Status:
UNKNOWN
Mesh Stents Study in ILIAC Complex Lesions (IMS-Study)
Lead Sponsor:
Medical University of Warsaw
Conditions:
Peripheral Arterial Disease
Iliac Artery Stenosis
Eligibility:
All Genders
18+ years
Phase:
NA
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 contai...
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 occlus...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05377775
Start Date
June 10 2022
End Date
December 31 2024
Last Update
May 17 2022
Active Locations (1)
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1
Medical Universtity of Warsaw
Warsaw, Masovian Voivodeship, Poland, 03-242