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 version

Guideline on clinical investigation of medicinal products for the treatment of peripheral arterial occlusive disease of the lower extremities

Adopted Reference Number: EMA/369563/2025 Rev. 2 Legal effective date: 30/06/2026

Overview of comments received on guideline on clinical investigation of medicinal products for the treatment of peripheral arterial occlusive disease of the lower extremities

Reference Number: EMA/372496/2025

Document history

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

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

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

Adopted Reference Number: CPMP/EWP/714/98 rev1 Legal 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 closed Consultation dates: 12/11/2018 to 30/06/2019 Reference Number: EMA/CHMP/78339/2018