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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-10

Study Completion Date

2024-12-31

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.

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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.

Conditions

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Peripheral Arterial Disease Iliac Artery Stenosis Embolus Arterial Ischemic Leg

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective, single-center, open-label, single-arm, non-randomized clinical trial.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Conventional Implantation of mesh stent

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

Group Type EXPERIMENTAL

Iliac Stenting

Intervention Type DEVICE

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

Interventions

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Iliac Stenting

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

* 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)

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No