An interventional study of Rotarex(TM) Rotational Excisional Atherectomy System in Peripheral Arterial Disease(PAD), sponsored by C. R. Bard. Recruiting at 2 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2025-12-17.
Sponsored by C. R. Bard (part of Becton, Dickinson and Company) · Not applicable, Interventional, and Treatment
The XTRACT Registry is a prospective, single arm multicenter study on the use of on the Rotarex(TM) Rotational Excisional Atherectomy System.
The study will recruit approximately 600 subjects treated for PAD.
1,377 studies on the registry are indexed under Peripheral Arterial Disease; 275 are open to participants now.
This study's planned enrollment of 600 is above the median of 70 across 927 interventional studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →C. R. Bard is the lead sponsor of 117 studies on the registry; 6 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 13 (76%) have results posted.
First submitted after C. R. Bard became part of Becton, Dickinson and Company.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects treated with RotarexTM Rotational Excisional Atherectomy System
Device: Rotarex(TM) Rotational Excisional Atherectomy System
Subjects treated with Rotarex(TM) Rotational Excisional Atherectomy System
Procedural Success
Procedural Success defined as the rate of successful revascularization of target lesion (residual stenosis/thrombus ≤30%) following index procedure.
Time frame: Immediate Post Index Procedure
Freedom from major complications
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
Time frame: 30 days post index procedure
Plan to share: No
No publications or documents are linked to this record.
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