Actively Recruiting
Real-World Registry of the Rotarex(TM) Rotational Excisional Atherectomy System (XTRACT Registry)
Led by C. R. Bard · Updated on 2025-12-17
600
Participants Needed
2
Research Sites
191 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The XTRACT Registry is a prospective, single arm multicenter study on the use of on the Rotarex(TM) Rotational Excisional Atherectomy System.
CONDITIONS
Official Title
Real-World Registry of the Rotarex(TM) Rotational Excisional Atherectomy System (XTRACT Registry)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject or legally authorized representative provides written informed consent.
- Subject is 22 years or older at time of consent.
- Subject has lesion(s) in infra-inguinal peripheral arteries suitable for treatment with the Rotarex device per its Instructions For Use.
- Subjects with chronic limb ischemia classified as Rutherford 2 to 5.
- Subjects with acute limb ischemia classified as Rutherford I to IIb.
- Target lesion can be crossed intra-luminally by guidewire.
- For chronic limb ischemia group only: at least one patent native outflow artery to the foot without significant stenosis (≤50% narrowing).
You will not qualify if you...
- Subject is unable or unwilling to comply with follow-up procedures and visits.
- Target lesion is in a vessel smaller than 3 mm in diameter.
- Subject is participating in another clinical trial that interferes with this study.
- Planned treatment includes use of thrombectomy or atherectomy devices other than the Rotarex system.
- Life expectancy is less than 1 year.
- Subject is pregnant, planning to become pregnant during the study, or nursing a child.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Radiology and Imaging Specialists
Lakeland, Florida, United States, 33805
Actively Recruiting
2
Vital Heart and Vein
Humble, Texas, United States, 77338
Actively Recruiting
Research Team
A
Adrija Sharma, PhD
CONTACT
T
Talar Saber
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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