AngioSafe Peripheral CTO Crossing System for Peripheral Artery Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Mercy Hospital South, Saint Louis, MOPeripheral Artery Disease+1 MoreAngioSafe Peripheral CTO Crossing System - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test a new device to see if it is safe and effective at treating blocked arteries.

Eligible Conditions
  • Peripheral Artery Disease
  • Peripheral Arterial Disease

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Misago® RX Self-expanding Peripheral Stent
2
CUSA-081
1
SELUTION SLR™ 018 DEB

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 30 Days

24 Hours
Clinical Success is defined as Technical Success in the absence of device-related major adverse events through discharge or 24-hours post-procedure, whichever is sooner.
30 Days
Procedural Success of AngioSafe Peripheral CTO Crossing System
Procedure
Evaluation of intraluminal CTO crossing facilitated by the Peripheral CTO Crossing System, as assessed by an Intravascular Ultrasound (IVUS).
Technical Success of AngioSafe Peripheral CTO Crossing System
The primary endpoint in the subgroup of the degree of calcification (none/focal/mild/moderate, severe).

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Misago® RX Self-expanding Peripheral Stent
3
CUSA-081
1
SELUTION SLR™ 018 DEB

Trial Design

1 Treatment Group

AngioSafe Peripheral CTO Crossing System Procedure
1 of 1

Experimental Treatment

100 Total Participants · 1 Treatment Group

Primary Treatment: AngioSafe Peripheral CTO Crossing System · No Placebo Group · N/A

AngioSafe Peripheral CTO Crossing System Procedure
Device
Experimental Group · 1 Intervention: AngioSafe Peripheral CTO Crossing System · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 30 days

Who is running the clinical trial?

Veranex, Inc.UNKNOWN
AngioSafe, Inc.Lead Sponsor
Subhash Banerjee, MDPrincipal InvestigatorNorth Texas Veterans Healthcare System
18 Previous Clinical Trials
4,018,411 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

Is there availability to join this experiment?

"That is correct. According to the data on clinicaltrials.gov, this research study has been actively searching for patients since February 1st 2021 and most recently modified on November 22nd 2022. As of now, 100 individuals are needed from 18 locations." - Anonymous Online Contributor

Unverified Answer

To what extent is the current research involving individuals receiving treatment?

"Affirmative. Clinicaltrials.gov confirms that this clinical investigation, which was first published on February 1st 2021, is actively recruiting patients for enrolment. The project requires 100 individuals to be enrolled at 18 different research sites." - Anonymous Online Contributor

Unverified Answer

Can you enumerate the sites where this medical trial is being conducted?

"This clinical trial is being administered through Dignity Health - Chandler Regional Medical Center in Arizona, Vascular Care Group in Massachusetts, and Coastal Vascular & Interventional, PLLC in Florida. Additionally there are 18 other sites hosting this research project." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top