The Golazo® Peripheral Atherectomy System for a Safe and Effective Atherectomy (GREAT Trial)

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Avantec Vascular
Study ID
NCT06321575
Status
Recruiting
Apply to this trial

Conditions

  • Peripheral Arterial Disease

Eligibility Criteria

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

Interventions

  • Golazo® Peripheral Atherectomy System (Golazo® Peripheral AS) — DEVICE
    Golazo® Peripheral AS is a sterile, single-use percutaneous device that has two main components: 1) the Golazo® Accustrike atherectomy catheter, and 2) the Golazo® motorized drive unit (MDU) and is intended for use in atherectomy of the peripheral vasculature.

Study Details

The objective of this study is to establish reasonable assurance of safety and effectiveness of the Golazo® Peripheral Atherectomy System when used as indicated in 159 subjects with symptomatic infrainguinal peripheral arterial disease (PAD) in up to 20 investigational sites in the U.S.

Key Dates

Start date
Jun 20, 2024
Status verified
Jun 2026
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

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

Arms

  • Experimental: Golazo® Peripheral Atherectomy System
    Treatment atherectomy of the peripheral vasculature with the Golazo® Peripheral Atherectomy System.

Primary Outcome Measure

Freedom from major adverse events (MAE) [ Time Frame: Index procedure through 30-day follow-up ]

Central Contacts

Locations (20)

FacilityCityStateZIPSite coordinators
HonorHealth Scottsdale Osborn Medical CenterScottsdaleArizona85251-
Pulse Cardiovascular InstituteScottsdaleArizona85251
Anita Ramaiah, MD
480-600-0600
Venkatesh Ramaiah, MD (PRINCIPAL_INVESTIGATOR)
Merced VascularMercedCalifornia95340
Mani Nallasivan, MD (PRINCIPAL_INVESTIGATOR)
Palm Vascular CenterFort LauderdaleFlorida33312
Jennifer Gimeno
[email protected]
Robert Beasley, MD (PRINCIPAL_INVESTIGATOR)
First Coast Cardiovascular InstituteJacksonvilleFlorida32256
Amy Suphachinda
[email protected]
904-493-3333
Vaqar Ali, MD (PRINCIPAL_INVESTIGATOR)
Yazan Khatib, MD (SUB_INVESTIGATOR)
Radiology and Imaging Specialists of LakelandLakelandFlorida33801-
Amavita Research ServicesMiamiFlorida33137
Nereisy Alonso
[email protected]
786-537-4559
Yasnaya Cruz-Santiago
[email protected]
Pedro Martinez-Clark, MD (PRINCIPAL_INVESTIGATOR)
Cardiovascular Consultants of South GeorgiaThomasvilleGeorgia31792
Lenore Beckett, RN
[email protected]
Lauren Montgomery
229-584-5575
B. Clay Sizemore, MD (PRINCIPAL_INVESTIGATOR)
Pacific Vascular Institute‘AieaHawaii96701
Amber Parrilla
[email protected]
808-784-3050
Joann Kalna
[email protected]
808-784-3050
Amr El-Sergany, MD (PRINCIPAL_INVESTIGATOR)
Baton Rouge General HospitalBaton RougeLouisiana70809
Jamie Mooney
225-237-1673
Mary Hamilton
225-237-1673
Joseph Griffin, MD (PRINCIPAL_INVESTIGATOR)
Cardiovascular Institute of the South - HoumaHoumaLouisiana70360
Deanna Benoit
[email protected]
Darla Patrick
[email protected]
Matthew Finn, MD (PRINCIPAL_INVESTIGATOR)
Cardiovascular Institute of the South - LafayetteLafayetteLouisiana70506
Nichol Charles
[email protected]
337-289-8429
Ariel Quebedeaux
[email protected]
337-289-8429
Amit Amin, MD (PRINCIPAL_INVESTIGATOR)
Vascular BreakthroughsPlymouthMassachusetts02360
Elizabeth Gagne
203-548-7860
Maria Myslinski
203-548-7860
Scott James, DO (PRINCIPAL_INVESTIGATOR)
Advanced Heart and Vascular InstituteFlemingtonNew Jersey08822
Alexis Bellafiore
908-237-3405
Erin Squindo
908-237-3405
Andrey Espinoza, MD (PRINCIPAL_INVESTIGATOR)
Spartanburg Regional Medical CenterSpartanburgSouth Carolina29303
Darla Howard, RN
[email protected]
864-560-1042
Shannon Stancil
[email protected]
864-560-1036
Brian Brown, MD (PRINCIPAL_INVESTIGATOR)
Tennessee Center for Clinical TrialsTullahomaTennessee37388
Dinesh Gupta, MD (PRINCIPAL_INVESTIGATOR)
Nextstage Clinical Research - BeaumontBeaumontTexas77702
Jorge Hernandez, MD (PRINCIPAL_INVESTIGATOR)
Hope Vascular & PodiatryHoustonTexas77054
Miguel Montero-Backer
[email protected]
Stuart Baugher
[email protected]
(346) 541-6421
Miguel Montero-Baker, MD (PRINCIPAL_INVESTIGATOR)
Nextstage Clinical Research - WacoWacoTexas76712
Donald S Cross, MD (PRINCIPAL_INVESTIGATOR)
Bellin HealthGreen BayWisconsin54301
Katherine Guilliams
920-617-2060
Christen Piaskowski
920-617-2060
Jason Ricci, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Scottsdale, AZ

By research site
HonorHealth Scottsdale Osborn Medical Center· Scottsdale, AZPulse Cardiovascular Institute· Scottsdale, AZMerced Vascular· Merced, CAPalm Vascular Center· Fort Lauderdale, FLFirst Coast Cardiovascular Institute· Jacksonville, FLRadiology and Imaging Specialists of Lakeland· Lakeland, FL

Related Studies