MRI-Guided Balloon Angioplasty to Treat Blood Flow Blockage in the Legs

NCT00094783 | Completed Phase 1

• 2 other identifiers: 05000705-H-0007
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Cardiovascular Diseases

Keywords

Magnetic Resonance Imaging; Interventional MRI; Arterial Stenosis; Revascularization; Lllac Artery Stenosis; Peripheral Arterial Disease; Cardiovascular Disease

Interventions

MRI PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with known or suspected cardiovascular disease will be eligible for participation in this protocol. The patient is eligible under the following conditions:
• Patients age is greater than 18 years of age.
• Undergoing a clinically-indicated therapeutic peripheral artery catheterization procedure.
• Target peripheral artery is aorto-illac or femoropopliteal artery.
• Target peripheral artery stenoses, not occlusions, evident on magnetic resonance or x-ray angiography.

You may not qualify if:

• Patients with absolute contraindications to MRI scanning will be excluded. These contraindications include patients with the following devices:
• Implanted cardiac pacemaker or defibrillator.
• Central nervous system aneurysm clips.
• Implanted neural stimulator.
• Cochlear implant.
• Ocular foreign body (e.g. metal shavings).
• Insulin pump.
• Metal shrapnel or bullet.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• Guttman MA, Lederman RJ, Sorger JM, McVeigh ER. Real-time volume rendered MRI for interventional guidance. J Cardiovasc Magn Reson. 2002;4(4):431-42. doi: 10.1081/jcmr-120016382.

  PMID: 12549231 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Peripheral Vascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: October 22, 2004
• First Posted: October 25, 2004
• Study Start: October 20, 2004
• Study Completion: June 17, 2008
• Last Updated: July 2, 2017

Record last verified: 2008-06-17

Locations

US (1)