Embolus Arterial, Iliac Artery Stenosis, Ischemic Leg, Peripheral Arterial Disease
Conditions
Keywords
Iliac artery stenosis, High-risk plague, Mesh stent, Peripheral embolisation, Peripheral arterial disease
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.
Interventions
DEVICEIliac Stenting
Conventional Implantation of mesh stent in iliac stenosis with high-risk plaques
Sponsors
Medical University of Warsaw
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, single-center, open-label, single-arm, non-randomized clinical trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MACNE (Major Adverse Cardiac or Neurological Event ) | 48 hours after procedure | In-hospital MACNE (death, stroke, myocardial infarction, acute limb or target organ ischemia) |
Countries
Poland
Contacts
Primary ContactPiotr Myrcha, MD, PhD
Backup ContactIzabela Taranta, PhD
Outcome results
None listed