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

NCT05377775 | Unknown

• 1 other identifier: WarsawMU IMS v.01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Disease; Iliac Artery Stenosis; Embolus Arterial; Ischemic Leg

Keywords

Iliac artery stenosis; High-risk plague; Mesh stent; Peripheral embolisation; Peripheral arterial disease

Outcome Measures

Primary Outcomes (1)

• MACNE (Major Adverse Cardiac or Neurological Event )

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

  48 hours after procedure

Study Arms (1)

Conventional Implantation of mesh stent

EXPERIMENTAL

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

Device: Iliac Stenting

Interventions

Iliac Stenting DEVICE

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

Conventional Implantation of mesh stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Medical Universtity of Warsaw

Warsaw, Masovian Voivodeship, 03-242, Poland

Location

Related 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

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Piotr Myrcha, Ass.Prof.

  Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Piotr Myrcha, MD, PhD

CONTACT

+48 607 366 683; piotrmyr@poczta.fm

Izabela Taranta, PhD

CONTACT

0048‭508190957‬; iza.taranta@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: April 29, 2022
• First Posted: May 17, 2022
• Study Start: June 10, 2022
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 17, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)