Peripheral Vascular Diseases
Conditions
Brief summary
Prospective observational study of MicroNet covered stent implantation in the elevated risk peripheral lesions (high lesion load, thrombus containing, highly calcified). Open-label, non randomized, single arm observational study. Jagiellonian University Medical College research project.
Detailed description
Peripheral artery stents in routine use (both balloon expandable and self-expendable) do not sufficiently prevent distal embolization. They might induce a cheese-grater effect - a consequence of their single layer design with uncovered space between stent struts. Aim of the study is to evaluate short and long term safety and efficacy of MicroNet covered stent implantation in the high risk lesions beyond the carotid bifurcation. Treatment eligibility will be evaluated by a Vascular Team process (angiologist, vascular surgeon, cardiologist). Optimal pharmacotherapy will be administered according to the current guidelines. Symptomatic and asymptomatic patients with peripheral artery disease requiring endovascular treatment for high risk stenosis (soft plaque, highly calcific plaque) per Vascular Team assessment. A group of 30-50 consecutive patients meeting inclusion and exclusion criteria will be enrolled.
Interventions
DEVICEMicroNet covered stent implantation in the increased risk arterial lesions beyond the carotid bifurcation
Implantation of the MicroNet covered stent in the increased risk arterial lesions beyond the carotid bifurcation as per Vascular Team recommendation
Sponsors
John Paul II Hospital, Krakow
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
General Inclusion Criteria: * Patients older than 18 years, eligible for peripheral artery stenting after Vascular Team evaluation, according to local standards * Written, informed consent to participate * Agreement to attend protocol required (standard) follow up visits and examinations
Exclusion criteria
* Life expectancy \<1 year (e.g. active neoplastic disease). * Chronic kidney disease with creatinine \> 3.0 mg/dL. * Myocardial infarction in 72 hours proceeding the stenting procedure (if possible, postponing the procedure) * Pregnancy (positive pregnancy test) * Coagulopathy. * History of uncontrolled contrast media intolerance Angiographic Inclusion Criteria: * De novo lesion in major arteries or grafts connecting arteries * Stenosis eligible for endovascular treatment per Vascular Team evaluation (according to current standards and guidelines) * High risk morphology stenosis (per 2 independent, experienced operators)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of procedural success | Up to 48 hours after procedure or until hospital discharge, whichever came first. | Procedural success, defined as technical success (successful delivery and implantation of the stent) AND residual stenosis ≤ 30% of vessel lumen diameter AND clinical success (no peri-procedural complications) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vessel patency in CT angiography at 6 months | At 6 months after procedure | Vessel patency in CT angiography (if not contraindicated) at 6 months |
| Number of In-hospital MACNE (Major Adverse Cardiovascular or Neurological Events) | Up to 48 hours after procedure or until hospital discharge, whichever came first. | In-hospital MACNE (death, stroke, myocardial infarction, acute limb or target organ ischemia) |
| Number of MACNE at 30 days | At 30 days after procedure | MACNE at 30 days (death, stroke, myocardial infarction, acute limb or target organ ischemia) |
| Duplex Ultrasound Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) in target vessel at 12 months | At 12 months after procedure | Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) on ultrasound evaluation of the stented segment (if accessible) |
| Rate of peri-procedural complications | Up to 48 hours after procedure | Any peri-procedural complications until 48 hrs |
| Duplex Ultrasound Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) in the stented segment at discharge | 24 hours after procedure | Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) on ultrasound evaluation of the stented segment (if accessible) |
| Duplex Ultrasound Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) in the stented segment at 6 months | At 6 months after procedure | Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) on ultrasound evaluation of the stented segment (if accessible) |
| Number of MACNE at 6 months | At 6 months after procedure | MACNE at 6 months (death, stroke, myocardial infarction, acute limb or target organ ischemia) |
Countries
Poland
Contacts
Primary ContactPiotr Musialek, MD, DPhil
Outcome results
None listed