Repairing totally occluded peripheral arteries remains challenging because they are not visualized using available imaging technologies Contrast-enhanced magnetic resonance angiography CE-MRA X-ray computed tomography angiography CTA and invasive radiocontrast digital subtraction angiography DSA all rely on blood flow within arteries that are not totally occluded Where the arterial lumen is totally occluded contrast does not enter and the artery remains invisible As a result physicians have difficulty identifying a pathway or trajectory for catheter devices in order to improve blood flow using angioplasty
Gadofosveset an albumin-binding MRI contrast agent that is commercially available outside the United States may accumulate in the walls of occluded arteries through a mechanism that is not known
The goal of this protocol is to determine whether gadofosveset has value in planning catheter trajectories in totally occluded peripheral arteries We propose to study the gadofosveset contrast enhancement patterns in occluded peripheral artery segments in up to 20 patients with known occluded iliac femoral and shoulder arteries being considered for catheter-based treatment
This research may have value in planning and conducting minimally invasive treatments using conventional X-ray guidance and possibly in the future using investigational real-time MRI guidance
Gadofosveset an albumin-binding MRI contrast agent that is commercially available outside the United States may accumulate in the walls of occluded arteries through a mechanism that is not known
The goal of this protocol is to determine whether gadofosveset has value in planning catheter trajectories in totally occluded peripheral arteries We propose to study the gadofosveset contrast enhancement patterns in occluded peripheral artery segments in up to 20 patients with known occluded iliac femoral and shoulder arteries being considered for catheter-based treatment
This research may have value in planning and conducting minimally invasive treatments using conventional X-ray guidance and possibly in the future using investigational real-time MRI guidance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 07-H-0128 | None | None | None |