Auryon Atherectomy System With Standard Balloon Angioplasty Versus Standard Balloon Angioplasty Alone

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Angiodynamics, Inc.
Study ID
NCT06777901
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Peripheral Arterial Diseases

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Auryon Atherectomy System — DEVICE
    Auryon Atherectomy System is composed of a laser and catheter
  • Balloon Angioplasty — DEVICE
    Balloon Angioplasty alone

Study Details

The goal of this clinical trial is to learn if the Auryon Atherectomy System with balloon angioplasty safe and effective in treating lower limb blockages. The main question it aims to answer is: Is treatment with Auryon Atherectomy System more effective than angioplasty alone in preventing death, amputation, revascularization and improving patency? Researchers will compare the Auryon Atherectomy System with balloon angioplasty to balloon angioplasty alone.

Key Dates

Start date
Apr 21, 2025
Status verified
May 2025
Primary completion
Feb 28, 2029
Completion
Apr 30, 2029

Study Design

Enrollment
224 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Auryon Atherectomy System and Balloon Angioplasty
    Subjects will be treated with the Auryon Atherectomy System followed by Percutaneous Balloon Angioplasty
  • Active Comparator: Balloon Angioplasty Only
    Subjects assigned to this treatment group will be treated with percutaneous balloon angioplasty only.

Primary Outcome Measure

Win-ratio comparing subjects in the treatment group versus the control group on the components of the composite endpoints in a hierarchical fashion at 12 months [ Time Frame: From enrollment to the end of treatment at 12 months ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
Abrazo Arizona Heart HospitalPhoenixArizona85204
Ryleigh Alfonso
[email protected]
480-433-7311
Stephen Smith, MD (PRINCIPAL_INVESTIGATOR)
Kaiser PermanenteSan DiegoCalifornia92123
Michael Fechter
[email protected]
858-266-6604
Michael Girard, MD (PRINCIPAL_INVESTIGATOR)
CIS Grey ASCGrayLouisiana70359
Deanna Benoit
[email protected]
(985) 873-5613
Craig Walker, M.D (PRINCIPAL_INVESTIGATOR)
MedStar Health Research InstituteBaltimoreMaryland21218
Keith Moyer
[email protected]
443-278-9170
Jason Crowner, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114
Jaimie Atwood
[email protected]
617-726-2264
Anahita Dua, MD (PRINCIPAL_INVESTIGATOR)
The Washington UniversitySt LouisMissouri63110
Isabella Mineiro
[email protected]
Carlos Guevara, MD (PRINCIPAL_INVESTIGATOR)
University of North Carolina Chapel HillChapel HillNorth Carolina27599
University Hospitals Cleveland Medical CenterClevelandOhio44106
Christopher Ernst
[email protected]
216-844-7637
Jun Li, MD (PRINCIPAL_INVESTIGATOR)
Prisma Heath-University Medical GroupGreenvilleSouth Carolina29601
Maggie Salle
[email protected]
864-607-3405
Sagar Gandhi, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Phoenix, AZ

By research site
Abrazo Arizona Heart Hospital· Phoenix, AZKaiser Permanente· San Diego, CACIS Grey ASC· Gray, LAMedStar Health Research Institute· Baltimore, MDMassachusetts General Hospital· Boston, MAThe Washington University· St Louis, MO

Related Studies