An observational study in Peripheral Vascular Diseases, sponsored by John Paul II Hospital, Krakow. Status unknown at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-02.
Sponsored by John Paul II Hospital, Krakow · Observational
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.
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.
1,027 studies on the registry are indexed under Vascular Diseases; 167 are open to participants now.
This study's planned enrollment of 50 is below the median of 200 across 301 observational studies indexed under Vascular Diseases.
Browse Vascular Diseases studies →John Paul II Hospital, Krakow is the lead sponsor of 15 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with peripheral artery stenosis evaluated by Vascular Team with endovascular treatment recommendation and high risk morphology plaque
General
Inclusion Criteria:
Exclusion Criteria:
Angiographic
Inclusion Criteria:
Exclusion Criteria:
MicroNet covered stent implantation for increased risk arterial lesions beyond the carotid bifurcation
Device: MicroNet 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
Rate of procedural success
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)
Time frame: Up to 48 hours after procedure or until hospital discharge, whichever came first.
Number of In-hospital MACNE (Major Adverse Cardiovascular or Neurological Events)
In-hospital MACNE (death, stroke, myocardial infarction, acute limb or target organ ischemia)
Time frame: Up to 48 hours after procedure or until hospital discharge, whichever came first.
Number of MACNE at 30 days
MACNE at 30 days (death, stroke, myocardial infarction, acute limb or target organ ischemia)
Time frame: At 30 days after procedure
Number of MACNE at 6 months
MACNE at 6 months (death, stroke, myocardial infarction, acute limb or target organ ischemia)
Time frame: At 6 months after procedure
Rate of peri-procedural complications
Any peri-procedural complications until 48 hrs
Time frame: Up to 48 hours after procedure
Duplex Ultrasound Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) in the stented segment at discharge
Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) on ultrasound evaluation of the stented segment (if accessible)
Time frame: 24 hours after procedure
Duplex Ultrasound Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) in the stented segment at 6 months
Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) on ultrasound evaluation of the stented segment (if accessible)
Time frame: At 6 months after procedure
Duplex Ultrasound Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) in target vessel at 12 months
Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) on ultrasound evaluation of the stented segment (if accessible)
Time frame: At 12 months after procedure
Vessel patency in CT angiography at 6 months
Vessel patency in CT angiography (if not contraindicated) at 6 months
Time frame: At 6 months after procedure
This study is status unknown, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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John Paul II Hospital, Krakow