NCT07016698

Brief Summary

The XTRACT Registry is a prospective, single arm multicenter study on the use of on the Rotarex(TM) Rotational Excisional Atherectomy System.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
38mo left

Started Sep 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress16%
Sep 2025May 2029

First Submitted

Initial submission to the registry

May 28, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 12, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

September 29, 2025

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2029

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2029

Last Updated

December 17, 2025

Status Verified

December 1, 2025

Enrollment Period

3.5 years

First QC Date

May 28, 2025

Last Update Submit

December 12, 2025

Conditions

Peripheral Arterial Disease(PAD)

Keywords

RotarexPAD

Outcome Measures

Primary Outcomes (2)

  • Procedural Success

    Procedural Success defined as the rate of successful revascularization of target lesion (residual stenosis/thrombus ≤30%) following index procedure.

    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

    30 days post index procedure

Study Arms (1)

Rotarex(TM) Rotational Excisional Atherectomy System

OTHER

Subjects treated with RotarexTM Rotational Excisional Atherectomy System

Device: Rotarex(TM) Rotational Excisional Atherectomy System

Interventions

Rotarex(TM) Rotational Excisional Atherectomy SystemDEVICE

Subjects treated with Rotarex(TM) Rotational Excisional Atherectomy System

Rotarex(TM) Rotational Excisional Atherectomy System

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Radiology and Imaging Specialists

Lakeland, Florida, 33805, United States

RECRUITING

Vital Heart and Vein

Humble, Texas, 77338, United States

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Officials

  • Prakash Krishnan, MD, FACC

    The Icahn School of Medicine, The Mount Sinai Health System

    PRINCIPAL INVESTIGATOR

  • Todd L Berland, MD, FACS

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Adrija Sharma, PhD

CONTACT

19014578360adrija.sharma@bd.com

Talar Saber

CONTACT

talar.saber@bd.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2025

First Posted

June 12, 2025

Study Start

September 29, 2025

Primary Completion (Estimated)

March 31, 2029

Study Completion (Estimated)

May 31, 2029

Last Updated

December 17, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(2)