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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Peripheral Arterial Disease; Ischemic Leg; Iliac Artery Stenosis; Embolus Arterial
• Intervention / Treatment: Device: Iliac Stenting

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Piotr Myrcha, MD, PhD; Phone Number: +48 607 366 683; Email: piotrmyr@poczta.fm
• Study Contact Backup: Name: Izabela Taranta, PhD; Phone Number: 0048‭508190957‬; Email: iza.taranta@gmail.com

Study Locations

• Poland
  • Mazowieckie
    • Warsaw, Mazowieckie, Poland, 03-242
      • Medical Universtity of Warsaw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Conventional Implantation of mesh stent; Conventional Implantation of mesh stent in iliac stenosis with high-risk plaques	Device: Iliac Stenting; Conventional Implantation of mesh stent in iliac stenosis with high-risk plaques

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medical University of Warsaw
• Investigators: Principal Investigator: Piotr Myrcha, Ass.Prof., Medical University of Warsaw

Publications and helpful links

Helpful Links

• Randomized trial comparing CGuard™ stent vs. Wallstent™
• Thirty-Day Results of the Novel CGuard-Covered Stent in Patients Undergoing Carotid Artery Stenting
• CGuard MicroNet-Covered "One-Size-Fits-All" Carotid Stent
• The IRONGUARD 2 Study
• Analysis from the PARADIGM study

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 10, 2022
• Primary Completion (ANTICIPATED): October 31, 2024
• Study Completion (ANTICIPATED): December 31, 2024

Study Registration Dates

• First Submitted: April 29, 2022
• First Submitted That Met QC Criteria: May 16, 2022
• First Posted (ACTUAL): May 17, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 17, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Peripheral arterial disease; Iliac artery stenosis; High-risk plague; Mesh stent; Peripheral embolisation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: WarsawMU IMS v.01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No