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

Conditions

• Steno-occlusive Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• gadopiclenol — DRUG
  Gadopiclenol enhanced-Magnetic Resonance Angiography
• Gadoterate meglumine (Dotarem) — DRUG
  Gadoterate meglumine (Dotarem) enhanced-Magnetic Resonance Angiography

Study Details

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

Key Dates

First listed

Jan 16, 2026

Start date

Jul 28, 2026

Status verified

Aug 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

315 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Arms

• Experimental: AB
  Gadopiclenol administered first followed by Gadoterate meglumine 0.1 mmol/kg
• Active Comparator: BA
  Gadoterate meglumine 0.1 mmol/kg administered first followed by Gadopiclenol

Primary Outcome Measure

Non-inferiority [ Time Frame: 30 days ]

Central Contacts

• Sophie Rollin, PhD
  +33688196716
  [email protected]
• Frantz Hébert, MSc
  [email protected]

Locations (6)

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