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

Not Applicable

Not yet recruiting

• Conditions: Embolus Arterial; Peripheral Arterial Disease; Iliac Artery Stenosis; Ischemic Leg
• Interventions: Device: Iliac Stenting

• Registration Number: NCT05377775
• Lead Sponsor: Medical University of Warsaw

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.

Study Timeline

• Status Verified: 2022-04
• Study First Submitted: 2022-04-29
• Study First Submitted QC: 2022-05-16
• Last Update Submitted: 2022-05-16
• Study First Posted: 2022-05-17
• Last Update Posted: 2022-05-17
• Study Start: 2022-06-10
• Primary Completion: 2024-10-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Conventional Implantation of mesh stent	Iliac Stenting	Conventional Implantation of mesh stent in iliac stenosis with high-risk plaques

Primary Outcome Measures

Name	Time	Method
MACNE (Major Adverse Cardiac or Neurological Event )	48 hours after procedure	In-hospital MACNE (death, stroke, myocardial infarction, acute limb or target organ ischemia)

Trial Locations

Locations (1)

Medical Universtity of Warsaw; 🇵🇱 Warsaw, Mazowieckie, Poland