Micronet Covered Stent in in Arterial Locations Beyond the Carotid Bifurcation - FLOW-Guard Study

• Conditions: Peripheral Vascular Diseases
• Interventions: Device: MicroNet covered stent implantation in the increased risk arterial lesions beyond the carotid bifurcation

• Registration Number: NCT04461717
• Lead Sponsor: John Paul II Hospital, Krakow

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.

Study Timeline

• Study Start: 2020-02-27
• Study First Submitted: 2020-06-08
• Study First Submitted QC: 2020-07-02
• Study First Posted: 2020-07-08
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-31
• Last Update Posted: 2020-09-02
• Primary Completion: 2021-02-28
• Study Completion: 2021-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
MicroNet covered stenting (interventional)	MicroNet covered stent implantation in the increased risk arterial lesions beyond the carotid bifurcation	MicroNet covered stent implantation for increased risk arterial lesions beyond the carotid bifurcation

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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)
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 6 months	At 6 months after procedure	MACNE at 6 months (death, stroke, myocardial infarction, acute limb or target organ ischemia)
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 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)
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)

Trial Locations

Locations (1)

Department of Cardiac and Vascular Diseases, The John Paul II Hospital; 🇵🇱 Kraków, Maloplska, Poland