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

Primary Purpose

Peripheral Arterial Disease, Iliac Artery Stenosis, Embolus Arterial

Status
Not yet recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Iliac Stenting
Sponsored by
Medical University of Warsaw
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring Iliac artery stenosis, High-risk plague, Mesh stent, Peripheral embolisation, Peripheral arterial disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical Universtity of Warsaw

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Conventional Implantation of mesh stent

Arm Description

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

Outcomes

Primary Outcome Measures

MACNE (Major Adverse Cardiac or Neurological Event )
In-hospital MACNE (death, stroke, myocardial infarction, acute limb or target organ ischemia)

Secondary Outcome Measures

Full Information

First Posted
April 29, 2022
Last Updated
May 16, 2022
Sponsor
Medical University of Warsaw
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1. Study Identification

Unique Protocol Identification Number
NCT05377775
Brief Title
Mesh Stents Study in ILIAC Complex Lesions (IMS-Study)
Acronym
IMS
Official Title
Mesh Stents Study in Iliac Complex Lesions Iliac-Mesh Stent Study (IMS-Study)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 10, 2022 (Anticipated)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Warsaw

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease, Iliac Artery Stenosis, Embolus Arterial, Ischemic Leg
Keywords
Iliac artery stenosis, High-risk plague, Mesh stent, Peripheral embolisation, Peripheral arterial disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, single-center, open-label, single-arm, non-randomized clinical trial.
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional Implantation of mesh stent
Arm Type
Experimental
Arm Description
Conventional Implantation of mesh stent in iliac stenosis with high-risk plaques
Intervention Type
Device
Intervention Name(s)
Iliac Stenting
Intervention Description
Conventional Implantation of mesh stent in iliac stenosis with high-risk plaques
Primary Outcome Measure Information:
Title
MACNE (Major Adverse Cardiac or Neurological Event )
Description
In-hospital MACNE (death, stroke, myocardial infarction, acute limb or target organ ischemia)
Time Frame
48 hours after procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Piotr Myrcha, MD, PhD
Phone
+48 607 366 683
Email
piotrmyr@poczta.fm
First Name & Middle Initial & Last Name or Official Title & Degree
Izabela Taranta, PhD
Phone
0048‭508190957‬
Email
iza.taranta@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Piotr Myrcha, Ass.Prof.
Organizational Affiliation
Medical University of Warsaw
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Universtity of Warsaw
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
03-242
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/30266356/
Description
Randomized trial comparing CGuard™ stent vs. Wallstent™
URL
https://pubmed.ncbi.nlm.nih.gov/33855877/
Description
Thirty-Day Results of the Novel CGuard-Covered Stent in Patients Undergoing Carotid Artery Stenting
URL
https://pubmed.ncbi.nlm.nih.gov/31060430/
Description
CGuard MicroNet-Covered "One-Size-Fits-All" Carotid Stent
URL
https://pubmed.ncbi.nlm.nih.gov/34391704/
Description
The IRONGUARD 2 Study
URL
https://pubmed.ncbi.nlm.nih.gov/30945420/
Description
Analysis from the PARADIGM study

Learn more about this trial

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

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