Actively Recruiting
A Prospective, Multicenter, Single Arm, Real-World Registry Assessing the Clinical Use 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
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of the Rotarex(TM) Rotational Excisional Atherectomy System in people treated for Peripheral Arterial Disease (PAD). This prospective, single-arm, multicenter registry study aims to observe real-world clinical outcomes of this device in treating lesions in infra-inguinal peripheral arteries. Approximately 600 subjects will be recruited to better understand the device's procedural success and safety profile. Participants will receive treatment using the Rotarex(TM) Rotational Excisional Atherectomy System according to the device's instructions for use. The study includes patients with specific stages of chronic and acute limb ischemia (Rutherford classifications 2-5 for chronic and I to IIb for acute). The target lesion must be accessible by guidewire and suitable for treatment with this device. The study is single-arm, meaning all enrolled participants will receive this intervention without comparison to other treatments. During the study, participants will be monitored for procedural success immediately after treatment and followed for 30 days post-procedure to assess freedom from major complications. Subjects must comply with follow-up visits and procedures as part of the study. Researchers will collect data on the treatment outcomes and safety to evaluate the real-world use of the Rotarex(TM) device. The total duration of participation varies depending on individual follow-up requirements.
CONDITIONS
Brief 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 using an approved form.
- Subject is 22 years old or older at the time of signing consent.
- Lesion(s) in infra-inguinal peripheral arteries suitable for treatment with Rotarex(TM) device.
- Rutherford classification 2-5 for chronic limb ischemia or I to IIb for acute limb ischemia.
- Target lesion can be crossed intra-luminally by guidewire.
- At least one patent native outflow artery to the foot free from significant stenosis (≥50%) (for chronic limb ischemia only).
You will not qualify if you...
- Unable or unwilling to comply with follow-up procedures and visits.
- Target lesion in a vessel smaller than 3 mm in diameter.
- Participating in another device or drug clinical trial that interferes with this study.
- Treatment plan includes use of thrombectomy or atherectomy devices other than Rotarex(TM).
- Life expectancy less than 1 year.
- Pregnant, planning pregnancy during the study, or nursing a child.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Immediate post index procedure
Participants receive treatment with the Rotarex(TM) Rotational Excisional Atherectomy System to address lesions in peripheral arteries.
1 treatment visit (in-person)
Duration - 30 days post index procedure
Participants are monitored for complications and clinical outcomes following treatment.
1 follow-up visit (in-person)
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
T
Talar Saber
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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