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

Peripheral Vascular Diseases Clinical Trial

— FLOW-Guard  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04461717
• Other study ID #: FLOW-Guard
• Status: Recruiting
• Start date: February 27, 2020
• Est. completion date: February 28, 2021

Study information

• Verified date: August 2020
• Source: John Paul II Hospital, Krakow
• Contact: Piotr Musialek, MD, DPhil
• Phone: +48126142287
• Email: p.musialek[@]szpitaljp2.krakow.pl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 28, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

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

Locations

Country	Name	City	State
Poland	Department of Cardiac and Vascular Diseases, The John Paul II Hospital	Kraków	Maloplska

Sponsors (1)

Lead Sponsor	Collaborator
John Paul II Hospital, Krakow

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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
Secondary	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
Secondary	Rate of peri-procedural complications	Any peri-procedural complications until 48 hrs	Up to 48 hours after procedure
Secondary	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
Secondary	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
Secondary	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
Secondary	Vessel patency in CT angiography at 6 months	Vessel patency in CT angiography (if not contraindicated) at 6 months	At 6 months after procedure