NCT05377775

Mesh Stents Study in ILIAC Complex Lesions (IMS-Study)

Mesh Stents Study in Iliac Complex Lesions Iliac-Mesh Stent Study (IMS-Study)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Medical University of Warsaw · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main objective of the IMS-Study is to evaluate the short and long-term safety and efficacy of mesh stent implantation in patients with stenotic iliac disease with complex plaques or lesions containing thrombotic material.

Detailed description

Iliac artery disease may include complex lesions with a vulnerable plaque and containing thrombotic materials. The treatment of these complex plaques is frequently complicated with local, acute occlusion, dissection and distal embolisation. Studies with a mesh stent in the carotid region have shown a reduced risk of peripheral embolization. The use of mesh stents in iliac arteries can provide similar benefits. The structure of the stents, sizes, and the release system do not require any changes. The study is to assess the usefulness of mesh stents in preventing peripheral embolisation.

Conditions

• Peripheral Arterial Disease
• Iliac Artery Stenosis
• Embolus Arterial
• Ischemic Leg

Interventions

Type	Name	Description
DEVICE	Iliac Stenting	Conventional Implantation of mesh stent in iliac stenosis with high-risk plaques

Timeline

• Start date: 2022-06-10
• Primary completion: 2024-10-31
• Completion: 2024-12-31
• First posted: 2022-05-17
• Last updated: 2022-05-17

Locations

1 site across 1 country: Poland