Peripheral Arterial Disease(PAD)NCT07016698
Real-World Registry of the Rotarex(TM) Rotational Excisional Atherectomy System (XTRACT Registry)
A study testing Rotarex(TM) Rotational Excisional Atherectomy System in people with Peripheral Arterial Disease(PAD), run by C. R. Bard at 2 sites in United States.
Trial summary
The XTRACT Registry is a prospective, single arm multicenter study on the use of on the Rotarex(TM) Rotational Excisional Atherectomy System. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Peripheral Arterial Disease(PAD)
- What is being tested?
- Rotarex(TM) Rotational Excisional Atherectomy System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Sep 2025to 31 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Talar Saber contact
United States2 sites, 2 recruiting
- Recruiting
Vital Heart and Vein
Humble, Texas, 77338
Adrija Sharma, 901-457-8360, adrija.sharma@bd.com
- Recruiting
Radiology and Imaging Specialists
Lakeland, Florida, 33805
Adrija Sharma, 901-457-8360, adrija.sharma@bd.com
About this study
Official title: A Prospective, Multicenter, Single Arm, Real-World Registry Assessing the Clinical Use of the Rotarex(TM) Rotational Excisional Atherectomy System (XTRACT Registry)
The XTRACT Registry is a prospective, single arm multicenter study on the use of on the Rotarex(TM) Rotational Excisional Atherectomy System.
Read the detailed description
The study will recruit approximately 600 subjects treated for PAD.
- Conditions
- Peripheral Arterial Disease(PAD)
- Being tested
- Rotarex(TM) Rotational Excisional Atherectomy System
- Keywords
- Rotarex, PAD
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotarex(TM) Rotational Excisional Atherectomy SystemDevice
Subjects treated with Rotarex(TM) Rotational Excisional Atherectomy System
| Study group | Role | What they receive |
|---|---|---|
| Rotarex(TM) Rotational Excisional Atherectomy System | Other | Subjects treated with RotarexTM Rotational Excisional Atherectomy System Receives: Device: Rotarex(TM) Rotational Excisional Atherectomy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural Success
Procedural Success defined as the rate of successful revascularization of target lesion (residual stenosis/thrombus ≤30%) following index procedure.
Measured: 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
Measured: 30 days post index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start29 Sep 2025
- Primary completion31 Mar 2029 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial Disease(PAD)Studies of the same condition, open and under way.
- More trials run by C. R. BardThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prakash Krishnan, MD, FACC, Principal investigator, The Icahn School of Medicine, The Mount Sinai Health SystemTodd L Berland, MD, FACS, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07016698
- Sponsor's protocol ID
- BDPI-25-001
- Status last verified
- Dec 2025
- First submitted
- 28 May 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single Arm, Real-World Registry Assessing the Clinical Use of the Rotarex(TM) Rotational Excisional Atherectomy System (XTRACT Registry)
- ClinicalTrials.gov ID
- NCT07016698
- Acronym / sponsor ID
- BDPI-25-001
- Conditions
- Peripheral Arterial Disease(PAD)
- Keywords
- Rotarex, PAD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Study start
- 29 Sep 2025 (actual)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 12 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rotarex(TM) Rotational Excisional Atherectomy System | Other | Device: Rotarex(TM) Rotational Excisional Atherectomy SystemSubjects treated with RotarexTM Rotational Excisional Atherectomy System |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rotarex(TM) Rotational Excisional Atherectomy SystemSubjects treated with Rotarex(TM) Rotational Excisional Atherectomy System | Device | Rotarex(TM) Rotational Excisional Atherectomy System |
Primary outcome
Procedural Success
Time frame: 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
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Talar Saber contact
Prakash Krishnan, MD, FACC principal investigator
The Icahn School of Medicine, The Mount Sinai Health System
Todd L Berland, MD, FACS principal investigator
NYU Langone Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rotarex(TM) Rotational Excisional Atherectomy System in people with Peripheral Arterial Disease(PAD), run by C. R. Bard at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adrija Sharma, PhD (19014578360, adrija.sharma@bd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural Success (time frame: Immediate Post Index Procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.