Cardiovascular DiseasesPhase 1NCT00094783
MRI-Guided Balloon Angioplasty to Treat Blood Flow Blockage in the Legs
A Phase 1 study testing MRI in people with Cardiovascular Diseases, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- MRI
- Type of treatment
- Surgery or procedure
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2004to 17 Jun 2008
- Phase
- Phase 1
- 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
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Real-Time MRI-Guided Percutaneous Intervention for Aorto-illac and Femoropopliteal, Artery Stenosis
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.
Read more
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.
Read the detailed description
Cardiovascular interventional procedures are minimally-invasive, catheter-based treatments such as coronary artery angioplasty and stenting. These procedures generally can be conducted on awake patients with few complications, and were developed as alternatives to conventional open surgery. Conventional cardiovascular interventional procedures are conducted by physician manipulating medical devices inside patients under the guidance of fluoroscopic x-ray.
We have developed minimally-invasive cardiovascular interventional procedures using real-time magnetic resonance imaging. These procedures have the advantage of excellent imaging without surgery and without ionizing radiation exposure or toxic contrast agents (dyes). Moreover, because real time MRI can produce excellent images of soft tissue, blood, and of three-dimensional structures, it may be possible to guide minimally-invasive procedures not possible even with invasive surgery.
A state-of-the-art combined X-ray and MRI interventional suite has been constructed and equipped with real-time MRI image reconstruction for interventional experiments, patient monitoring and transport equipment for dual imaging modalities, and large-mammal preclinical simulation experiments. Preclinical experiments in a porcine model of surgical aortic coarctation have shown that real-time MRI guided percutaneous intervention can be conducted using entirely commercially-available devices approved by the US Food and Drug Administration.
The goal of this protocol is to test clinical peripheral artery revascularization procedures guided wholly-or in part by real-time MRI.
- Conditions
- Cardiovascular Diseases
- Being tested
- MRI
- Keywords
- Magnetic Resonance Imaging, Interventional MRI, Arterial Stenosis, Revascularization, Lllac Artery Stenosis, Peripheral Arterial Disease, Cardiovascular Disease
- Medical subject headings
- Cardiovascular Diseases, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2004 (estimated)
- Study start20 Oct 2004
- Study completion17 Jun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Enrolment
- 24 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00094783
- Sponsor's protocol ID
- 050007
- Other IDs
- 05-H-0007
- Status last verified
- 17 Jun 2008
- First submitted
- 22 Oct 2004
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
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.
PubMed 12549231
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-Time MRI-Guided Percutaneous Intervention for Aorto-illac and Femoropopliteal, Artery Stenosis
- ClinicalTrials.gov ID
- NCT00094783
- Acronym / sponsor ID
- 050007
- Conditions
- Cardiovascular Diseases
- Keywords
- Magnetic Resonance Imaging, Interventional MRI, Arterial Stenosis, Revascularization, Lllac Artery Stenosis, Peripheral Arterial Disease, Cardiovascular Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 20 Oct 2004
- Study completion
- 17 Jun 2008
- First posted
- 25 Oct 2004 (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 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.
Detailed description
Cardiovascular interventional procedures are minimally-invasive, catheter-based treatments such as coronary artery angioplasty and stenting. These procedures generally can be conducted on awake patients with few complications, and were developed as alternatives to conventional open surgery. Conventional cardiovascular interventional procedures are conducted by physician manipulating medical devices inside patients under the guidance of fluoroscopic x-ray.
We have developed minimally-invasive cardiovascular interventional procedures using real-time magnetic resonance imaging. These procedures have the advantage of excellent imaging without surgery and without ionizing radiation exposure or toxic contrast agents (dyes). Moreover, because real time MRI can produce excellent images of soft tissue, blood, and of three-dimensional structures, it may be possible to guide minimally-invasive procedures not possible even with invasive surgery.
A state-of-the-art combined X-ray and MRI interventional suite has been constructed and equipped with real-time MRI image reconstruction for interventional experiments, patient monitoring and transport equipment for dual imaging modalities, and large-mammal preclinical simulation experiments. Preclinical experiments in a porcine model of surgical aortic coarctation have shown that real-time MRI guided percutaneous intervention can be conducted using entirely commercially-available devices approved by the US Food and Drug Administration.
The goal of this protocol is to test clinical peripheral artery revascularization procedures guided wholly-or in part by real-time MRI.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
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 |
|---|---|---|
| MRI | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 2 Jul 2017.
- Background: PubMed 12549231Guttman 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MRI in people with Cardiovascular Diseases, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site 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 5 inclusion and 8 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 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00094783, which also lists 1 linked publication.
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 2 Jul 2017.