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

NCT04461717 | Unknown

• 1 other identifier: FLOW-Guard
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Vascular Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Number of In-hospital MACNE (Major Adverse Cardiovascular or Neurological Events)

  Up to 48 hours after procedure or until hospital discharge, whichever came first.

• Number of MACNE at 30 days

  At 30 days after procedure

• Number of MACNE at 6 months

  At 6 months after procedure

• Rate of peri-procedural complications

  Up to 48 hours after procedure

• Duplex Ultrasound Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) in the stented segment at discharge

  24 hours after procedure

Study Arms (1)

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

Interventions

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

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

MicroNet covered stenting (interventional)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)
• 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

Sponsors & Collaborators

• John Paul II Hospital, Krakow: lead

Study Sites (1)

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

Krakow, Maloplska, 31-202, Poland

RECRUITING

MeSH Terms

Conditions

Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Piotr Musialek, MD, DPhil

  John Paul II Hospital, Krakow

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Piotr Musialek, MD, DPhil

CONTACT

+48126142287; p.musialek@szpitaljp2.krakow.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2020
• First Posted: July 8, 2020
• Study Start: February 27, 2020
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: September 2, 2020

Record last verified: 2020-08

Locations

PL (1)