Peripheral Vascular DiseasesFLOW-GuardNCT04461717
Micronet Covered Stent in in Arterial Locations Beyond the Carotid Bifurcation - FLOW-Guard Study
An observational study of Peripheral Vascular Diseases, run by John Paul II Hospital, Krakow at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Vascular Diseases
- What is being tested?
- MicroNet covered stent implantation in the increased risk arterial lesions beyond the carotid bifurcation
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- 27 Feb 2020to 28 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with peripheral artery stenosis evaluated by Vascular Team with endovascular treatment recommendation and high risk morphology plaque
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Department of Cardiac and Vascular Diseases, The John Paul II Hospital
Krakow, Maloplska, 31-202
Piotr Musialek, Prof, +48126142287, p.musialek@szpitaljp2.krakow.pl
About this 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
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.
Read the 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
- Being tested
- MicroNet covered stent implantation in the increased risk arterial lesions beyond the carotid bifurcation
- Medical subject headings
- Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicroNet covered stent implantation in the increased risk arterial lesions beyond the carotid bifurcationDevice
Implantation of the MicroNet covered stent in the increased risk arterial lesions beyond the carotid bifurcation as per Vascular Team recommendation
| Study group | Role | What they receive |
|---|---|---|
| MicroNet covered stenting (interventional) | MicroNet covered stent implantation for increased risk arterial lesions beyond the carotid bifurcation Receives: Device: MicroNet covered stent implantation in the increased risk arterial lesions beyond the carotid bifurcation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Up to 48 hours after procedure or until hospital discharge, whichever came first.
Secondary outcomes (8)
Number of In-hospital MACNE (Major Adverse Cardiovascular or Neurological Events)
In-hospital MACNE (death, stroke, myocardial infarction, acute limb or target organ ischemia)
Measured: 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)
Measured: 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)
Measured: At 6 months after procedure
Rate of peri-procedural complications
Any peri-procedural complications until 48 hrs
Measured: 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)
Measured: 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)
Measured: 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)
Measured: At 12 months after procedure
Vessel patency in CT angiography at 6 months
Vessel patency in CT angiography (if not contraindicated) at 6 months
Measured: At 6 months after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start27 Feb 2020
- Primary completion28 Feb 2021 (estimated)
- Study completion28 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Vascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- John Paul II Hospital, Krakow
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Piotr Musialek, MD, DPhil, Principal investigator, John Paul II Hospital, Krakow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04461717
- Sponsor's protocol ID
- FLOW-Guard
- Acronym
- FLOW-Guard
- Status last verified
- Aug 2020
- First submitted
- 8 Jun 2020
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04461717
- Acronym / sponsor ID
- FLOW-Guard / FLOW-Guard
- Conditions
- Peripheral Vascular Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- John Paul II Hospital, KrakowUniversity, hospital or other
- Study start
- 27 Feb 2020 (actual)
- Primary completion
- 28 Feb 2021 (estimated)
- Study completion
- 28 Feb 2021 (estimated)
- First posted
- 8 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MicroNet covered stenting (interventional) | – | Device: MicroNet covered stent implantation in the increased risk arterial lesions beyond the carotid bifurcationMicroNet covered stent implantation for increased risk arterial lesions beyond the carotid bifurcation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with peripheral artery stenosis evaluated by Vascular Team with endovascular treatment recommendation and high risk morphology plaque
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MicroNet covered stent implantation in the increased risk arterial lesions beyond the carotid bifurcationImplantation of the MicroNet covered stent in the increased risk arterial lesions beyond the carotid bifurcation as per Vascular Team recommendation | Device | MicroNet covered stenting (interventional) |
Primary outcome
Rate of procedural success
Time frame: 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)
8 secondary outcomes
Number of In-hospital MACNE (Major Adverse Cardiovascular or Neurological Events)
Time frame: Up to 48 hours after procedure or until hospital discharge, whichever came first.
Number of MACNE at 30 days
Time frame: At 30 days after procedure
Number of MACNE at 6 months
Time frame: At 6 months after procedure
Rate of peri-procedural complications
Time frame: Up to 48 hours after procedure
Duplex Ultrasound Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) in the stented segment at discharge
Time frame: 24 hours after procedure
Duplex Ultrasound Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) in the stented segment at 6 months
Time frame: At 6 months after procedure
Duplex Ultrasound Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) in target vessel at 12 months
Time frame: At 12 months after procedure
Vessel patency in CT angiography at 6 months
Time frame: At 6 months after procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Piotr Musialek, MD, DPhil principal investigator
John Paul II Hospital, Krakow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Vascular Diseases, run by John Paul II Hospital, Krakow at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Piotr Musialek, MD, DPhil (+48126142287, p.musialek@szpitaljp2.krakow.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of procedural success (time frame: Up to 48 hours after procedure or until hospital discharge, whichever came first.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2020.