RECRUITINGINTERVENTIONAL
Real-World Registry of the Rotarex(TM) Rotational Excisional Atherectomy System (XTRACT Registry)
A Prospective, Multicenter, Single Arm, Real-World Registry Assessing the Clinical Use of the Rotarex(TM) Rotational Excisional Atherectomy System (XTRACT Registry)
About This Trial
The XTRACT Registry is a prospective, single arm multicenter study on the use of on the Rotarex(TM) Rotational Excisional Atherectomy System.
Who May Be Eligible (Plain English)
Who May Qualify:
1. Subject or legally authorized representative provides written willing to sign a consent form using an willing to sign a consent form Form (ICF) that is reviewed and approved by the IRB for the site.
2. Subject is ≥22 years old at the time of signing the willing to sign a consent form.
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).
Who Should NOT Join This Trial:
1. Subject is unable or unwilling to comply with follow-up procedures and visits.
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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
1. Subject or legally authorized representative provides written informed consent using an Informed Consent Form (ICF) that is reviewed and approved by the IRB for the site.
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:
1. Subject is unable or unwilling to comply with follow-up procedures and visits.
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.
Treatments Being Tested
DEVICE
Rotarex(TM) Rotational Excisional Atherectomy System
Subjects treated with Rotarex(TM) Rotational Excisional Atherectomy System
Locations (2)
Radiology and Imaging Specialists
Lakeland, Florida, United States
Vital Heart and Vein
Humble, Texas, United States