Clinical trial NCT05377775: Mesh Stents Study in ILIAC Complex Lesions (IMS-Study)
Official title: Mesh Stents Study in Iliac Complex Lesions Iliac-Mesh Stent Study (IMS-Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2022-05-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, single-center, open-label, single-arm, non-randomized clinical trial.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: MACNE (Major Adverse Cardiac or Neurological Event )
timeFrame: 48 hours after procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Medical Universtity of Warsaw
state: Mazowieckie
Study officials:
affiliation: Medical University of Warsaw
name: Piotr Myrcha, Ass.Prof.
role: PRINCIPAL_INVESTIGATOR
References: