Peripheral Arterial Disease Clinical Trial
— IMSOfficial title:
Mesh Stents Study in Iliac Complex Lesions Iliac-Mesh Stent Study (IMS-Study)
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.
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 |
Country | Name | City | State |
---|---|---|---|
Poland | Medical Universtity of Warsaw | Warsaw | Mazowieckie |
Lead Sponsor | Collaborator |
---|---|
Medical University of Warsaw |
Poland,
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 |
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