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

NCT00717639 | Terminated Phase 4

• 2 other identifiers: Vasovist MA-01EudraCT 2007-006014-41
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Peripheral Arterial Occlusive Disease

Keywords

diagnostic accuracy; magnetic resonance angiography; steady state; digital subtraction angiography; peripheral arteries

Outcome Measures

Primary Outcomes (1)

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

  End of study (anticipated Sep 2009)

Secondary Outcomes (7)

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

  End of study

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

  End of study

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

  End of study

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

  End of study

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

  End of study

Study Arms (1)

1

EXPERIMENTAL

single arm study, all patients will undergo Vasovist-enhanced MRA

Procedure: Diagnostic MR-Angiography

Interventions

Diagnostic MR-Angiography PROCEDURE

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

Also known as: Vasovist(R), generic name - gadofosveset

1

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Heidelberg University: lead

Study Sites (2)

University Medical Center Mannheim

Mannheim, 68167, Germany

Location

University of Munich

Munich, 81377, Germany

Location

MeSH Terms

Conditions

Peripheral Arterial Occlusive Disease 1

Study Officials

• Henrik J Michaely, MD

  Heidelberg University

  PRINCIPAL INVESTIGATOR

• Stefan O Schoenberg, MD

  Heidelberg University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 30, 2008
• First Posted: July 17, 2008
• Study Start: May 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: August 8, 2011

Record last verified: 2010-07

Locations

DE (2)