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

Primary Purpose

Peripheral Arterial Occlusive Disease

Status

Terminated

Phase

Phase 4

Locations

Germany

Study Type

Interventional

Intervention

Diagnostic MR-Angiography

About this trial

This is an interventional diagnostic trial for Peripheral Arterial Occlusive Disease focused on measuring diagnostic accuracy, magnetic resonance angiography, steady state, digital subtraction angiography, peripheral arteries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.
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.

Sites / Locations

University Medical Center Mannheim
University of Munich

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

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

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

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

Additional venous pathologies

Diagnostic confidence of Vasovist enhanced MRA and DSA

Full Information

NCT ID

NCT00717639

First Posted

June 30, 2008

Last Updated

August 5, 2011

Sponsor

Heidelberg University

1. Study Identification

Unique Protocol Identification Number

NCT00717639

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2010

Overall Recruitment Status

Terminated

Why Stopped

Required contrast media (Vasovist) withdrawn from market

Study Start Date

May 2008 (undefined)

Primary Completion Date

July 2010 (Actual)

Study Completion Date

July 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Heidelberg University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Arterial Occlusive Disease

Keywords

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Diagnostic MR-Angiography

Other Intervention Name(s)

Vasovist(R), generic name - gadofosveset

Intervention Description

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

Primary Outcome Measure Information:

Title

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)

Secondary Outcome Measure Information:

Title

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

Time Frame

End of study

Title

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

Time Frame

End of study

Title

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

Time Frame

End of study

Title

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

Time Frame

End of study

Title

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

Time Frame

End of study

Title

Additional venous pathologies

Time Frame

End of study

Title

Diagnostic confidence of Vasovist enhanced MRA and DSA

Time Frame

End of study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Henrik J Michaely, MD

Organizational Affiliation

Heidelberg University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Stefan O Schoenberg, MD

Organizational Affiliation

Heidelberg University

Official's Role

Study Director

Facility Information:

Facility Name

University Medical Center Mannheim

City

Mannheim

ZIP/Postal Code

68167

Country

Germany

Facility Name

University of Munich

City

Munich

ZIP/Postal Code

81377

Country

Germany

12. IPD Sharing Statement

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

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