Real-World Registry of the Rotarex(TM) Rotational Excisional Atherectomy System (XTRACT Registry)
NCT ID: NCT07016698
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
600 participants
INTERVENTIONAL
2025-09-29
2029-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Rotarex(TM) Rotational Excisional Atherectomy System
Subjects treated with RotarexTM Rotational Excisional Atherectomy System
Rotarex(TM) Rotational Excisional Atherectomy System
Subjects treated with Rotarex(TM) Rotational Excisional Atherectomy System
Interventions
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Rotarex(TM) Rotational Excisional Atherectomy System
Subjects treated with Rotarex(TM) Rotational Excisional Atherectomy System
Eligibility Criteria
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Inclusion Criteria
2. Subject is ≥22 years old at the time of signing the informed consent.
3. Subject must have a lesion(s) in their infra-inguinal peripheral arteries that can be treated with the RotarexTM Rotational Excisional Atherectomy System according to Instructions For Use (IFU).
4. Rutherford 2-5 for chronic limb ischemia and Rutherford I to IIb for acute limb ischemia.
5. Target lesion can be crossed intra-luminally by guidewire.
6. At least one patent native outflow artery to the foot, free from significant stenosis(≥50% stenosis as confirmed by angiography) (ChLI Cohort only, not applicable to ALI Cohort).
Exclusion Criteria
2. Subject has a target lesion in a vessel with less than 3 mm in diameter.
3. Subject is participating in another device or drug clinical trial that interferes with this protocol and confounds results.
4. Treatment plan includes use of a thrombectomy and/or atherectomy device other than RotarexTM Rotational Excisional Atherectomy System.
5. Life expectancy is below 1 year.
6. Pregnant, planning to become pregnant during the course of the study or nursing a child.
22 Years
ALL
No
Sponsors
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C. R. Bard
INDUSTRY
Responsible Party
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Principal Investigators
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Prakash Krishnan, MD, FACC
Role: PRINCIPAL_INVESTIGATOR
The Icahn School of Medicine, The Mount Sinai Health System
Todd L Berland, MD, FACS
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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Radiology and Imaging Specialists
Lakeland, Florida, United States
Vital Heart and Vein
Humble, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BDPI-25-001
Identifier Type: -
Identifier Source: org_study_id