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NCT00094783 · ClinicalTrials.gov registry record · Phase 1
MRI-Guided Balloon Angioplasty to Treat Blood Flow Blockage in the Legs
A Phase 1 study of Cardiovascular Diseases, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT00094783 is a Phase 1 study of Cardiovascular Diseases that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 24 participants, below the 26,974-participant average among 300 other Cardiovascular Diseases trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00094783, a Phase 1 study of Cardiovascular Diseases, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will examine the use of magnetic resonance imaging (MRI) instead of x-rays to guide angioplasty in patients who require these treatments to treat blockages in leg arteries. Angioplasty is a procedure in which a balloon is inflated in a blocked artery to improve blood flow. MRI uses a magnetic field and radio waves rather than x-rays to show pictures of body tissues and organs. MRI shows all soft tissue, including the arteries, blood, and other organs, while the usual x-ray technique shows only the lumen of the artery when it is filled with dye, but not the vessel walls. Patients 18 years of age and older who require angioplasty with or without stenting to restore blood flow to the leg may be eligible for this study. Participants undergo the usual angioplasty procedure. The skin in the patient's groin area is numbed and a catheter is placed into the groin artery. The patient is given a blood-thinning medicine, and then other catheters are inserted to measure blood pressure and to inject a contrast dye to take pictures. Balloon catheters are inflated to open the blockage and, if needed, stents are put in place to maintain the opening. When the blood thinner wears off, the catheters are removed. Most of the procedure is conducted using MRI instead of X-rays to visualize the arteries and blockages. The patient is moved back and forth between the x-ray and MRI machines in a specially designed laboratory. If necessary, stenting, placement of a wire mesh to hold open the artery, is done using conventional x-ray techniques. The entire procedure, including MRI, takes up to 4 hours.
Conditions Studied
Interventions
- PROCEDURE MRI
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2004-10-20 |
| Est. Completion | 2008-06-17 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00094783
The ClinicalTrials.gov registry entry for NCT00094783 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 26,974-participant average among 300 other Cardiovascular Diseases trials with a reported enrollment target (100% lower). The listed sponsor is National Heart, Lung, and Blood Institute (NHLBI), which has 501 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Cardiovascular Diseases appearing as the primary indexed condition, and to 1 intervention - of which MRI is the first listed.
NCT00094783 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00094783 about?
NCT00094783 is a clinical study titled "MRI-Guided Balloon Angioplasty to Treat Blood Flow Blockage in the Legs". This study will examine the use of magnetic resonance imaging (MRI) instead of x-rays to guide angioplasty in patients who require these treatments to treat blockages in leg arteries. Angioplasty is a procedure in which a balloon is inflated in a blocked artery to improve blood flow. MRI uses a magn...
What is the current status of trial NCT00094783?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2004-10-20. Estimated completion is 2008-06-17.
What conditions does trial NCT00094783 study?
This clinical trial studies the following conditions: Cardiovascular Diseases.
What interventions are being tested in trial NCT00094783?
The interventions under investigation include: MRI (PROCEDURE).
Who is sponsoring clinical trial NCT00094783?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00094783 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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