Real-World Registry of the Rotarex(TM) Rotational Excisional Atherectomy System (XTRACT Registry)

Part of paid clinical trials in Lakeland, Florida.

Sponsor
C. R. Bard
Study ID
NCT07016698
Status
Recruiting
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Conditions

  • Peripheral Arterial Disease(PAD)

Eligibility Criteria

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

Interventions

  • Rotarex(TM) Rotational Excisional Atherectomy System — DEVICE
    Subjects treated with Rotarex(TM) Rotational Excisional Atherectomy System

Study Details

The XTRACT Registry is a prospective, single arm multicenter study on the use of on the Rotarex(TM) Rotational Excisional Atherectomy System.

Key Dates

Start date
Sep 29, 2025
Status verified
Dec 2025
Primary completion
Mar 31, 2029
Completion
May 31, 2029

Study Design

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

Arms

  • Other: Rotarex(TM) Rotational Excisional Atherectomy System
    Subjects treated with RotarexTM Rotational Excisional Atherectomy System

Primary Outcome Measure

Procedural Success [ Time Frame: Immediate Post Index Procedure ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Radiology and Imaging SpecialistsLakelandFlorida33805
Adrija Sharma
[email protected]
901-457-8360
Vital Heart and VeinHumbleTexas77338
Adrija Sharma
[email protected]
901-457-8360

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By research site
Radiology and Imaging Specialists· Lakeland, FLVital Heart and Vein· Humble, TX

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