NCT07016698 Real-World Registry of the Rotarex(TM) Rotational Excisional Atherectomy System (XTRACT Registry)
| NCT ID | NCT07016698 |
| Status | Recruiting |
| Phase | — |
| Sponsor | C. R. Bard |
| Condition | Peripheral Arterial Disease(PAD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2025-09-29 |
| Primary Completion | 2029-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 600 participants in total. It began in 2025-09-29 with a primary completion date of 2029-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The XTRACT Registry is a prospective, single arm multicenter study on the use of on the Rotarex(TM) Rotational Excisional Atherectomy System.
Eligibility Criteria
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.
Contact & Investigator
Prakash Krishnan, MD, FACC
PRINCIPAL INVESTIGATOR
The Icahn School of Medicine, The Mount Sinai Health System
Frequently Asked Questions
Who can join the NCT07016698 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, studying Peripheral Arterial Disease(PAD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07016698 currently recruiting?
Yes, NCT07016698 is actively recruiting participants. Contact the research team at adrija.sharma@bd.com for enrollment information.
Where is the NCT07016698 trial being conducted?
This trial is being conducted at Lakeland, United States, Humble, United States.
Who is sponsoring the NCT07016698 clinical trial?
NCT07016698 is sponsored by C. R. Bard. The principal investigator is Prakash Krishnan, MD, FACC at The Icahn School of Medicine, The Mount Sinai Health System. The trial plans to enroll 600 participants.