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XTRACT Registry for Rotarex™ System in PAD

This study, called the XTRACT Registry, is looking at how well the Rotarex™ Rotational Excisional Atherectomy System works for people with Peripheral Arterial Disease (PAD). PAD is a condition where narrowed arteries reduce blood flow to your limbs. The study aims to enroll about 600 participants. To join, you need to be at least 22 years old and have PAD in your leg arteries that can be treated with the Rotarex™ system. Researchers will look at how successful the procedure is right away and if there are any major problems within 30 days after the procedure. The current recruitment status is unclear.

Study design
This is a single-arm study, meaning all participants receive the same treatment. It plans to enroll approximately 600 subjects.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will check for major complications up to 30 days after your procedure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07016698

Real-World Registry of the Rotarex(TM) Rotational Excisional Atherectomy System (XTRACT Registry)

Recruiting
NAAges 22+InterventionalTreatment
C. R. Bard
~600 participants
Updated 2025-12-17 on ClinicalTrials.gov
What's tested:Rotarex(TM) Rotational Excisional Atherectomy System

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Procedural Success
Measured over Immediate Post Index Procedure
+1 more outcome measured

Conditions

Peripheral Arterial Disease(PAD)

Explore related trials

Peripheral Artery Disease

Where it's being run

2 sites across 2 states
Florida1
Texas1

Study leadership

  • 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

Who to contact

Adrija Sharma, PhD
[email protected]
19014578360
Email the study team

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What this trial measures

  • Procedural SuccessImmediate 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 complications30 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