Peripheral Arterial Disease(PAD)
Conditions
Keywords
Rotarex, PAD
Brief summary
The XTRACT Registry is a prospective, single arm multicenter study on the use of on the Rotarex(TM) Rotational Excisional Atherectomy System.
Detailed description
The study will recruit approximately 600 subjects treated for PAD.
Interventions
DEVICERotarex(TM) Rotational Excisional Atherectomy System
Subjects treated with Rotarex(TM) Rotational Excisional Atherectomy System
Sponsors
C. R. Bard
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedural Success | Immediate Post Index Procedure | Procedural Success defined as the rate of successful revascularization of target lesion (residual stenosis/thrombus ≤30%) following index procedure. |
| Freedom from major complications | 30 days post index procedure | Freedom from composite of device and/or procedure related perioperative (≤30 day) death, unplanned target limb major amputation (above the ankle), and clinically driven target lesion revascularization (CD-TLR) at 30 days post index procedure |
Countries
United States
Contacts
Primary ContactAdrija Sharma, PhD
Backup ContactTalar Saber
Outcome results
None listed