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

Peripheral Arterial Disease Clinical Trial

— IMS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05377775
• Other study ID #: WarsawMU IMS v.01
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 10, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2022
• Source: Medical University of Warsaw
• Contact: Piotr Myrcha, MD, PhD
• Phone: +48 607 366 683
• Email: piotrmyr[@]poczta.fm
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Iliac Artery Stenosis
• Ischemic Leg
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• Iliac Stenting
Conventional Implantation of mesh stent in iliac stenosis with high-risk plaques

Locations

Country	Name	City	State
Poland	Medical Universtity of Warsaw	Warsaw	Mazowieckie

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MACNE (Major Adverse Cardiac or Neurological Event )	In-hospital MACNE (death, stroke, myocardial infarction, acute limb or target organ ischemia)	48 hours after procedure

External Links

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