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Completed

NCT Number: NCT01026389

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

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.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

AKH hospital

Vienna, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DOTAREM

Drug

DOTAREM, 0.1 mmoL/kg (0.2 mL/kg), intravenous (I.V.) bolus

Other names: gadoterate, Gd-Dota

Gadovist

Drug

Gadovist, 0.1mmol/kg (0.1mL/kg), intravenous (I.V.) bolus

Other names: gadobutrol

Primary outcomes

  1. Intra-patient Accuracy (Percent Agreement), On-site Data

    Time frame: 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 outcomes

  1. Intra-patient Accuracy, in Off-site Readings

    Time frame: 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

  2. Specificity

    Time frame: 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).

  3. Sensitivity

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Guerbet

Industry

Registry information

Official study title

Efficacy Evaluation of Dotarem®-Enhanced MRA Compared to Gadovist®-Enhanced MRA in the Diagnosis of Clinically Significant Abdominal or Limb Arterial Diseases

Acronym: DALIA

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Dec 4, 2009
Registry last updated
Dec 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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