Rotarex System for Peripheral Artery Disease
Rotarex(TM) Rotational Excisional Atherectomy System
Arterial Occlusive Diseases+4
+ Arteriosclerosis
+ Cardiovascular Diseases
Treatment Study
Summary
Study start date: September 29, 2025
Actual date on which the first participant was enrolled.This study is focused on evaluating a medical device called the Rotarex Rotational Excisional Atherectomy System for treating Peripheral Artery Disease (PAD). PAD is a condition where narrowed arteries reduce blood flow to the limbs, often causing pain and mobility issues. By assessing the real-world use of this device, the study aims to understand how well it helps patients with PAD and to gather more data on its effectiveness and safety. This research is crucial as it could lead to better treatment options for those affected by PAD, potentially improving their quality of life. Participants in this study will undergo treatment with the Rotarex device, which is designed to clear blocked arteries and restore blood flow. This is an interventional study, meaning it involves active treatment rather than just observation. The study plans to recruit around 600 subjects, who will be monitored to see how their condition improves after using the device. Although specific outcomes are not listed, the study will likely measure improvements in symptoms and any side effects or complications to evaluate the device's overall performance in real-world settings.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.600 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 22 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Radiology and Imaging Specialists
Lakeland, United StatesOpen Radiology and Imaging Specialists in Google MapsVital Heart and Vein
Humble, United States