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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Peripheral Arterial Disease, Iliac Artery Stenosis, Embolus Arterial, Ischemic Leg

Intervention / Treatment
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* Device: Iliac Stenting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: General Inclusion Criteria (principal): Patients older than 18 years, after Vascular Team evaluation, according to local standards, eligible for Iliac artery Written, informed consent to participate Agreement to attend Protocol required (standard) follow up visits and examinations Angiographic Inclusion Criteria (principal): De novo iliac stenosis Stenosis eligible for endovascular treatment per Vascular Team evaluation (according to current standards and guidelines) High-risk morphology stenosis with complex/thrombotic lesions (per 1 independent, experienced operator). Exclusion Criteria: General Exclusion Criteria (principal): Life expectancy <1 year (e.g., active neoplastic disease). Chronic kidney disease with creatinine > 3.0 mg/dL. Coagulopathy. Contraindication for decoagulation History of uncontrolled contrast media intolerance Myocardial infarction in 72 hours preceding the stenting procedure (if possible, postponing the procedure) Stroke in 6 weeks preceding the stenting procedure (if possible, postponing the procedure) Pregnancy (positive pregnancy test) AngiographicExclusion Criteria (principal): Chronic total occlusion not amenable to re-canalization Stent in the target vessel/lesion Anatomic variants precluding stent implantation Mobile (free-floating) plaque elements in aorta or arteries proximal to the target lesion

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, single-center, open-label, single-arm, non-randomized clinical trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conventional Implantation of mesh stent<br>Conventional Implantation of mesh stent in iliac stenosis with high-risk plaques | Device: Iliac Stenting<br>* Conventional Implantation of mesh stent in iliac stenosis with high-risk plaques<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACNE (Major Adverse Cardiac or Neurological Event ) | In-hospital MACNE (death, stroke, myocardial infarction, acute limb or target organ ischemia) | 48 hours after procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Iliac artery stenosis, High-risk plague, Mesh stent, Peripheral embolisation, Peripheral arterial disease