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Peripheral Arterial Occlusive DiseasePhase 4NCT00717639

Vasovist Magnetic Resonance Angiography (MRA) in Peripheral Arterial Occlusive Disease

A Phase 4 study testing Diagnostic MR-Angiography in people with Peripheral Arterial Occlusive Disease, run by Heidelberg University at 2 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study aims at investigating the diagnostic accuracy of magnetic resonance angiography using the contrast agent Vasovist® in the detection of relevant vascular narrowing of the lower extremity. Patients who have been scheduled for intra-arterial conventional angiography are eligible for this trial. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Peripheral Arterial Occlusive Disease
What is being tested?
Diagnostic MR-Angiography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
2 sitesGermany
Study dates
May 2008to Jul 2010
Phase
Phase 4
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 who have Fontaine-stage III and IV and an indication for therapeutic i.a. DSA
  • PAOD has to be confirmed by ECCM MRA, CTA, non-selective DSA, Doppler ultrasound (DUS) prior to the study.
  • Patients who are willing to undergo the study MRA procedure with Vasovist
  • Patients who are willing to comply with the study procedures (e.g. being followed-up for 12 hours after the Vasovist injection).
  • Patients who have given their fully informed and written consent voluntarily.

Who cannot join

  • Being less than 18 years of age.
  • Women who are pregnant, lactating or who are of childbearing potential and have not had a negative urine pregnancy test the same day as administration of Vasovist. The manufacturer's instructions for performing the urinary pregnancy test are to be followed.
  • Patients who are scheduled for any therapy between any of the two procedures (MRA and DSA) that interferes with the comparability of the two angiographic procedures.
  • Having an underlying disease or concomitant medication which may interfere with efficacy or safety evaluations as planned in this study.
  • Having any physical or mental status that interferes with the informed consent procedure including self-signed consent.
  • GFR < 30 ml/m²/1.73m² (MDRD), values ≤ 1 week or patients on hemodialysis
Show all 18Show fewer
  • Renal or liver transplant patients, including patients with scheduled liver transplant are excluded due to the potential risk for nephrogenic systemic fibrosis (NSF).
  • MR contraindications (pacemaker, magnetic clips, severe claustrophobia)
  • Known allergy to Gadofosveset
  • Presenting with history of anaphylactoid or anaphylactic reaction to any allergen including drugs and contrast agents.
  • Untreated significant stenosis in pelvis
  • Known severe coagulopathy (PTT > 25s, Quick < 60%)
  • Having received any investigational drug within 7 days prior to entering this study or who are planned to receive any investigational drug during the safety follow-up period.
  • Not being able to remain lying down for at least 30-45 min (e.g. patients with unstable angina, dyspnea at rest, severe pain at rest, severe back pain).
  • Being clinically unstable and whose clinical course during the 12 hours observation period is unpredictable.
  • Being scheduled for, or likely to require, any surgical intervention within 12 hours before or within the follow-up period.
  • Patients in whom i.a. DSA is contra-indicated preventing him/her from undergoing standard of reference (SOR) procedure.
  • Close affiliation with the investigational site; e.g. a close relative of the investigator.

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • University Medical Center Mannheim

    Mannheim, 68167

  • University of Munich

    Munich, 81377

Other trials in Germany

About this study

Official title: Determination of Diagnostic Accuracy and Added Value of Vasovist®-Enhanced Peripheral MRA in Comparison to Intra-arterial Digital Subtraction Angiography (i.a. DSA) in Patients With Peripheral Artery Disease

This study aims at investigating the diagnostic accuracy of magnetic resonance angiography using the contrast agent Vasovist® in the detection of relevant vascular narrowing of the lower extremity. Patients who have been scheduled for intra-arterial conventional angiography are eligible for this trial.

Read the detailed description

Patients will only be included into the study if either MRA with extracellular contrast agents, computed tomography angiography, ultrasound or i.a. DSA have been performed beforehand and if the patient has been scheduled for an i.a. DSA to be performed. Vasovist® enhanced MRA imaging will be performed using a state-of-the-art 1.5T MR system. Recruitment, baseline examinations, Vasovist®-enhanced MRA of the vessel segments of interest and follow-up examinations will be performed in up to 8 radiological clinics in Europe. The safety follow-up period will be at least 12 hours but not more than 24 hours post injection of Vasovist® and includes the assessment of physical examinations and vital signs as well as the assessment of AEs. DSA must be carried out at least 12 hours after Vasovist® administration and only after the last follow-up visit has been performed.

Being tested
Diagnostic MR-Angiography
Keywords
diagnostic accuracy, magnetic resonance angiography, steady state, digital subtraction angiography, peripheral arteries
Medical subject headings
Peripheral Arterial Occlusive Disease 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diagnostic MR-AngiographyProcedure or surgery

    Also called Vasovist(R), generic name - gadofosveset

    Single MR-Angiography of the lower extremity after the bolus injection 0.03mmol/kg BW Vasovist

Study groups in NCT00717639
Study groupRoleWhat they receive
1Experimentalsingle arm study, all patients will undergo Vasovist-enhanced MRA
Receives: Procedure: Diagnostic MR-Angiography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Accuracy of quantitative stenosis grading (<50%, >=50%) of Vasovist enhanced MRA with regard to i.a. DSA as standard of reference

    Measured: End of study (anticipated Sep 2009)

Secondary outcomes (7)

  1. Proportion of correct stenosis gradings (<50%, 50-99%, occlusion) of Vasovist® enhanced MRA compared to DSA

    Measured: End of study

  2. Sensitivity and specificity (<50%, >=50%) of Vasovist enhanced MRA compared to DSA

    Measured: End of study

  3. Length of stenosis (target) of Vasovist® enhanced MRA compared to DSA

    Measured: End of study

  4. Correlation of the description of the inflow, target, outflow of Vasovist® enhanced MRA (combined) compared to DSA

    Measured: End of study

  5. Diagnostic value (detection of target lesion y/n) of time-resolved first pass MRA in comparison to high-spatial resolution steady state MRA

    Measured: End of study

  6. Additional venous pathologies

    Measured: End of study

  7. Diagnostic confidence of Vasovist enhanced MRA and DSA

    Measured: End of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2008 (estimated)
  2. Study startMay 2008
  3. Primary completionJul 2010
  4. Study completionJul 2010

Why it stopped: Required contrast media (Vasovist) withdrawn from market

Resources

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 4
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00717639
Sponsor's protocol ID
Vasovist MA-01
Other IDs
EudraCT 2007-006014-41
Status last verified
Jul 2010
First submitted
30 Jun 2008
Last updated
8 Aug 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Diagnostic MR-Angiography in people with Peripheral Arterial Occlusive Disease, run by Heidelberg University at 2 sites in Germany.

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 18 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: stopped early, as of the sponsor's last update on 8 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 was stopped early (reason given: Required contrast media (Vasovist) withdrawn from market). Results are not available in the source record.

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.

What does the primary outcome measure?

Accuracy of quantitative stenosis grading (<50%, >=50%) of Vasovist enhanced MRA with regard to i.a. DSA as standard of reference (time frame: End of study (anticipated Sep 2009)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00717639.

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 8 Aug 2011.

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