Efficacy Evaluation of Dotarem Compared to Gadovist in the Diagnosis of Peripheral Arterial Disease

Phase 4

Completed

• Conditions: Peripheral Arterial Disease
• Interventions: Drug: Gadovist; Drug: Dotarem

• Registration Number: NCT01026389
• Lead Sponsor: Guerbet

Brief Summary

This study is an efficacy evaluation of Dotarem®-enhanced magnetic resonance angiography (MRA) compared to Gadovist®-enhanced MRA in the diagnosis of clinically significant abdominal or lower limb arterial diseases.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-12-03
• Study First Submitted QC: 2009-12-03
• Study First Posted: 2009-12-04
• Primary Completion: 2011-06
• Study Completion: 2012-01
• Status Verified: 2012-11
• Results First Submitted: 2012-11-14
• Results First Submitted QC: 2012-11-14
• Last Update Submitted: 2012-11-14
• Results First Posted: 2012-12-11
• Last Update Posted: 2012-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 189

Inclusion Criteria

• Male or female, aged ≥ 18 years.
• Patient with infrarenal aorta or chronic lower limb ischemia with various clinical signs of gravity (stages II-IV according to the classification of Leriche and Fontaine) or/and Doppler ultrasonography indicating abdominal or lower limb arteriopathy.
• Patient scheduled for a conventional X-Ray angiography (intra-arterial Digital Substraction Angiography = DSA) within 30 days of MRA with a minimum time interval of at least 24 hours between the 2 examinations.

Exclusion Criteria

• Patient planned to undergo therapeutic intervention in abdominal or lower limb vessels between the time of MRA and X-ray Angiography will be performed.
• Patient who had a major cardiovascular event within 30 days prior to the inclusion.
• Patient treated with unilateral hip replacement, abdominal aortic or iliac graft or stent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gadovist	Gadovist	Patient received contrast-enhanced MRA with Gadovist
Dotarem, interventional	Dotarem	Patients received contrast-enhanced MRA with Dotarem

Primary Outcome Measures

Name	Time	Method
Intra-patient Accuracy (Percent Agreement), On-site Data	up to one month	intra-patient accuracy (percent agreement) of each type of MRA examination (Dotarem® or Gadovist®-enhanced MRA) in assessing the lesions of the concerned territory as compared with the gold standard, X-ray angiography.

Secondary Outcome Measures

Name	Time	Method
Intra-patient Accuracy, in Off-site Readings	up to one month	• Intra-patient accuracy (percent agreement) of each type of MRA examination (Dotarem® or Gadovist®-enhanced MRA) in assessing the lesions of the concerned territory as compared with the gold standard, X-ray angiography, in off-site readings, using the same methodology as that used for the primary criterion
Specificity	up to one month	Specificity of Dotarem® and Gadovist®-enhanced MRA examinations at the segment and the patient levels (gold standard = x-ray angiography) in on-site readings; no stenosis and non significant stenosis were grouped as one class (non significant stenosis = negative segment).
Sensitivity	up to one month	sensitivity of Dotarem® and Gadovist®-enhanced MRA examinations at the segment and the patient levels (gold standard = x-ray angiography) in on-site; moderate, severe stenosis and occlusion were grouped as one class (significant stenosis = positive segment).

Trial Locations

Locations (1)

AKH hospital; 🇦🇹 Wien, Austria