Clinical trial NCT04461717: Micronet Covered Stent in in Arterial Locations Beyond the Carotid Bifurcation - FLOW-Guard Study
Official title: Prospective Observational Study of Procedures With MicroNet Covered Stent Use to Treat Increased Risk Lesions in Arterial Locations Beyond the Carotid Bifurcation - FLOW-Guard Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peripheral Vascular Diseases
Lead sponsor: John Paul II Hospital, Krakow
Sponsor class: OTHER
First posted: 2020-07-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with peripheral artery stenosis evaluated by Vascular Team with endovascular treatment recommendation and high risk morphology plaque

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.

Eligibility 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)

Exclusion Criteria:

* 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 target lesion

Primary outcomes:
measure: Rate of procedural success
timeFrame: Up to 48 hours after procedure or until hospital discharge, whichever came first.
Secondary outcomes:
measure: Number of In-hospital MACNE (Major Adverse Cardiovascular or Neurological Events)
timeFrame: Up to 48 hours after procedure or until hospital discharge, whichever came first.
measure: Number of MACNE at 30 days
timeFrame: At 30 days after procedure
measure: Number of MACNE at 6 months
timeFrame: At 6 months after procedure
measure: Rate of peri-procedural complications
timeFrame: Up to 48 hours after procedure
measure: Duplex Ultrasound Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) in the stented segment at discharge
timeFrame: 24 hours after procedure
measure: Duplex Ultrasound Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) in the stented segment at 6 months
timeFrame: At 6 months after procedure
measure: Duplex Ultrasound Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) in target vessel at 12 months
timeFrame: At 12 months after procedure
measure: Vessel patency in CT angiography at 6 months
timeFrame: At 6 months after procedure
Other outcomes:
Locations:
city: Kraków
country: Poland
facility: Department of Cardiac and Vascular Diseases, The John Paul II Hospital
state: Maloplska
Study officials:
affiliation: John Paul II Hospital, Krakow
name: Piotr Musialek, MD, DPhil
role: PRINCIPAL_INVESTIGATOR
References: