Rotarex Atherectomy for Peripheral Artery Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment for individuals with peripheral artery disease, a condition that reduces blood flow to the legs. The treatment employs the Rotarex Rotational Excisional Atherectomy System, a device designed to remove blockages in blood vessels. Suitable candidates for this trial have leg artery blockages treatable with this device and experience symptoms like leg pain or difficulty walking. The trial aims to evaluate the treatment's effectiveness and gather information on its safety. As an unphased trial, participants can contribute to pioneering research that may lead to new treatment options for peripheral artery disease.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that the Rotarex(TM) Rotational Excisional Atherectomy System is safe for treating Peripheral Artery Disease?
Research has shown that the Rotarex™ Rotational Excisional Atherectomy System is generally well-tolerated. In the iDissection study, two cases of blockages occurred due to debris, with one linked to the Rotarex system. Fortunately, both cases were treated successfully without lasting issues.
The Rotarex system is a minimally invasive tool that effectively removes plaque and blood clots from leg arteries, helping to open blocked blood vessels.
While no serious side effects have been reported, minor complications can occur. Overall, the system appears safe based on current research. However, discussing potential risks with a doctor before joining any trial is important.12345Why are researchers excited about this trial?
Unlike traditional treatments for Peripheral Artery Disease (PAD), which often involve stents or bypass surgery, the Rotarex(TM) Rotational Excisional Atherectomy System offers a minimally invasive approach. This device works by physically removing plaque from the arteries rather than just compressing it against the artery wall. Researchers are excited about this system because it can potentially reduce recovery time and lower the risk of complications associated with more invasive procedures. Additionally, the Rotarex system aims to improve blood flow more effectively by directly excising the blockage, offering a promising alternative for patients with PAD.
What evidence suggests that the Rotarex(TM) Rotational Excisional Atherectomy System is effective for Peripheral Artery Disease?
Studies have shown that the Rotarex™ Rotational Excisional Atherectomy System effectively treats peripheral artery disease (PAD). This system clears plaque and blood clots from the arteries, restoring blood flow. One study found that patients with femoropopliteal arterial disease treated with this system experienced positive outcomes. Specifically, after 12 months, 92.3% of these patients had clear arteries, indicating a high success rate. Overall, the Rotarex™ system shows promise for improving blood flow in people with PAD.12346
Who Is on the Research Team?
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
Are You a Good Fit for This Trial?
This trial is for adults over 22 with Peripheral Arterial Disease who have specific types of chronic or acute limb ischemia. Participants must have a lesion treatable by the Rotarex system, be able to cross the lesion with a guidewire, and have at least one unblocked artery to the foot (for chronic cases). Consent is required.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Subjects are treated with the Rotarex(TM) Rotational Excisional Atherectomy System
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Rotarex(TM) Rotational Excisional Atherectomy System
Trial Overview
The XTRACT Registry study is observing how well the Rotarex(TM) System works in real-world settings for patients with arterial blockages in their legs. It's a single-group study meaning everyone gets this treatment; there's no comparison group.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Subjects treated with RotarexTM Rotational Excisional Atherectomy System
Find a Clinic Near You
Who Is Running the Clinical Trial?
C. R. Bard
Lead Sponsor
Timothy M. Ring
C. R. Bard
Chief Executive Officer since 2003
Bachelor of Science in Industrial and Labor Relations from Cornell University
Dr. Cimler
C. R. Bard
Chief Medical Officer since 2017
Ph.D. in Pharmacology
Citations
Rotarex™ Rotational Excisional Atherectomy System
The Rotarex™ Atherectomy System is designed to efficiently remove both plaque and thrombus by utilizing three distinct mechanisms of action to treat PAD lesions ...
Results of the iDissection Rotarex Study
Conclusions: The Rotarex device is an effective atherectomy device in treating complex femoropopliteal arterial disease. A high frequency of ...
BD to Initiate Real-World Patient Data Registry for the ...
The Rotarex™ Atherectomy System is a minimally invasive solution designed to efficiently remove both plaque and thrombus in peripheral arteries.
Results of the iDissection Rotarex Study
The Rotarex device is an effective atherectomy device in treating complex femoropopliteal arterial disease. A high frequency of adventitial ...
Peripheral Atherectomy and Thrombectomy Devices
At 12-months follow-up, the primary clinical success/patency rate was 92.3 % and the secondary clinical success/patency rate was 91.4 %. Rate of limb salvage ...
6.
vascularnews.com
vascularnews.com/bd-to-initiate-real-world-patient-registry-for-rotarex-atherectomy-system/BD to initiate real-world patient registry for Rotarex ...
BD has plans to initiate a patient data registry for the Rotarex atherectomy system to measure real-world outcomes in patients with PAD.
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.