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

NCT01026389 | Completed Phase 4 Results

• 1 other identifier: DGD 44-045
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease

Keywords

MRA-Contrast agent comparison in peripheral disease

Outcome Measures

Primary Outcomes (1)

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

  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.

  up to one month

Secondary Outcomes (3)

• Intra-patient Accuracy, in Off-site Readings

  up to one month

• Specificity

  up to one month

• Sensitivity

  up to one month

Study Arms (2)

Gadovist

ACTIVE COMPARATOR

Patient received contrast-enhanced MRA with Gadovist

Drug: Gadovist

Dotarem, interventional

EXPERIMENTAL

Patients received contrast-enhanced MRA with Dotarem

Drug: Dotarem

Interventions

Dotarem DRUG

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

Also known as: gadoterate, Gd-Dota

Dotarem, interventional

Gadovist DRUG

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

Also known as: gadobutrol

Gadovist

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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 treated with unilateral hip replacement, abdominal aortic or iliac graft or stent.

Sponsors & Collaborators

• Guerbet: lead

Study Sites (1)

AKH hospital

Vienna, Austria

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

gadoterate meglumine; gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate; gadobutrol

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Post M. A. Clinical Unit Manager
• Organization: Guerbet

corinne.dubourdieu@guerbet-group.com

+33 1 45 91 50 00

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2009
• First Posted: December 4, 2009
• Study Start: October 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: January 1, 2012
• Last Updated: December 11, 2012
• Results First Posted: December 11, 2012

Record last verified: 2012-11

Locations

AU (1)