Mesh Stents Study in ILIAC Complex Lesions (IMS-Study) (NCT05377775) | Clinical Trial Compass
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Mesh Stents Study in ILIAC Complex Lesions (IMS-Study)
Poland50 participantsStarted 2022-06-10
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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
What they're measuring
1
MACNE (Major Adverse Cardiac or Neurological Event )