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Atherectomy Device
Atherectomy Devices for Peripheral Arterial Disease
N/A
Waitlist Available
Led By Anvar Babaev
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0, immediately before and after procedure
Awards & highlights
Study Summary
This trial will compare the effectiveness of two different devices for treating peripheral artery disease.
Who is the study for?
This trial is for adults over 18 with symptomatic obstructive disease in the femoro-popliteal artery, which is a blood vessel in the leg. Participants must have a certain level of blockage and be able to attend follow-up visits. Pregnant women, those with severe allergies to contrast dye or specific medications, or individuals currently in other studies are excluded.Check my eligibility
What is being tested?
The study compares two FDA-cleared devices for clearing plaque from arteries: CSI's DIAMONDBACK 360® Orbital Atherectomy System (OAS) and Medtronic's Hawkone Directional Atherectomy System (DAS). Each participant will randomly receive one device treatment followed by a drug-coated balloon therapy, assessed via ultrasound.See study design
What are the potential side effects?
Potential side effects may include reactions to contrast dye used during imaging, bleeding complications due to antiplatelet or anticoagulant drugs used post-procedure, and risks associated with the mechanical removal of arterial plaque such as vessel damage.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 0, immediately before and after procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0, immediately before and after procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Minimal Luminal Area
Change in Percentage Diameter Stenosis (%DS)
Secondary outcome measures
Change in Percentage Plaque Volume
Trial Design
2Treatment groups
Active Control
Group I: CSI's DIAMONDBACK 360® Peripheral Orbital Atherectomy (OAS)Active Control1 Intervention
OAS (using CSI device) followed by Inpact Admiral drug coated balloon (DCB)
Group II: Medtronic's Hawkone Directional Atherectomy system (DAS)Active Control1 Intervention
DAS (using the Hawkone device) followed by DCB
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Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,367 Previous Clinical Trials
839,627 Total Patients Enrolled
4 Trials studying Peripheral Arterial Disease
889 Patients Enrolled for Peripheral Arterial Disease
Anvar BabaevPrincipal InvestigatorNYU Langone Health
Anvar Babaev, MD, PhDPrincipal InvestigatorNYU Langone Health
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a severe narrowing of an artery, as determined by a special analysis called Qualitative Comparative Analysis (QCA).The combined length of all the tumors in your body is between 80 and 150 millimeters.You have had surgery on the main artery in your leg to treat clogged arteries.You have a treatment plan that includes specific types of laser, brachytherapy, or atherectomy procedures, except for OAS or DAS.Your platelet count is too low or too high, or you have a history of bleeding problems.You have a known blood clotting problem.You are currently undergoing dialysis or taking medication that weakens your immune system.You have had bleeding in your head or stomach in the last 3 months.You have good blood flow to your ankle or foot with no planned surgery.You are 18 years old or older.You've had a stent placed in the area being studied.You have an aneurysm in the blood vessel being studied.The treatment is meant for fixing narrowed blood vessels with a stent in the arms or legs.The blood vessel has a sharp bend or twist that makes it unsafe to use the atherectomy device.You are allergic to medications that prevent blood clots.You have had a major injury, surgery, or organ biopsy in the last 14 days.You have ongoing symptoms of reduced blood flow in your legs.The area of concern is in the upper leg or behind the knee.The blood vessel being studied is between 3.0 and 6.5 millimeters in size.You are eligible for a specific type of procedure using a medical device called OAS or DAS, as directed by their guidelines.
Research Study Groups:
This trial has the following groups:- Group 1: CSI's DIAMONDBACK 360® Peripheral Orbital Atherectomy (OAS)
- Group 2: Medtronic's Hawkone Directional Atherectomy system (DAS)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the primary goal of this medical research endeavor?
"This 12 Month experiment aims to gauge changes in the minimal luminal area. Secondary assessments include evaluating plaque burden reduction, percentage of plaque volume and overall amount of removed plaque using intravascular ultrasound (IVUS) pre-treatment and post atherectomy measurements."
Answered by AI
Is registration still open for the current trial?
"Clinicaltrials.gov attests that this research initiative, which has a starting date of March 23rd 2018 and an ending date of July 26th 2022, is no longer looking for participants at the present moment; however there are over two-hundred other trials seeking volunteers currently."
Answered by AI
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