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

Medical University of Warsaw50 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Peripheral Arterial Disease Iliac Artery Stenosis Embolus Arterial Ischemic Leg

Interventions

Iliac StentingDEVICE

Conventional Implantation of mesh stent in iliac stenosis with high-risk plaques

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Medical Universtity of Warsaw

Warsaw, Masovian Voivodeship, Poland

Outcomes

Primary Outcomes

MACNE (Major Adverse Cardiac or Neurological Event )

In-hospital MACNE (death, stroke, myocardial infarction, acute limb or target organ ischemia)

Time frame: 48 hours after procedure

Central Contacts

Piotr Myrcha, MD, PhD

CONTACT

+48 607 366 683 piotrmyr@poczta.fm

Izabela Taranta, PhD

CONTACT

0048‭508190957‬iza.taranta@gmail.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.