FastWire REvascularisation of Extremities, (For LOWer Limbs) - FREEFLOW

Part of paid clinical trials in Wilmington, Delaware.

Sponsor
Versono Medical Ltd
Study ID
NCT06492733
Status
Recruiting
Apply to this trial

Conditions

  • Chronic Total Occlusion of Artery of the Extremities

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • FastWire System - Peripheral — DEVICE
    The Investigator can use the FastWire System during the procedure to cross CTO Caps and/or to cross multiple lesions.

Study Details

This study is to assess the safety and efficacy of the FastWire System. It is intended to assess that the FastWire System can facilitate the intra-luminal placement of conventional guidewires or treatment devices beyond peripheral artery chronic total occlusions (CTOs)

Key Dates

Start date
Nov 5, 2024
Status verified
Dec 2025
Primary completion
May 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
65 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: FastWire System - Peripheral
    This study is to assess the safety and efficacy of the FastWire System. It is intended to assess that the FastWire System can facilitate the intra-luminal placement of conventional guidewires or treatment devices beyond peripheral artery chronic total occlusions (CTOs).

Primary Outcome Measure

Clinical success (On Day of Procedure) [ Time Frame: Day 1 ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
EndoVascular ConsultantsWilmingtonDelaware19805
Jas Kaur
[email protected]
347-944-4694
Dr. Mark Garcia, MD (PRINCIPAL_INVESTIGATOR)
Vascular & Embolization SpecialistsCocoaFlorida32926
Brandon Galaviz
[email protected]
210-990-5556
Dr Derek Mittleider, MD (PRINCIPAL_INVESTIGATOR)
Vascular Institute of the MidwestDavenportIowa52807
Dr. Eric Dippel, M.D.
[email protected]
563-324-3818
Dr. Eric Dippel, M.D. (PRINCIPAL_INVESTIGATOR)
Cardiovascular Institute of the South-ASCGrayLouisiana70359
Darla Patrick, RN, CCRC
[email protected]
985-873-5684
Dr. Craig Walker, M.D. (PRINCIPAL_INVESTIGATOR)
Dearborn CardiologyDearbornMichigan48126
Sam Rengade
[email protected]
313-887-4011
Dr Fadi Saab, MD (PRINCIPAL_INVESTIGATOR)
Vascular Institute of ChattanoogaChattanoogaTennessee37421
Lacey Weeks
[email protected]
423-602-2750
Dr. Christopher LeSar, M.D. (PRINCIPAL_INVESTIGATOR)

Find similar trials in Wilmington, DE

By research site
EndoVascular Consultants· Wilmington, DEVascular & Embolization Specialists· Cocoa, FLVascular Institute of the Midwest· Davenport, IACardiovascular Institute of the South-ASC· Gray, LADearborn Cardiology· Dearborn, MIVascular Institute of Chattanooga· Chattanooga, TN

Related Studies