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

NCT ID: NCT04461717

Last Updated: 2020-09-02

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-02-27
• Study Completion Date: 2021-02-28

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.

Conditions

Peripheral Vascular Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

MicroNet covered stenting (interventional)

MicroNet covered stent implantation for increased risk arterial lesions beyond the carotid bifurcation

MicroNet covered stent implantation in the increased risk arterial lesions beyond the carotid bifurcation

Intervention Type: DEVICE

Implantation of the MicroNet covered stent in the increased risk arterial lesions beyond the carotid bifurcation as per Vascular Team recommendation

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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

• 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

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

John Paul II Hospital, Krakow

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Piotr Musialek, MD, DPhil

Role: PRINCIPAL_INVESTIGATOR

John Paul II Hospital, Krakow

Locations

Department of Cardiac and Vascular Diseases, The John Paul II Hospital

Krakow, Maloplska, Poland

Site Status: RECRUITING

Countries

Poland

Central Contacts

Piotr Musialek, MD, DPhil

Role: CONTACT

p.musialek@szpitaljp2.krakow.pl

+48126142287

Facility Contacts

Piotr Musialek, Prof

Role: primary

p.musialek@szpitaljp2.krakow.pl

+48126142287

Other Identifiers

FLOW-Guard

Identifier Type: -

Identifier Source: org_study_id