← Back to Search

Device

AngioSafe Peripheral CTO Crossing System for Peripheral Arterial Disease (RESTOR-1 Trial)

N/A

Recruiting

Led By Subhash Banerjee, MD

Research Sponsored by AngioSafe, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up procedure

Awards & highlights

RESTOR-1 Trial Summary

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

Eligible Conditions

Peripheral Arterial Disease
Peripheral Artery Disease

RESTOR-1 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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.

Secondary outcome measures

Evaluation of intraluminal CTO crossing facilitated by the Peripheral CTO Crossing System, as assessed by an Intravascular Ultrasound (IVUS).

Procedural Success of AngioSafe Peripheral CTO Crossing System

Technical Success of AngioSafe Peripheral CTO Crossing System

+1 more

RESTOR-1 Trial Design

1Treatment groups

Experimental Treatment

Group I: AngioSafe Peripheral CTO Crossing System ProcedureExperimental Treatment1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

AngioSafe, Inc.Lead Sponsor

Veranex, Inc.UNKNOWN

Subhash Banerjee, MDPrincipal InvestigatorNorth Texas Veterans Healthcare System

18 Previous Clinical Trials

4,018,411 Total Patients Enrolled

4 Trials studying Peripheral Arterial Disease

14,253 Patients Enrolled for Peripheral Arterial Disease

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

AngioSafe Peripheral CTO Crossing System Study (RESTOR-1 Study)

2021. "AngioSafe Peripheral CTO Crossing System Study (RESTOR-1 Study)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04663867.