Clinical investigation of medicinal products in the treatment of peripheral-arterial occlusive disease - Scientific guideline

This guideline provides guidance on the evaluation of medicinal products in the treatment of chronic peripheral arterial occlusive disease.

Keywords: Peripheral Arterial Occlusive Disease (PAOD),  Lower extremity artery disease (LEAD), Chronic Limb Threatening Ischaemia (CLTI), Atherosclerosis

Current effective version

Draft guideline on clinical investigation of medicinal products for the treatment of peripheral arterial occlusive disease of the lower extremities - Revision 2

Draft: consultation closedConsultation dates: 31/10/2024 to 30/04/2025Reference Number: EMA/CHMP/464798/2024 Rev. 2 (previously EMA/CHMP/464798/2024 Rev. 1)Summary:

This guideline replaces Note for Guidance on clinical investigation of medicinal products for the 10 treatment of peripheral arterial occlusive disease (CPMP/EWP/714/98 rev 1).

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Document history

Note for guidance on clinical investigation of medicinal products for the treatment of peripheral arterial occlusive disease

AdoptedReference Number: CPMP/EWP/714/98 rev1Legal effective date: 01/10/2002

Concept paper on the need for revision of the Note for Guidance on Clinical Investigation of Medicinal Products for the Treatment of Peripheral Arterial Occlusive Disease (CHMP/EWP/714/98 rev 1)

Draft: consultation closedConsultation dates: 12/11/2018 to 30/06/2019Reference Number: EMA/CHMP/78339/2018