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New treatment option for Peripheral Arterial Disease(PAD)
Official title Real-World Registry of the Rotarex(TM) Rotational Excisional Atherectomy System (XTRACT Registry)
ClinicalTrials.gov ID: NCT07016698
What this study is testing
- What it's testing
- The XTRACT Registry is a prospective, single arm multicenter study on the use of on the Rotarex(TM) Rotational Excisional Atherectomy System.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older
You may be able to join if
- Subject or legally authorized representative provides written informed consent using an Informed Consent Form (ICF) that is reviewed and approved by...
- Subject is ≥22 years old at the time of signing the informed consent.
- Subject must have a lesion(s) in their infra-inguinal peripheral arteries that can be treated with the RotarexTM Rotational Excisional Atherectomy...
- Rutherford 2-5 for chronic limb ischemia and Rutherford I to IIb for acute limb ischemia.
- Target lesion can be crossed intra-luminally by guidewire.
You likely can't join if
- Subject is unable or unwilling to comply with follow-up procedures and visits.
- Subject has a target lesion in a vessel with less than 3 mm in diameter.
- Subject is participating in another device or drug clinical trial that interferes with this protocol and confounds results.
- Treatment plan includes use of a thrombectomy and/or atherectomy device other than RotarexTM Rotational Excisional Atherectomy System.
- Life expectancy is below 1 year.
- Pregnant, planning to become pregnant during the course of the study or nursing a child.
See the full eligibility criteria
- 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.
- Subject is ≥22 years old at the time of signing the informed consent.
- 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).
- Rutherford 2-5 for chronic limb ischemia and Rutherford 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% stenosis as confirmed by angiography) (ChLI Cohort only, not applicable to ALI Cohort).
- Subject is unable or unwilling to comply with follow-up procedures and visits.
- Subject has a target lesion in a vessel with less than 3 mm in diameter.
- Subject is participating in another device or drug clinical trial that interferes with this protocol and confounds results.
- Treatment plan includes use of a thrombectomy and/or atherectomy device other than RotarexTM Rotational Excisional Atherectomy System.
- Life expectancy is below 1 year.
- Pregnant, planning to become pregnant during the course of the study or nursing a child.
The study team makes the final eligibility decision.
Where it's taking place
- Lakeland, Florida, United States
- Humble, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lakeland, Florida, United States; Humble, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.