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

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

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.

Study Overview

• Status: Unknown
• Conditions: Peripheral Vascular Diseases
• Intervention / Treatment: Device: MicroNet covered stent implantation in the increased risk arterial lesions beyond the carotid bifurcation

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 Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• Poland
  • Maloplska
    • Kraków, Maloplska, Poland, 31-202
      • Recruiting
      • Department of Cardiac and Vascular Diseases, The John Paul II Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MicroNet covered stenting (interventional); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Up to 48 hours after procedure or until hospital discharge, whichever came first.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of In-hospital MACNE (Major Adverse Cardiovascular or Neurological Events)	In-hospital MACNE (death, stroke, myocardial infarction, acute limb or target organ ischemia)	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)	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)	At 6 months after procedure
Rate of peri-procedural complications	Any peri-procedural complications until 48 hrs	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)	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)	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)	At 12 months after procedure
Vessel patency in CT angiography at 6 months	Vessel patency in CT angiography (if not contraindicated) at 6 months	At 6 months after procedure

Collaborators and Investigators

• Sponsor: John Paul II Hospital, Krakow
• Investigators: Principal Investigator: Piotr Musialek, MD, DPhil, John Paul II Hospital, Krakow

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2020
• Primary Completion (Anticipated): February 28, 2021
• Study Completion (Anticipated): February 28, 2021

Study Registration Dates

• First Submitted: June 8, 2020
• First Submitted That Met QC Criteria: July 2, 2020
• First Posted (Actual): July 8, 2020

Study Record Updates

• Last Update Posted (Actual): September 2, 2020
• Last Update Submitted That Met QC Criteria: August 31, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: FLOW-Guard

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No