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Evaluation of the Efficacy and Safety of Magnetic Resonance Angiography (MRA) Using Gadopiclenol Compared to Gadoterate Meglumine in the Assessment of Steno-occlusive Disease in Adult Patients With Suspected Vascular Disease

NCT07348640 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 315

Last updated 2026-01-20

No results posted yet for this study

Summary

Compare the diagnostic performance of gadopiclenol against gadoterate meglumine in patients with vascular diseases of supra-aortic, peripheral, or abdominal / renal arteries using MRI

Conditions

  • Steno-occlusive Disease

Interventions

DRUG

Gadoterate meglumine (Dotarem)

Gadoterate meglumine (Dotarem) enhanced-Magnetic Resonance Angiography

DRUG

gadopiclenol

Gadopiclenol enhanced-Magnetic Resonance Angiography

Sponsors & Collaborators

  • Bracco Imaging S.p.A.

    collaborator INDUSTRY

  • Guerbet

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-02
Primary Completion
2027-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Czechia
  • France
  • Germany
  • Hungary
  • Italy
  • Poland
  • South Korea
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07348640 on ClinicalTrials.gov